NCT03161405

A Study to Evaluate the Effect of the Potent CYP3A4 Inhibitor Itraconazole on the Pharmacokinetics (PK) of TAK-906 in Healthy Participants

A Single-Sequence, Open-Label, 2-Period, Crossover Trial to Evaluate the Effect of the Potent CYP3A4 Inhibitor Itraconazole on the Single-Dose Pharmacokinetics of Oral TAK-906 in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the effect of the potent cytochrome P-450 (CYP) 3A4 inhibitor (itraconazole) on the single-dose PK of oral TAK-906 maleate.

Detailed description

The drug being tested in this study is called TAK-906. TAK-906 is being tested in healthy participants in order to evaluate the effect of the potent CYP3A4 inhibitor itraconazole on the single-dose PK of TAK-906 maleate. The study enrolled 12 participants. Participants received the following treatment sequence: • TAK-906 maleate 25 mg; Itraconazole 200 mg + TAK-906 maleate 25 mg Participants were given an oral dose of TAK-906 in the First Intervention Period which was followed by a washout period, after which participants were given Itraconazole solution along with TAK-906 orally in the Second Intervention Period. This single center trial was conducted in the United States. The overall duration to participate in this study was 7 weeks. Participants remained confined in the clinic from Day 1 up to Day 2 (First Intervention Period) and Day 4 up Day 6 (Second Intervention Period). Participants returned for a Follow-up Visit, 10 to 14 days after last dose of study drug.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	TAK-906 Maleate	TAK-906 capsule
DRUG	Itraconazole	Itraconazole solution

Timeline

• Start date: 2017-06-05
• Primary completion: 2017-07-02
• Completion: 2017-07-10
• First posted: 2017-05-19
• Last updated: 2019-01-11
• Results posted: 2019-01-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study