临床试验/NCT02018536

NCT02018536已完成1 期

A Phase 1, Double-blind, Placebo-controlled, Randomized, Single Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of GSK2336805 (Part 1), Followed by an Open-label, Randomized, 4-way Crossover Study to Evaluate Short-term Safety, Tolerability and Pharmacokinetics of the Co-administration of TMC435 and GSK2336805 at Steady-state (Part 2), in Healthy Japanese Subjects

Janssen R&D Ireland0 个研究点目标入组 48 人开始时间: 2013年10月最近更新: 2014年6月17日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 48
主要终点: Part 1: Area under the plasma concentration-time curve of GSK2336805

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of the study is to investigate the safety, tolerability, and pharmacokinetic (what the body does to a medication) of GSK2336805 alone and with the co-administration of TMC435 in healthy Japanese participants.

详细描述

This study will consists of 2 parts (Part 1 and 2) which will be sequentially conducted in 2 separate panels of 24 healthy adult Japanese participants each, at a single center. Part 1 is a double-blind (neither physician nor participant knows the treatment that the participant receives), placebo-controlled (placebo is compared with the study medication to test whether the study medication has a real effect in clinical study), randomized (study medication is assigned by chance), single ascending dose study to investigate the safety, tolerability, and pharmacokinetics of GSK2336805 in participants. It will consist of a screening phase, a treatment phase, and a follow-up phase. The maximum study duration for each participant will be approximately 5 weeks (including screening and follow-up phase). 24 participants will be equally divided in 3 cohorts with 8 participants in each cohort. In each cohort, participants will be randomly assigned to receive either a single oral dose of GSK2336805 (6 participants) or placebo (2 participants). Part 2 is an open-label (all people know the identity of the intervention), randomized, 4-way crossover study (method used to switch patients from one treatment arm to another in a clinical study) to investigate the potential pharmacokinetic drug-drug interactions between TMC435 and GSK2336805 at steady-state, and to evaluate the short-term safety and tolerability when TMC435 and GSK2336805 are co-administered in participants. It will consist of a screening phase, a treatment phase (4 treatment sessions [Treatment A, B, C, and D]), and a follow-up phase. The maximum study duration for each participant will be approximately 12 weeks (including screening and follow-up phase). During 4 treatment sessions, each of the 24 participants will receive Treatment A, B, C and D consecutively in different sequences with a washout period of at least 7 days between consecutive treatment sessions in each individual participant. Safety will be evaluated by assessing adverse events, clinical laboratory tests, electrocardiogram, vital signs, physical examination, alcohol breath tests, and specific toxicities.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Treatment
盲法: Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围: 20 Years 至 55 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Healthy Japanese participants on the basis of medical history, physical examination, vital signs, triplicate 12-lead electrocardiogram, and clinical laboratory testing performed at screening
•Must have signed an Informed Consent Form (ICF) indicating they understand the purpose of and procedures required for the study
•Must be willing to adhere to the prohibitions and restrictions specified in the protocol
•Women must be of non-childbearing potential (postmenopausal for at least 2 years or surgically sterile)
•Women, except for postmenopausal women, should have a negative serum b-human chorionic gonadotropin (hCG) pregnancy test at screening

排除标准

•History or evidence of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use within the past one year
•Participants with hepatitis A, B, or C infection or human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection at study screening
•Female participants who are breastfeeding at screening
•History of liver or renal impairment; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, neoplastic, or metabolic disturbances
•Participants with known allergies, hypersensitivity, or intolerance to GSK2336805, TMC435 or excipients of the drug products used

研究组 & 干预措施

Part 1, Cohort A

Experimental

8 participants to receive a single oral dose of 30 mg of GSK2336805 (6 participants) or placebo (2 participants) on Day 1.

干预措施: GSK2336805 30 mg (Drug)

Part 1, Cohort B

Experimental

8 participants to receive a single oral dose of 60 mg of GSK2336805 (6 participants) or placebo (2 participants) on Day 1.

干预措施: GSK2336805 60 mg (Drug)

Part 1, Cohort C

Experimental

8 participants to receive a single oral dose of 120 mg of GSK2336805 (6 participants) or placebo (2 participants) on Day 1.

干预措施: GSK2336805 120 mg (Drug)

Part 2, Sequence 1

Experimental

6 participants to receive Treatment A (TMC435 150 mg), D (TMC435 150 mg+GSK2336805 60 mg), B (GSK2336805 60 mg), and C (TMC435 100 mg+GSK2336805 60 mg) in a sequence with a 7 days washout period between each treatment sessions.

干预措施: TMC435 150 mg (Treatment A) (Drug)

Part 2, Sequence 1

Experimental

干预措施: GSK2336805 60 mg (Treatment B and part of Treatment C and D) (Drug)

Part 2, Sequence 1

Experimental

干预措施: TMC435 100 mg (part of Treatment C) (Drug)

Part 2, Sequence 1

Experimental

干预措施: TMC435 150 mg (part of treatment D) (Drug)

Part 2, Sequence 2

Experimental

6 participants to receive Treatment B (GSK2336805 60 mg), A (TMC435 150 mg), C (TMC435 100 mg+GSK2336805 60 mg), and D (TMC435 150 mg+GSK2336805 60 mg) in a sequence with a 7 days washout period between each treatment sessions.

干预措施: TMC435 150 mg (Treatment A) (Drug)

Part 2, Sequence 2

Experimental

干预措施: GSK2336805 60 mg (Treatment B and part of Treatment C and D) (Drug)

Part 2, Sequence 2

Experimental

干预措施: TMC435 100 mg (part of Treatment C) (Drug)

Part 2, Sequence 2

Experimental

干预措施: TMC435 150 mg (part of treatment D) (Drug)

Part 2, Sequence 3

Experimental

6 participants to receive Treatment C (TMC435 100 mg+GSK2336805 60 mg), B (GSK2336805 60 mg), D (TMC435 150 mg+GSK2336805 60 mg), and A (TMC435 150 mg) in a sequence with a 7 days washout period between each treatment sessions.

干预措施: TMC435 150 mg (Treatment A) (Drug)

Part 2, Sequence 3

Experimental

干预措施: GSK2336805 60 mg (Treatment B and part of Treatment C and D) (Drug)

Part 2, Sequence 3

Experimental

干预措施: TMC435 100 mg (part of Treatment C) (Drug)

Part 2, Sequence 3

Experimental

干预措施: TMC435 150 mg (part of treatment D) (Drug)

Part 2, Sequence 4

Experimental

6 participants to receive Treatment D (TMC435 150 mg+GSK2336805 60 mg), C (TMC435 100 mg+GSK2336805 60 mg), A (TMC435 150 mg) and B (GSK2336805 60 mg) in a sequence with a 7 days washout period between each treatment sessions.

干预措施: TMC435 150 mg (Treatment A) (Drug)

Part 2, Sequence 4

Experimental

干预措施: GSK2336805 60 mg (Treatment B and part of Treatment C and D) (Drug)

Part 2, Sequence 4

Experimental

干预措施: TMC435 100 mg (part of Treatment C) (Drug)

Part 2, Sequence 4

Experimental

干预措施: TMC435 150 mg (part of treatment D) (Drug)

结局指标

主要结局

Part 1: Area under the plasma concentration-time curve of GSK2336805

时间窗: Predose, postdose on Day 1 (0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16 hours), Day 2 (24 and 36 hour), Day 3, and time point of early withdrawal

Part 1: Maximum observed plasma concentration of GSK2336805

时间窗: Predose, postdose on Day 1 (0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16 hours), Day 2 (24 and 36 hour), Day 3, and time point of early withdrawal

Part 1: The actual sampling time to reach the maximum observed plasma concentration of GSK2336805

时间窗: Predose, postdose on Day 1 (0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16 hours), Day 2 (24 and 36 hour), Day 3, and time point of early withdrawal

Part 2: The actual sampling time to reach the maximum observed plasma concentration of TMC435

时间窗: Predose, postdose on Day 1 (0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours), Day 2, Day 5, Day 6, Day 7 (predose and postdose (0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours), Day 8, Day 9, Day 10, and time point of early withdrawal

Part 2: Maximum observed plasma concentration of GSK2336805

Part 2: Area under the plasma concentration-time curve of GSK2336805

Part 2: The actual sampling time to reach the maximum observed plasma concentration of GSK2336805

Part 2: Maximum observed plasma concentration of TMC435

Part 2: Area under the plasma concentration-time curve of TMC435

次要结局

Part 1 and 2: Number of participants with adverse events(Up to 12-14 weeks)

研究者

发起方

Janssen R&D Ireland

申办方类型

Industry

责任方

Sponsor

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