Healthy Volunteers Clinical Trial
Official title:
A Phase 1 Study of Oral TAK-788 to Evaluate the Drug-Drug Interaction With Itraconazole and Rifampin in Healthy Adult Subjects
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.
The drug being tested in this study is called TAK-788 (Mobocertinib). The study assessed 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 enrolled 24 healthy participants. The study was designed to consist of 2 parts:
Part 1- TAK-788 assessment with itraconazole Part 2- TAK-788 assessment with rifampin. Part 1
had 2 cohorts:
Part 1: Participants (n = 12) received 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 were coadmistered on Day 5
of Period 2.
In Part 2 participants (n = 12) received a single oral 160 mg dose of TAK-788 capsules in
Period 1 of Day 1 followed by 600 mg capsules of rifampin QD in Period 2 Days 1 to Day 13 and
a single dose of 160 mg TAK-788 capsules was coadministered on Day 7 of Period 1. There was 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 was conducted in the United States. The overall time to participate
in this study was approximately 120 days (including screening period). Participants were
contacted by telephone 30 days after the last dose of study drug for a follow-up assessment.
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