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

Takeda

Status and phase: Completed; Phase 1

Conditions: Clinical Pharmacology

Treatments: Drug: TAK-114 10 mg capsule; Drug: TAK-114 matched placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02286518

U1111-1162-6078 (Registry Identifier)

JapicCTI-142691 (Registry Identifier)

TAK-114/CPH-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 82 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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82 participants in 15 patient groups, including a placebo group

Cohort 1A: TAK-114 10 mg

Experimental group

Description:

Orally, once only.

Treatment:

Drug: TAK-114 10 mg capsule

Cohort 1B: TAK-114 10 mg

Experimental group

Description:

Orally, once

Treatment:

Drug: TAK-114 10 mg capsule

Cohort 2A: TAK-114 20 mg

Experimental group

Description:

Orally, once

Treatment:

Drug: TAK-114 10 mg capsule

Cohort 2B: TAK-114 20 mg

Experimental group

Description:

Orally, once

Treatment:

Drug: TAK-114 10 mg capsule

Cohort 3A: TAK-114 50 mg

Experimental group

Description:

Orally, once

Treatment:

Drug: TAK-114 10 mg capsule

Cohort 3B: TAK-114 50 mg

Experimental group

Description:

Orally, once

Treatment:

Drug: TAK-114 10 mg capsule

Cohort 4a: TAK-114 20 mg

Experimental group

Description:

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

Treatment:

Drug: TAK-114 10 mg capsule

Cohort 4b: TAK-114 20 mg

Experimental group

Description:

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

Treatment:

Drug: TAK-114 10 mg capsule

Cohort 5A: TAK-114 20 mg

Experimental group

Description:

Orally, Twice daily, 10 days

Treatment:

Drug: TAK-114 10 mg capsule

Cohort 5B: TAK-114 20 mg

Experimental group

Description:

Orally, Twice daily, 10 days

Treatment:

Drug: TAK-114 10 mg capsule

Cohort 6A: TAK-114 50 mg

Experimental group

Description:

Orally, Twice daily, 10 days

Treatment:

Drug: TAK-114 10 mg capsule

Cohort 6B: TAK-114 50 mg

Experimental group

Description:

Orally, Twice daily, 10 days

Treatment:

Drug: TAK-114 10 mg capsule

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

Placebo Comparator group

Description:

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

Treatment:

Drug: TAK-114 matched placebo

Cohort 5A: TAK-114 placebo

Placebo Comparator group

Description:

Cohort 5A: Orally, Twice daily, 10 days

Treatment:

Drug: TAK-114 matched placebo

Cohort 6A: TAK-114 placebo

Placebo Comparator group

Description:

Cohort 6A: Orally, Twice daily, 10 days

Treatment:

Drug: TAK-114 matched placebo