A PHASE 1 STUDY TO ASSESS THE MASS BALANCE, EXCRETION, AND PHARMACOKINETICS OF [14C]-GBT021601, AN ORAL HEMOGLOBIN SPOLYMERIZATION INHIBITOR, IN HEALTHY PARTICIPANTS
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- GBT021601 Concentration in Whole Blood and Plasma at Predose
研究概览
简要总结
An Open-label Study of GBT021601 in 8 to 10 healthy male or female participants to evaluate the absorption, distribution, metabolism, and excretion (ADME) of GBT021601.
详细描述
This is an open-label Study administering GBT021601 as a single oral dose of 200 mg in healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI): 18.0 to 27.0 kg/m2, inclusive, at screening.
- •Body weight ≥ 50 kg at screening
- •Females must be nonlactating and nonpregnant (as confirmed by a negative serum pregnancy test at screening and admission for all females), or of nonchildbearing potential (ie, either surgically sterilized or physiologically incapable of becoming pregnant, or at least 1 year postmenopausal [defined as at least 12 months no menses, and confirmed by a follicle-stimulating hormone test, at screening]).
- •Creatinine clearance (glomerular filtration rate) as estimated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula: ≥90 mL/min, at screening.
排除标准
- •History or presence of conditions which, in the opinion of the Investigator, are known to interfere with the ADME of drugs, such as previous surgery on the gastrointestinal tract (including removal of parts of the stomach, bowel, liver, gall bladder, or pancreas). Participants who have a history of appendectomy are eligible for enrollment.
- •History of chronic constipation, or recent complaints of an irregular defecation
- •Significant and/or acute illness at screening or within 5 days prior to study drug administration that may impact safety assessments, in the opinion of the Investigator.
- •Known personal or family history of congenital long QT syndrome or known family history of sudden death.
- •Participation in another ADME study with a radiation burden >0.1 mSv in the period of 1 year prior to screening.
研究组 & 干预措施
Treatment
open-label GBT021601
干预措施: GBT021601 (Drug)
结局指标
主要结局
GBT021601 Concentration in Whole Blood and Plasma at Predose
时间窗: Predose (within 60 minutes prior to GBT021601 dosing)
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at Predose
时间窗: Predose (within 60 minutes prior to 14C-GBT021601 dosing)
Data reported in microgram equivalent per milliliter (mcgEq/mL).
GBT021601 Concentration in Whole Blood and Plasma at 0.25 Hours
时间窗: 0.25 hours post dosing on Day 1
14C-GBT021601 Total Radioactivity Concentrations in Whole Blood and Plasma at 0.25 Hours
时间窗: 0.25 hours post dosing on Day 1
GBT021601 Concentration in Whole Blood and Plasma at 0.50 Hours
时间窗: 0.50 hours post dosing on Day 1
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 0.50 Hours
时间窗: 0.50 hours post dosing on Day 1
GBT021601 Concentration in Whole Blood and Plasma at 1 Hours
时间窗: 1 hours post dosing on Day 1
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 6 Hours
时间窗: 6 hours post dosing on Day 1
GBT021601 Concentration in Whole Blood and Plasma at 8 Hours
时间窗: 8 hours post dosing on Day 1
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 8 Hours
时间窗: 8 hours post dosing on Day 1
GBT021601 Concentration in Whole Blood and Plasma at 12 Hours
时间窗: 12 hours post dosing on Day 1
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 12 Hours
时间窗: 12 hours post dosing on Day 1
GBT021601 Concentration in Whole Blood and Plasma at 24 Hours
时间窗: 24 hours post dosing on Day 1
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 24 Hours
时间窗: 24 hours post dosing on Day 1
GBT021601 Concentration in Whole Blood and Plasma at 48 Hours
时间窗: 48 hours post dosing
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 48 Hours
时间窗: 48 hours post dosing
GBT021601 Concentration in Whole Blood and Plasma at 72 Hours
时间窗: 72 hours post dosing
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 1 Hours
时间窗: 1 hours post dosing on Day 1
GBT021601 Concentration in Whole Blood and Plasma at 2 Hours
时间窗: 2 hours post dosing on Day 1
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 2 Hours
时间窗: 2 hours post dosing on Day 1
GBT021601 Concentration in Whole Blood and Plasma at 3 Hours
时间窗: 3 hours post dosing on Day 1
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 3 Hours
时间窗: 3 hours post dosing on Day 1
GBT021601 Concentration in Whole Blood and Plasma at 4 Hours
时间窗: 4 hours post dosing on Day 1
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 4 Hours
时间窗: 4 hours post dosing on Day 1
GBT021601 Concentration in Whole Blood and Plasma at 6 Hours
时间窗: 6 hours post dosing on Day 1
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 72 Hours
时间窗: 72 hours post dosing
GBT021601 Concentration in Whole Blood and Plasma at 96 Hours
时间窗: 96 hours post dosing
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 96 Hours
时间窗: 96 hours post dosing
GBT021601 Concentration in Whole Blood and Plasma at 144 Hours
时间窗: 144 hours post dosing
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 144 Hours
时间窗: 144 hours post dosing
GBT021601 Concentration in Whole Blood and Plasma at 168 Hours
时间窗: 168 hours post dosing
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 168 Hours
时间窗: 168 hours post dosing
GBT021601 Concentration in Whole Blood and Plasma at 312 Hours
时间窗: 312 hours post dosing
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 312 Hours
时间窗: 312 hours post dosing
GBT021601 Concentration in Whole Blood and Plasma at 480 Hours
时间窗: 480 hours post dosing
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 480 Hours
时间窗: 480 hours post dosing
GBT021601 Concentration in Whole Blood and Plasma at 648 Hours
时间窗: 648 hours post dosing
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 648 Hours
时间窗: 648 hours post dosing
GBT021601 Concentration in Whole Blood and Plasma at 816 Hours
时间窗: 816 hours post dosing
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 816 Hours
时间窗: 816 hours post dosing
GBT021601 Concentration in Whole Blood and Plasma at 984 Hours
时间窗: 984 hours post dosing
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 984 Hours
时间窗: 984 hours post dosing
GBT021601 Concentration in Whole Blood and Plasma at 1320 Hours
时间窗: 1320 hours post dosing
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 1320 Hours
时间窗: 1320 hours post dosing
GBT021601 Concentration in Whole Blood and Plasma at 1656 Hours
时间窗: 1656 hours post dosing
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 1656 Hours
时间窗: 1656 hours post dosing
GBT021601 Concentration in Whole Blood and Plasma at 1992 Hours
时间窗: 1992 hours post dosing
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 1992 Hours
时间窗: 1992 hours post dosing
GBT021601 Concentration in Whole Blood and Plasma at 2328 Hours
时间窗: 2328 hours post dosing
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 2328 Hours
时间窗: 2328 hours post dosing
GBT021601 Concentration in Whole Blood and Plasma at 2664 Hours
时间窗: 2664 hours post dosing
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 2664 Hours
时间窗: 2664 hours post dosing
GBT021601 Concentration in Whole Blood and Plasma at 3240 Hours
时间窗: 3240 hours post dosing
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 3240 Hours
时间窗: 3240 hours post dosing
GBT021601 Concentration in Whole Blood and Plasma at 3576 Hours
时间窗: 3576 hours post dosing
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 3576 Hours
时间窗: 3576 hours post dosing
GBT021601 Concentration in Whole Blood and Plasma at 4248 Hours
时间窗: 4248 hours post dosing
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 4248 Hours
时间窗: 4248 hours post dosing
GBT021601 Concentration in Whole Blood and Plasma at 4920 Hours
时间窗: 4920 hours post dosing
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 4920 Hours
时间窗: 4920 hours post dosing
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 12-24 Hours
时间窗: 12-24 hours post dose
Cumulative Amount of [14C]-GBT021601 Total Radioactivity Excreted in Urine and Feces
时间窗: Day 1 (prior to dosing), after dosing from 0-6 hours, 6-12 hrs, 12-24 hrs postdose for urine, 24-hr intervals up to Day 29; 816 hrs , 984 hrs, 1320 hrs, 1656 hrs, 1992 hrs, 2328 hrs, 2664 hrs, 3240 hrs, 3576 hrs, 4248 hrs, and 4920 hrs post-dose
Data are reported as aggregate of all scheduled time points.
Cumulative Fraction of [14C]-GBT021601 Total Radioactivity Excreted in Urine and Feces
时间窗: Day 1 (prior to dosing), after dosing from 0-6 hours, 6-12 hrs, 12-24 hrs postdose for urine, 24-hr intervals up to Day 29; 816 hrs , 984 hrs, 1320 hrs, 1656 hrs, 1992 hrs, 2328 hrs, 2664 hrs, 3240 hrs, 3576 hrs, 4248 hrs, and 4920 hrs post-dose
Data are reported as aggregate of all scheduled time points.
Area Under the Plasma Concentration-Time Curve From Time Zero (0) to 24 Hours (AUC0-24) of GBT021601 in Whole Blood and Plasma
时间窗: Day 1 (prior to dosing) at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours
Area under the plasma concentration-time curve up to 24 hours post dose. Data reported in Hour\*microgram/millimeter (h\*mcg/mL).
Area Under the Plasma Concentration-Time Curve From Time Zero (0) to 24 Hours (AUC0-24) of 14C-GBT021601 in Whole Blood and Plasma
时间窗: Day 1 (prior to dosing) at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours
Area under the plasma concentration-time curve up to 24 hours postdose. Data reported in hour\*microgram equivalent/milliliter (h\*mcgEq/mL).
Area Under the Concentration-Time From Time Zero to the Last Measurable Concentration (AUC0-last) of GBT021601 in Whole Blood and Plasma
时间窗: Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose
Area Under the Concentration-Time From Time Zero to the Last Measurable Concentration (AUC0-last) of 14C-GBT021601 in Whole Blood and Plasma
时间窗: Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of GBT021601 in Whole Blood and Plasma
时间窗: Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose
Area under the plasma concentration-time curve from time 0 to infinity calculated as: AUC0-inf=AUC0-t+Clast/kel, where Clast is the last measurable plasma concentration.
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of 14C-GBT021601 in Whole Blood and Plasma
时间窗: Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose
Area under the plasma concentration-time curve from time 0 to infinity calculated as: AUC0-inf=AUC0-t+Clast/kel, where Clast is the last measurable plasma concentration and Kel is apparent terminal elimination rate constant.
Maximum Observed Concentration (Cmax) of GBT021601 in Whole Blood and Plasma
时间窗: Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose
Maximum Observed Concentration (Cmax) of 14C-GBT021601 in Whole Blood and Plasma
时间窗: Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose
Time to Attain Maximum Observed Concentration (Tmax) of GBT021601 in Whole Blood and Plasma
时间窗: Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose
Time to Attain Maximum Observed Concentration (Tmax) of 14C-GBT021601 in Whole Blood and Plasma
时间窗: Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose
Apparent Terminal Elimination Half-Life (t1/2) of GBT021601 in Whole Blood and Plasma
时间窗: Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose
Apparent terminal elimination half-life, calculated as 0.693/kel where kel is Apparent terminal elimination rate constant.
Apparent Terminal Elimination Half-Life (t1/2) of 14C-GBT021601 in Whole Blood and Plasma
时间窗: Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose
Apparent terminal elimination half-life, calculated as 0.693/kel where kel is Apparent terminal elimination rate constant.
Renal Clearance (CLR) of GBT021601 and 14C-GBT021601 in Urine
时间窗: Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose
Renal clearance was calculated as CLR = Ae0-inf/AUC0-inf. Where Ae indicates Cumulative amount of drug excreted and AUC0-inf indicates Area under the plasma concentration-time curve from time 0 to infinity.
Apparent Volume of Distribution at Terminal Phase (Vz/F) of GBT021601 in Whole Blood and Plasma
时间窗: Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose
Apparent volume of distribution at terminal phase, calculated as: (CL/F) Apparent total clearance, calculated as dose/AUC0-inf/Kel.
Apparent Volume of Distribution at Terminal Phase (Vz/F) of 14C-GBT021601 in Whole Blood and Plasma
时间窗: Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose
Apparent volume of distribution at terminal phase, calculated as: (CL/F) Apparent total clearance, calculated as dose/AUC0-inf/Kel.
Apparent Total Clearance (CL/F) of GBT021601 in Whole Blood and Plasma
时间窗: Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose
Apparent total clearance, calculated as dose/AUC0-inf.
Apparent Total Clearance (CL/F) of 14C-GBT021601 in Whole Blood and Plasma
时间窗: Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose
Apparent total clearance, calculated as dose/AUC0-inf.
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 0-6 Hours
时间窗: 0-6 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 6-12 Hours
时间窗: 6-12 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 0-24 Hours
时间窗: 0-24 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 24 Hours
时间窗: 24 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 48 Hours
时间窗: 48 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 72 Hours
时间窗: 72 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 96 Hours
时间窗: 96 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 120 Hours
时间窗: 120 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 144 Hours
时间窗: 144 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 168 Hours
时间窗: 168 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 192 Hours
时间窗: 192 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 216 Hours
时间窗: 216 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 240 Hours
时间窗: 240 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 264 Hours
时间窗: 264 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 288 Hours
时间窗: 288 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 312 Hours
时间窗: 312 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 336 Hours
时间窗: 336 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 360 Hours
时间窗: 360 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 384 Hours
时间窗: 384 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 408 Hours
时间窗: 408 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 432 Hours
时间窗: 432 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 456 Hours
时间窗: 456 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 480 Hours
时间窗: 480 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 504 Hours
时间窗: 504 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 528 Hours
时间窗: 528 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 552 Hours
时间窗: 552 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 576 Hours
时间窗: 576 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 600 Hours
时间窗: 600 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 624 Hours
时间窗: 624 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 648 Hours
时间窗: 648 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 816 Hours
时间窗: 816 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 984 Hours
时间窗: 984 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 1320 Hours
时间窗: 1320 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 1656 Hours
时间窗: 1656 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 1992 Hours
时间窗: 1992 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 2328 Hours
时间窗: 2328 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 2664 Hours
时间窗: 2664 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 3240 Hours
时间窗: 3240 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 3576 Hours
时间窗: 3576 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 4248 Hours
时间窗: 4248 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 4920 Hours
时间窗: 4920 hours post dose
次要结局
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)(From Day 1 up to maximum of Day 57)
- Number of Participants With Clinically Significant Laboratory Values(Day 1 of dosing to Day 207)
- Number of Participants With Clinically Significant Vital Signs Values(Day 1 of dosing to Day 207)
- Number of Participants With Clinically Significant ECG Values(Day 1)
- Number of Participants With Clinically Significant Physical Examination Values(Screening (-28 Day to -2 Day, day with respect to dosing))