NCT03849690

A Trial to Evaluate the Effect of the Proton Pump Inhibitor Esomeprazole on the Single-dose Pharmacokinetics (PK) of Oral TAK-906 in Healthy Adult Participants

A Single-Sequence, Open-Label, 2-Period, Crossover Trial to Evaluate the Effect of the Proton Pump Inhibitor Esomeprazole 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 proton pump inhibitor (PPI) esomeprazole on the single-dose PK of orally administered TAK-906.

Detailed description

The drug being tested in this study is called TAK-906. TAK-906 is being tested in healthy participants to evaluate the effect of a PPI esomeprazole on the PK of TAK-906. The study will enroll approximately 12 participants. Participants will be assigned to the following treatment sequence: • TAK-906 25 mg; Esomeprazole 40 mg + TAK-906 25 mg All participants will be given an oral dose of TAK-906 and Esomeprazole. This single center trial will be conducted in the United States. The overall duration to participate in this study is 52 days. Participants will make visit to the clinic during Period 1 and Period 2 in addition to approximately 10 to 14 days after receiving their last dose of TAK-906 for a follow up assessment.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	TAK-906	TAK-906 capsules.
DRUG	Esomeprazole	Esomeprazole capsules.

Timeline

• Start date: 2019-02-27
• Primary completion: 2019-04-15
• Completion: 2019-04-15
• First posted: 2019-02-21
• Last updated: 2021-06-15
• Results posted: 2020-05-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study