NCT04831502

Bioavailability and Food Effect Study of Two Formulations of TAK-906

A Phase 1, Open Label, Randomized, Single-Dose, Replicate Crossover Study to Determine the Bioavailability of the Tablet Formulation Relative to the Capsule Formulation of TAK-906 and the Effect of Food on the Pharmacokinetics of the Tablet Formulation in Healthy Subjects

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to understand how TAK-906 tablets and capsules are processed by the body in healthy adults under fasting conditions and also how TAK-906 tablets are processed by the body when taken with a high fat high calorie breakfast compared to fasting. This study will require participants to stay at the clinical research unit for about 3 weeks to be monitored after receiving TAK-906.

Detailed description

The drug being tested in this study is called TAK-906. This study will compare the pharmacokinetics (PK) of single oral dose of 50 mg tablet (test \[Treatment B\]) relative to single oral dose of 50 mg capsule (reference \[Treatment A\]) under fasted conditions. The study will also explore the effect of food on 50 mg tablet formulation (Treatment C: high-fat/high-calorie meal) on TAK-906 PK following tablet administration relative to the fasted state (Treatment B). The study will enroll approximately 24 participants. Participants will be randomly assigned to 1 of the 2 treatment sequences. This single-center trial will be conducted in the United States. The overall time to participate in this study is approximately 60 days. Participants will be followed up for up to 14 days after the last dose of study drug for a follow-up assessment.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	TAK-906	TAK-906 Tablets.
DRUG	TAK-906	TAK-906 Capsules.

Timeline

• Start date: 2021-04-02
• Primary completion: 2022-02-02
• Completion: 2022-02-02
• First posted: 2021-04-05
• Last updated: 2022-03-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study