Clinical trial NCT02286518: TAK-114 Single- and Multiple-Dose Phase 1 Study
Official title: A Single-center, Single- and Multiple-Dose Phase 1 Study to Evaluate the Safety and Pharmacokinetics of TAK-114 in Healthy Adult Japanese and Caucasian Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Clinical Pharmacology
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2014-11-07
Enrollment: 82
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and tolerability of TAK-114 following single and multiple ascending oral doses in healthy Japanese male participants.

Detailed description: This is a phase 1, randomized, double-blind, placebo-controlled, single and multiple oral dose study in healthy Caucasian and Japanese male participants.

The study is composed of three parts, Single-dose Ascending Part, Food Effect Part and Multiple-dose Ascending Part. Single-dose Ascending Part and Multiple-dose Ascending Part are designed as a randomized, double-blind or open-label, placebo-controlled, sequential-cohort, ascending single or multiple oral dose study of TAK-114 or matched placebo. The Food Effect Part is designed as a randomized, open-label, 2-period crossover study of a single dose of TAK-114.

Eligibility criteria: Inclusion Criteria:

Healthy Japanese participants:

* Must be willing to provide written informed consent and in the investigator's opinion able to comply with the study protocol.
* Is aged 20 to 45 years, inclusive.
* Weighs at least 50 kilogram (kg) and have a body mass index (BMI) between 18.5 and 25.0 kilogram per square meter (kg/m\^2).

Healthy Caucasian participants:

* Must be willing to provide written informed consent and in the investigator's opinion able to comply with the study protocol.
* Is aged 20 to 45 years, inclusive; are of Caucasian descent (born to Caucasian parents and grandparents and has lived outside original country for less than 5 years) and maintains their original diet and lifestyle.
* Weighs at least 50 kg and have a body mass index between 18.5 and 30.0 kg/m2.

Exclusion Criteria:

• Participants have a known hypersensitivity to any component of the formulation of TAK-114 or any herb medicine or supplement related to Indigo naturalis.

Primary outcomes:
measure: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)
timeFrame: Baseline up to 3 days after the last dose of study drug (Day 3 in Part 1), (Day 20 in Part 2) and 7 days after the last dose of study drug (Day 17 in Part 3)
measure: Number of Participants With TEAEs Related to Vital Signs
timeFrame: Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3
measure: Number of Participants With TEAEs Related to Body Weight
timeFrame: Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3
measure: Number of Participants With Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG)
timeFrame: Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3
measure: Number of Participants With Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG)
timeFrame: Baseline up to Day 2 (only for Cohorts 1A, 2A, and 3A) in Part 1
measure: Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis
timeFrame: Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3
Secondary outcomes:
measure: Cmax - Maximum Observed Plasma Concentration for TAK-114
timeFrame: Day1: predose and at multiple time-points (up to 48 hours) postdose for Part 1; Day 1:predose and at multiple time-points (up to 48 hours) postdose in each period for Part 2; Day 10:predose and at multiple time points (up to 12 hours) postdose for Part 3
measure: AUC (0-Infinity) - Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for Unchanged TAK-114: Part 1 and Part 2
timeFrame: Day 1: predose and at multiple time-points (up to 48 hours) postdose for Part 1; Day 1: predose and at multiple time-points (up to 48 hours) postdose in each period for Part 2
measure: AUC (0-tau) - Area Under the Plasma Concentration-Time Curve From Time 0 to Time Tau for TAK-114: Part 3
timeFrame: Day10: predose and at multiple time points (up to 12 hours) postdose for Part 3
measure: Mean Terminal Phase Elimination Half-life (T1/2) for TAK-114
timeFrame: Day1:predose and at multiple time-points (up to 48 hours) postdose for Part 1; Day1:predose and at multiple time-points (up to 48 hours) postdose in each period for Part 2; Day 10: predose and at multiple time points (up to 12 hours) postdose for Part 3
measure: Mean R(Cmax): Mean Accumulation Coefficient of Observed Maximum Plasma Concentration for TAK-114: Part 3
timeFrame: Days 1 and 10: predose and at multiple time points (up to 12 hours) postdose for Part 3
measure: Mean R(AUC): Mean of Accumulation Coefficient of Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-114: Part 3
timeFrame: Days 1 and 10: predose and at multiple time points (up to 12 hours) postdose for Part 3
measure: Urinary Excretion Ratio of TAK-114 From 0 to 48 Hours Postdose: Part 1
timeFrame: Day 1: 0 to 48 hours postdose
Other outcomes:
Locations:
city: Sumida-ku
country: Japan
state: Tokyo
Study officials:
affiliation: Takeda
name: General Manager
role: STUDY_CHAIR
References: