临床试验/NCT03482453

NCT03482453已完成1 期

Phase 1, Randomized, Double-blind, Placebo-Controlled, Single Rising Dose Study to Evaluate Pharmacokinetics, Safety, and Tolerability of TAK-788 Followed by Open-Label, Crossover Evaluation of the Effects of a Low-Fat Meal on TAK-788 Pharmacokinetics and Evaluation of Relative Bioavailability of TAK-788 Capsules in Healthy Subjects

Millennium Pharmaceuticals, Inc.1 个研究点分布在 1 个国家目标入组 69 人开始时间: 2018年3月28日最近更新: 2020年1月29日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Millennium Pharmaceuticals, Inc.
入组人数: 69
试验地点: 1
主要终点: Part 1: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)

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研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to assess the safety, tolerability of TAK-788 and to identify a tolerable single oral dose of TAK-788 administered as a drug-in-capsule (DiC) formulation, to characterize the effects of a low-fat meal on the PK of the TAK-788 administered as DiC formulation and to evaluate the bioavailability of a test (Process B) DiC of TAK-788 relative to a reference (Process A) DiC of TAK-788 in healthy participants.

详细描述

The drug being tested in this study is called TAK-788. The study will assess the safety and tolerability of single oral dose of TAK-788, evaluate the effect of a low-fat meal on PK of TAK-788 and will assess the relative bioavailability of two DiCs of TAK-788.

The study will enroll approximately 69 participants. The study is designed to consist of 3 parts: Part 1- dose escalation phase, Part 2- low fat meal effect and Part 3 - relative bioavailability. The study population of Part 1 will consist of 40 participants enrolled into 5 cohorts. Each cohort will have 8 randomized participants with 6 receiving a single dose of TAK-788, and 2 receiving matching placebo under fasted conditions. In Cohorts 1 to 5, safety of single-dose TAK-788 will be evaluated. For Part 2, the effect of a low-fat meal on a single tolerable dose of TAK-788 will be determined following review of safety and tolerability data from the previous cohorts in Part 1. The study population of Part 2 will consist of 16 participants enrolled into 2 cohorts of different doses, where participants will be randomized to a cross-over sequence of:

TAK-788 Fed + TAK-788 Fasted
TAK-788 Fasted + TAK-788 Fed

The study population of Part 3 will consist of 13 participants enrolled into 1 cohort, where participants will be randomized to a cross-over sequence of:

TAK-788 DiC (reference) + TAK-788 DiC (test)
TAK-788 DiC (test) + TAK-788 DiC (reference) This single-center trial will be conducted in the United States. The overall time to participate in this study is approximately 7 months. Participants will be contacted by telephone 30 days after the last dose of study drug for a follow-up assessment.

研究设计

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

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 weight of greater than or equal to (>=) 45 kilogram (kg) (women) or >=55 kg (men) and a body mass index of 18.0 to 30.0 kilogram per square meter (kg/m^2) at screening.
•Nonsmoker (never smoked or greater than [>] 20 years from last occurrence of smoking).
•Normal organ function including hepatic, renal, and bone marrow function.

排除标准

•Manifestations of malabsorption due to prior gastro-intestinal (GI) surgery, GI disease, or for an unknown other reason that may alter the PK of TAK-
•Pulmonary infection ongoing or within 30 days of informed consent.
•Inability to undergo venipuncture and/or tolerate venous access.
•Inability to tolerate multiple blood sampling.
•Ongoing or active infection, including but not limited to, the requirement for intravenous (IV) antibiotics.

研究组 & 干预措施

Part 1 Cohort 2: TAK-788

Experimental

TAK-788, capsule, orally or TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1 following review of safety data from Cohort 1.

干预措施: Placebo (Drug)

Part 1 Cohort 1: TAK-788

Experimental

TAK-788, capsule, orally or TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1.

干预措施: TAK-788 (Drug)

Part 1 Cohort 1: TAK-788

Experimental

TAK-788, capsule, orally or TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1.

干预措施: Placebo (Drug)

Part 1 Cohort 2: TAK-788

Experimental

TAK-788, capsule, orally or TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1 following review of safety data from Cohort 1.

干预措施: TAK-788 (Drug)

Part 1 Cohort 3: TAK-788

Experimental

TAK-788, capsule, orally or TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1 following review of safety data from Cohort 2.

干预措施: TAK-788 (Drug)

Part 1 Cohort 3: TAK-788

Experimental

TAK-788, capsule, orally or TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1 following review of safety data from Cohort 2.

干预措施: Placebo (Drug)

Part 1 Cohort 4: TAK-788

Experimental

TAK-788, capsule, orally or TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1 following review of safety data from Cohort 3.

干预措施: TAK-788 (Drug)

Part 1 Cohort 4: TAK-788

Experimental

TAK-788, capsule, orally or TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1 following review of safety data from Cohort 3.

干预措施: Placebo (Drug)

Part 1 Cohort 5: TAK-788

Experimental

TAK-788, capsule, orally or TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1 following review of safety data from Cohort 4.

干预措施: TAK-788 (Drug)

Part 1 Cohort 5: TAK-788

Experimental

TAK-788, capsule, orally or TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1 following review of safety data from Cohort 4.

干预措施: Placebo (Drug)

Part 2: TAK-788 Fed + TAK-788 Fasted

Experimental

TAK-788, capsule, orally, once on Day 1 of Intervention Period 1 under fed conditions with low-fat meal (Treatment A), followed by at least 7 days washout period, further followed by TAK-788, capsule, orally, once on Day 1 of Intervention Period 2 under fasted conditions (Treatment B). TAK-788 dose will be determined based on review of safety and tolerability data from cohorts of Part 1.

干预措施: TAK-788 (Drug)

Part 2: TAK-788 Fasted + TAK-788 Fed

Experimental

TAK-788, capsule, orally, once on Day 1 of Intervention Period 1 under fasted conditions (Treatment B), followed by at least 7 days washout period, further followed by TAK-788, capsule, orally, once on Day 1 of Intervention Period 2 under fed conditions with low-fat meal (Treatment A). TAK-788 dose will be determined based on review of safety and tolerability data from cohorts of Part 1.

干预措施: TAK-788 (Drug)

Part 3: TAK-788 DiC (reference) + TAK-788 DiC (test)

Experimental

TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 1, followed by at least 7 days washout period, further followed by TAK-788 160 mg, DiC B (test), orally, under fasted condition, once on Day 1 of Intervention Period 2.

干预措施: TAK-788 (Drug)

Part 3: TAK-788 DiC (test) + TAK-788 DiC (reference)

Experimental

TAK-788 160 mg, DiC B (test), orally, under fasted condition, once, on Day 1 of Intervention Period 1, followed by at least 7 days washout period, further followed by TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 2.

干预措施: TAK-788 (Drug)

结局指标

主要结局

Part 1: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)

时间窗: Baseline up to 30 days after the last dose of study drug (Day 31)

Part 1: Number of Participants With One or More Serious Adverse Events (SAEs)

时间窗: Baseline up to 30 days after the last dose of study drug (Day 31)

Part 1: Number of Participants With Clinically Significant Abnormal Laboratory Values

时间窗: Baseline up to 30 days after the last dose of study drug (Day 31)

Part 2, Cmax: Maximum Observed Plasma Concentration for TAK-788