A PHASE 1, RANDOMIZED, OPEN-LABEL, 2-SEQUENCE, 3-PERIOD STUDY TO CHARACTERIZE THE GASTROINTESTINAL TRANSIT OF A MODIFIED-RELEASE CAPSULE FORMULATION UNDER FASTED AND FED CONDITIONS BY SINGLE LABEL GAMMA SCINTIGRAPHY IN HEALTHY MALE ADULT PARTICIPANTS
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Gastric emptying time
研究概览
简要总结
The purpose of this study is to learn about how different forms of the study medicine called ritlecitinib pass the intestines of healthy male adults when taken with or without food.
This study is seeking healthy participants who have:
- Aged 18 years or older;
- male who are healthy as determined by medical assessment;
- BMI of 16-32 kg/m2, and a total body weight >45 kg (99 lb).
All participants in this study will receive a ritlecitinib oral dose in two different forms (solution without food, capsule with or without food).
The study will take up to 3 months, including the screening period and follow-up phone call. Participants will have to stay at the study clinic for at least 11 days. There will be 3 periods in total, and a washout period of at least 3 days between dosings in Period 1 and Period 2, and at least 7 days between dosings in Period 2 and Period 3 for this study. On day 1 of each period, participants will take one form of Riltecitinib without food for the first two periods and with food for the last period. Participants will have blood samples taken both before and after taking ritlecitinib. A follow-up phone call will be made at 28 to 35 days after the last study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male and female participants aged 18 years or older (or the minimum age of consent in accordance with local regulations) at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests.
- •BMI of 16-32 kg/m2, and a total body weight >45 kg (99 lb).
- •Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- •Capable of giving signed informed consent
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- •Participants with the acute or chronic infections or infection history
- •History of febrile illness within 5 days prior to the first dose of study intervention.
- •History of any lymphoproliferative disorder such as EBV related lymphoproliferative disorder, history of lymphoma, history of leukemia, or signs or symptoms suggestive of current lymphatic or lymphoid disease.
- •Known present or a history of malignancy other than a successfully treated or excised nonmetastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
- •History of active or latent Mycobacterium TBA: participant who is currently being treated for active or latent Mycobacterium TB infection or has a history of Mycobacterium TB must be excluded from the study.
- •Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- •Recent history of abnormal bowel movements, such as diarrhea, loose stools, or constipation, within 1 week prior to first dose.
研究组 & 干预措施
Treatment Sequence 1
Ritlecitinib 100 mg solution (fasted, Period 1), followed by ritlecitinib 100 mg MR capsule with 153Sm2O3 (fasted, Period 2), and followed by ritlecitinib 100 mg MR capsule with 153Sm2O3 (fed, Period 3).
干预措施: Ritlecitinib (Drug)
Treatment Sequence 2
Ritlecitinib 100 mg solution (fasted, Period 1), followed by ritlecitinib 100 mg MR capsule with 153Sm2O3 (fed, Period 2), and followed by ritlecitinib 100 mg MR capsule with 153Sm2O3 (fasted, Period 3).
干预措施: Ritlecitinib (Drug)
结局指标
主要结局
Gastric emptying time
时间窗: up to 48 hours post dose or as long as radioactivity is present in the GI tract (if it is shorter than 48 hours)
Gastric emptying metrics may include a) time of 1st GE; b) time(s) for GE 10%, 25%, 50%, 75%, 90% and complete gastric emptying time GE100%.
Colon arrival time
时间窗: up to 48 hours post dose or as long as radioactivity is present in the GI tract (if it is shorter than 48 hours)
Arrival time at the colon (ATC) metrics may include a) time(s) for ATC 10%, 25%, 50%, 75%, 90% and 100%.
Total transit time
时间窗: up to 48 hours post dose or as long as radioactivity is present in the GI tract (if it is shorter than 48 hours)
Residence time of the formulation in the gastrointestinal tract.
Site of capsule disintegration and MR microsphere dispersion
时间窗: up to 48 hours post dose or as long as radioactivity is present in the GI tract (if it is shorter than 48 hours)
The time and gastrointestinal location where the HPMC capsule(s) disintegrate and disperse the drug formulation.
Small intestine residence/transit time
时间窗: up to 48 hours post dose or as long as radioactivity is present in the GI tract (if it is shorter than 48 hours)
Small Intestine transit metrics may include time for 10%, 25%, 50%, 75%, 90% and 100% of the formulation to transit through the small intestine.
Colon (ascending, transverse, descending) residence/transit time
时间窗: up to 48 hours post dose or as long as radioactivity is present in the GI tract (if it is shorter than 48 hours)
The residence time of the formulation in the three primary regions of the large intestine to include the ascending, transverse and descending colon.
次要结局
- Maximum plasma concentration (Cmax)(Solution: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose. Capsules: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose.)
- Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)(Solution: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose. Capsules: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose.)
- Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast)(Solution: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose. Capsules: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose.)
- Frequency of abnormal clinical laboratory tests(Baseline up to Day 11)
- Frequency of adverse events(Baseline up to Day 35)
- Time for Cmax (Tmax)(Solution: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose. Capsules: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose.)
- Terminal half-life (t1/2)(Solution: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose. Capsules: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose.)
- Frequency of abnormal vital signs(Baseline up to Day 11)
- Frequency of abnormal 12-lead ECG(Baseline up to Day 11)