Last updated on May 2019

A Study to Evaluate Drug-Drug Interaction of TAK-788 With Itraconazole and Rifampin in Healthy Adult Participants


Brief description of study

The purpose of this study is to characterize the effect of itraconazole (Part 1) and rifampin (Part 2) on the single-dose pharmacokinetics (PK) of TAK-788 and its active metabolites (AP32960 and AP32914) in healthy adult participants.

Detailed Study Description

The drug being tested in this study is called TAK-788. The study will assess the drug-drug interaction of TAK-788 with either a strong cytochrome P-450 (CYP)3A inhibitor, itraconazole (Part 1) or with a strong CYP3A inducer, rifampin (Part 2) in healthy adult participants.

The study will enroll approximately 28 healthy participants. The study is designed to consist of 2 parts: Part 1- TAK-788 assessment with itraconazole Part 2- TAK-788 assessment with rifampin. Part 1 will have 2 cohorts:

Cohort 1: Participants will receive a single oral dose of 20 mg capsule of TAK-788 on Day 1 of Period 1 followed by 200 mg itraconazole oral solution once daily (QD) in Period 2 on Days 1 to Day 14 and a single oral dose of TAK-788 20 mg capsule will be coadmistered on Day 5 of Period 2.

Cohort 2: Participants will receive a single oral to be decided (TBD) dose of TAK-788 in Period 1 on Day 1 followed by 200 mg itraconazole oral solution QD in Period 2 on Days 1 to 14 and a single oral TBD dose of TAK-788 will be coadministered on Day 5 of Period 2.

In Part 2 participants will receive a single oral 4x40 mg (160 mg) dose of TAK-788 capsules in Period 1 of Day 1 followed by 2x300 mg (600 mg) capsules of rifampin QD in Period 2 Days 1 to Day 13 and a single dose of 4x40 mg (160 mg) TAK-788 capsules will be coadministered on Day 7 of Period 1. There will be a washout period of 7 days between the dose of TAK-788 on Period 1 and the first dose of rifampin in Period 2.

This single-center trial will be conducted in the United States. The overall time to participate in this study is approximately 120 days. Participants will be contacted by telephone 30 days after the last dose of study drug for a follow-up assessment.

Clinical Study Identifier: NCT03928327

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Celerion

Tempe, AZ United States
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Recruitment Status: Open


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