Single-Dose Phase 1 Study of TAK-792

Summary

The purpose of this study is to characterize the safety and tolerability profile of TAK-792 when administered as a single oral dose in healthy Japanese and Caucasian male participants.

Conditions

• Healthy Male Adults Participants

Interventions

DRUG

TAK-792 30 mg

TAK-792 30 mg was administered in the morning after a fast.

DRUG

TAK-792 30 mg placebo

TAK-792 30 mg placebo was administered in the morning after a fast.

DRUG

TAK-792 100 mg

TAK-792 100 mg was administered in the morning after a fast.

DRUG

TAK-792 100 mg placebo

TAK-792 100 mg placebo was administered in the morning after a fast.

DRUG

TAK-792 250 mg

TAK-792 250 mg was administered in the morning after a fast.

DRUG

TAK-792 250 mg placebo

TAK-792 250 mg placebo was administered in the morning after a fast.

DRUG

TAK-792 500 mg

TAK-792 500 mg was administered in the morning after a fast or after breakfast.

DRUG

TAK-792 500 mg placebo

TAK-792 500 mg placebo was administered in the morning after a fast or after breakfast.

DRUG

TAK-792 750 mg

TAK-792 750 mg was administered in the morning after a fast.

DRUG

TAK-792 750 mg placebo

TAK-792 750 mg placebo was administered in the morning after a fast.

DRUG

TAK-792 1250 mg

TAK-792 1250 mg was administered in the morning after a fast.

DRUG

TAK-792 1250 mg placebo

TAK-792 1250 mg placebo was administered in the morning after a fast.

Sponsors & Collaborators

• Takeda

  lead INDUSTRY

Principal Investigators

• Medical Director · Takeda

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

45 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-05-27

Primary Completion

2016-01-28

Completion

2016-01-28

Countries

• Japan

Study Locations