NCT02448719

Single-Dose Phase 1 Study of TAK-792

A Randomized, Single-Center, Double-Blind, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Oral Dose of TAK-792 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Takeda · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study will be double-blind and placebo-controlled to avoid subjective bias in the assessment of safety and tolerability of TAK-792. Sentinel dosing will be used in the first cohort (cohort 1) to ensure adequate safety and tolerability evaluation prior to administering TAK-792 to the remainder of participants within the cohort. The dose escalation to the next cohort for Cohorts 2 to 6 will occur after full review of safety and tolerability of the current cohort, and available pharmacokinetic data up to 24 hours in the preceding cohorts. The planned dose levels are 30, 100, 250, 500, 750 and 1250 mg, to be administered in the morning after a fast of at least 10 hours.

Conditions

• Healthy Male Adults Participants

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-05-27
• Primary completion: 2016-01-28
• Completion: 2016-01-28
• First posted: 2015-05-19
• Last updated: 2019-03-19
• Results posted: 2019-02-15

Locations

1 site across 1 country: Japan