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

NCT02286518 | Completed Phase 1 Results

• 3 other identifiers: TAK-114/CPH-001U1111-1162-6078JapicCTI-142691
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Clinical Pharmacology

Outcome Measures

Primary Outcomes (6)

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

  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

  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

  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.

  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)

  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

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

Secondary Outcomes (7)

• Cmax - Maximum Observed Plasma Concentration for TAK-114

  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

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

  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

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

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

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

  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

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

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

Study Arms (15)

Cohort 1A: TAK-114 10 mg

EXPERIMENTAL

Orally, once only.

Drug: TAK-114 10 mg capsule

Cohort 1B: TAK-114 10 mg

EXPERIMENTAL

Orally, once

Drug: TAK-114 10 mg capsule

Cohort 2A: TAK-114 20 mg

EXPERIMENTAL

Orally, once

Drug: TAK-114 10 mg capsule

Cohort 2B: TAK-114 20 mg

EXPERIMENTAL

Orally, once

Drug: TAK-114 10 mg capsule

Cohort 3A: TAK-114 50 mg

EXPERIMENTAL

Orally, once

Drug: TAK-114 10 mg capsule

Cohort 3B: TAK-114 50 mg

EXPERIMENTAL

Orally, once

Drug: TAK-114 10 mg capsule

Cohort 4a: TAK-114 20 mg

EXPERIMENTAL

Period 1: Single-dose administration in a fasting state Period 2: Single-dose administration 30 minutes after breakfast

Drug: TAK-114 10 mg capsule

Cohort 4b: TAK-114 20 mg

EXPERIMENTAL

Period 1: Single-dose administration 30 minutes after breakfast Period 2: Single-dose administration in a fasting state

Drug: TAK-114 10 mg capsule

Cohort 5A: TAK-114 20 mg

EXPERIMENTAL

Orally, Twice daily, 10 days

Drug: TAK-114 10 mg capsule

Cohort 5B: TAK-114 20 mg

EXPERIMENTAL

Orally, Twice daily, 10 days

Drug: TAK-114 10 mg capsule

Cohort 6A: TAK-114 50 mg

EXPERIMENTAL

Orally, Twice daily, 10 days

Drug: TAK-114 10 mg capsule

Cohort 6B: TAK-114 50 mg

EXPERIMENTAL

Orally, Twice daily, 10 days

Drug: TAK-114 10 mg capsule

Cohort 1A, 2A, 3A: TAK-114 placebo

PLACEBO COMPARATOR

Cohort 1A, 2A, 3A: Orally, once

Drug: TAK-114 matched placebo

Cohort 5A: TAK-114 placebo

PLACEBO COMPARATOR

Cohort 5A: Orally, Twice daily, 10 days

Drug: TAK-114 matched placebo

Cohort 6A: TAK-114 placebo

PLACEBO COMPARATOR

Cohort 6A: Orally, Twice daily, 10 days

Drug: TAK-114 matched placebo

Interventions

TAK-114 10 mg capsule DRUG

Cohort 1A: TAK-114 10 mg; Cohort 1B: TAK-114 10 mg; Cohort 2A: TAK-114 20 mg; Cohort 2B: TAK-114 20 mg; Cohort 3A: TAK-114 50 mg; Cohort 3B: TAK-114 50 mg; Cohort 4a: TAK-114 20 mg; Cohort 4b: TAK-114 20 mg; Cohort 5A: TAK-114 20 mg; Cohort 5B: TAK-114 20 mg; Cohort 6A: TAK-114 50 mg; Cohort 6B: TAK-114 50 mg

TAK-114 matched placebo DRUG

Cohort 1A, 2A, 3A: TAK-114 placebo; Cohort 5A: TAK-114 placebo; Cohort 6A: TAK-114 placebo

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Unknown Facility

Sumida-ku, Tokyo, Japan

Location

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• General Manager

  Takeda

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2014
• First Posted: November 7, 2014
• Study Start: November 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: July 25, 2016
• Results First Posted: July 25, 2016

Record last verified: 2016-06

Locations

JP (1)