TAK-114 Single- and Multiple-Dose Phase 1 Study

Takeda82 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Clinical Pharmacology

Interventions

TAK-114 10 mg capsuleDRUG

TAK-114 matched placeboDRUG

Eligibility

Sex: MALEMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

Sumida-ku, Tokyo, Japan

Outcomes

Primary Outcomes

Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)

Time frame: 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)

Number of Participants With TEAEs Related to Vital Signs

Time frame: Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3

Number of Participants With TEAEs Related to Body Weight

Time frame: Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3

Number of Participants With Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG)

Number of participants who had ECG shifts from "within normal limit" at baseline to "abnormal, clinically significant" after study drug administration were reported.

Time frame: Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3

Number of Participants With Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG)

Time frame: Baseline up to Day 2 (only for Cohorts 1A, 2A, and 3A) in Part 1

Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis

Time frame: Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3

Secondary Outcomes

Cmax - Maximum Observed Plasma Concentration for TAK-114

Time frame: 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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.