NCT00468689已完成1 期
A Two-Part Dose-Rising Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SB-751689 When Administered as an Oral Formulation at Supratherapeutic Dose Levels in Healthy Adult Subjects.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Safety and tolerability of SB-751689 doses determined from clinical safety and tolerability data from all adverse event reporting, 12-lead ECGs, vital signs, nursing/physician observation, and safety laboratory tests
研究概览
简要总结
This study will evaluate the safety, tolerability and exposure of SB-751689 when administered alone at supratherapeutic doses and when SB-751689 is co administered with ketoconazole, a PGP/CYP3A4 inhibitor that increases exposure of SB-751689. Data from this study will enable the planning and conduct of a QTc study for SB-751689.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults aged 18-60yrs, with BMI of 19-31kg/m
- •Females must be of non-childbearing potential.
- •Subjects must be able to give consent and comply with restrictions of study.
排除标准
- •Clinically relevant abnormality from history, physical, 12-lead ECG, Holter monitoring, or clinical laboratory examination.
- •Positive urine drug screen.
- •Positive urine test for alcohol.
- •Contine levels indicative of smoking.
- •Positive HIV or Hep B and/or C assay.
- •History or smoking in last year or >10 pack/year history of smoking overall.
- •History of regular alcohol consumption (7 units/week for women and 14 units/week for men) within 6 months of study.
- •History of drug abuse within 6 months of study.
- •Participation in another drug trial within 30 days of first dose.
- •Exposure to more than 4 new chemical entities within 12 months of first dose.
- •Use of prescription and non-prescription drugs including dietary supplements, herbals and St. John's wort within 14 days of first dose.
- •Consumption of red wine, grapefruit, grapefruit juice and grapefruit products within 14 days of first dose.
- •Donation of blood in excess of 500 mL within 56 days of dosing.
- •Evidence of renal, hepatic or biliary impairment.
- •History of serious gastrointestinal disease or history of gastrointestinal surgical procedure that might affect absorption of study drug.
- •History of sensitivity to any of the study medications.
- •History of clinically significant cardiovascular disease.
- •History of pernicious anemia, pancreatitis, osteosarcoma or kidney stones. Medical conditions which might alter bone metabolism.
- •Liver function tests above ULN at screening and PTH, glucose, and CPK outside the reference range at screening.
- •Males unwilling to refrain from fathering a child during the study and for 14 days following the last dose of study medication.
结局指标
主要结局
Safety and tolerability of SB-751689 doses determined from clinical safety and tolerability data from all adverse event reporting, 12-lead ECGs, vital signs, nursing/physician observation, and safety laboratory tests
时间窗: throughout the study
次要结局
- PK and of SB-751689 as determined by AUC, Cmax, tmax, and half-life. PD effects (PTH, serum Ca) as determined by AUC, Emax, tmax, maximum change and % change from baseline, duration of effect, duration above ULN for PTH.(throughout the study)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
A Study of LY3819469 in Healthy ParticipantsHealthyNCT04914546Eli Lilly and Company66
已完成
1 期
Single Rising Dose Study of MK-8723 in Healthy Participants and Participants With Immune Thrombocytopenia Purpura (MK-8723-001)Immune Thrombocytopenia PurpuraNCT01963260Merck Sharp & Dohme LLC50
已完成
1 期
Study of a Single Dose of Danicopan in Healthy ParticipantsHealthyNCT04889677Alexion Pharmaceuticals, Inc.44
已完成
1 期
A Study to Assess the Safety and Tolerability of Single Ascending Doses of REGN1033(SAR391786)Healthy VolunteersNCT01507402Regeneron Pharmaceuticals76
已完成
1 期
A First Human Dose Study to Investigate Safety and Tolerability of LY2979165 in Healthy VolunteersBipolar DisorderNCT01248052Eli Lilly and Company25