NCT03708211

A Study to Assess the Relative Bioavailability, Effect of Food, and Gastric Potential Hydrogen (pH) Modification on the Pharmacokinetics (PK) of TAK-931 in Participants With Advanced Solid Tumors

A Phase 1, Open-Label Study to Assess the Relative Bioavailability, Effect of Food, and Gastric pH Modification on the Pharmacokinetics of TAK-931 in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to estimate the relative bioavailability of TAK-931 tablets in reference to powder-in capsule (PIC) and to assess the effect of food and esomeprazole on the pharmacokinetics (PK) of TAK-931 as a tablet.

Detailed description

The drug being tested in this study is called TAK-931. TAK 931 is being tested to treat participants who have advanced solid tumors. This study will look at relative bioavailability, effect of food and gastric pH modification on the PK of TAK-931. The study will enroll approximately 44 participants. The study will be conducted in 2 parts: Part 1 and Part 2. In Part 1 and Part 2, participants will be randomly assigned (by chance, like flipping a coin) in a crossover design. In Part 1, participants will be assigned to 1 of the 2 following treatment sequences: * TAK-931 80 mg PIC + TAK-931 80 mg Tablet * TAK-931 80 mg Tablet + TAK-931 80 mg PIC Part 2 of the study will be initiated, once the preliminary PK data from Part 1 is available to determine the relative bioavailability of the tablet formulation in reference to PIC and to calculate the single dose of TAK-931 tablet to be used in Part 2.In Part 2, participants will be assigned to 1 of the 2 following treatment sequences: * TAK-931 TBD Fed + TAK-931 TBD Fasted * TAK-931 TBD Fasted + TAK-931 TBD Fed This multi-center trial will be conducted in the Netherlands. The overall time to participate in this study is approximately 2 years. Participants will make multiple visits to the clinic and will be contacted for approximately 30 days after receiving their last dose of study drug or until the start of subsequent anticancer therapy, whichever occurs first for a follow up assessment.

Conditions

• Neoplasms, Advanced Solid

Interventions

Type	Name	Description
DRUG	TAK-931 PIC	TAK-931 PICs.
DRUG	TAK-931 Tablet	TAK-931 Tablets.
DRUG	Esomeprazole	Esomeprazole Tablets.

Timeline

• Start date: 2019-03-28
• Primary completion: 2019-12-03
• Completion: 2019-12-03
• First posted: 2018-10-17
• Last updated: 2020-12-29
• Results posted: 2020-12-29

Locations

4 sites across 1 country: Netherlands

Regulatory

• FDA-regulated drug study