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Completed

NCT Number: NCT02286518

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

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.

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Key information

Conditions

Clinical Pharmacology

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Sumida-ku, Tokyo, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TAK-114 10 mg capsule

Drug

TAK-114 matched placebo

Drug

Primary outcomes

  1. 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)

  2. 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

  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

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

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

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

  5. 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

  6. 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

  1. 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

  2. AUC (0-Infinity) - Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for Unchanged TAK-114: Part 1 and Part 2

    Time frame: 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

  3. AUC (0-tau) - Area Under the Plasma Concentration-Time Curve From Time 0 to Time Tau for TAK-114: Part 3

    Time frame: Day10: predose and at multiple time points (up to 12 hours) postdose for Part 3

  4. Mean Terminal Phase Elimination Half-life (T1/2) for TAK-114

    Time frame: 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

  5. Mean R(Cmax): Mean Accumulation Coefficient of Observed Maximum Plasma Concentration for TAK-114: Part 3

    Time frame: Days 1 and 10: predose and at multiple time points (up to 12 hours) postdose for Part 3

    Mean R(Cmax) was estimated as the ratio of Cmax on Day 10 and Cmax on Day 1. Cmax is the peak plasma drug concentration of TAK-114.

  6. 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

    Time frame: Days 1 and 10: predose and at multiple time points (up to 12 hours) postdose for Part 3

    Mean R(AUC) was estimated as the ratio of AUC(0-tau) on Day 10 and AUC(0-tau) on Day 1. AUC (0-tau) is the area under the plasma concentration-time curve from time 0 to time tau.

  7. Urinary Excretion Ratio of TAK-114 From 0 to 48 Hours Postdose: Part 1

    Time frame: Day 1: 0 to 48 hours postdose

    Urinary excretion ratio (% of dose) of TAK-114 in urine were calculated for each participant. Ratio was calculated from the urine concentrations of each analyte and the volume of urine collected.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 7, 2014
Registry last updated
Jul 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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