Clinical trial NCT02448719
Conditions: Healthy Male Adults Participants
Sponsor: Takeda
Start date: 2015-05-27; Completion date: 2016-01-28
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Arms: arm 1: Single oral administration of TAK-792 30 milligram (mg) in Japanese participants arm 2: Single oral administration of TAK-792 30 mg placebo in Japanese participants arm 3: Single oral administration of TAK-792 100 mg in Japanese participants arm 4: Single oral administration of TAK-792 100 mg placebo in Japanese participants arm 5: Single oral administration of TAK-792 250 mg in Japanese participants arm 6: Single oral administration of TAK-792 250 mg placebo in Japanese participants arm 7: Single oral administration of TAK-792 500 mg in Japanese and Caucasian participants arm 8: Single oral administration of TAK-792 500 mg placebo in Japanese and Caucasian participants arm 9: Single oral administration of TAK-792 750 mg in Japanese and Caucasian participants arm 10: Single oral administration of TAK-792 750 mg placebo in Japanese and Caucasian participants arm 11: Single oral administration of TAK-792 1250 mg in Japanese and Caucasian participants arm 12: Single oral administration of TAK-792 1250 mg placebo in Japanese and Caucasian participants
Interventions: intervention 1: TAK-792 30 mg intervention 2: TAK-792 30 mg placebo intervention 3: TAK-792 100 mg intervention 4: TAK-792 100 mg placebo intervention 5: TAK-792 250 mg intervention 6: TAK-792 250 mg placebo intervention 7: TAK-792 500 mg intervention 8: TAK-792 500 mg placebo intervention 9: TAK-792 750 mg intervention 10: TAK-792 750 mg placebo intervention 11: TAK-792 1250 mg intervention 12: TAK-792 1250 mg placebo
Intervention descriptions: intervention 1: TAK-792 30 mg was administered in the morning after a fast. intervention 2: TAK-792 30 mg placebo was administered in the morning after a fast. intervention 3: TAK-792 100 mg was administered in the morning after a fast. intervention 4: TAK-792 100 mg placebo was administered in the morning after a fast. intervention 5: TAK-792 250 mg was administered in the morning after a fast. intervention 6: TAK-792 250 mg placebo was administered in the morning after a fast. intervention 7: TAK-792 500 mg was administered in the morning after a fast or after breakfast. intervention 8: TAK-792 500 mg placebo was administered in the morning after a fast or after breakfast. intervention 9: TAK-792 750 mg was administered in the morning after a fast. intervention 10: TAK-792 750 mg placebo was administered in the morning after a fast. intervention 11: TAK-792 1250 mg was administered in the morning after a fast. intervention 12: TAK-792 1250 mg placebo was administered in the morning after a fast.

Protocol documents: