NCT05818956

A Study of TAK-227 in Healthy Adults

A Randomized, Open-label, Single-dose, Three-way Crossover Evaluation of the Effect of Food on the Pharmacokinetics, Safety, and Tolerability of TAK-227 in Healthy Adult Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The main aim of this study is to test the effects of food consumption with sponsor compound TAK-227 in healthy participants. The study will also measure side effects, and to check how much TAK-227 stays in the blood over time to work out the best dose.

Detailed description

The drug being tested in this study is called TAK-227. This study will assess the effect of food on single-dose of TAK-227 in healthy participants. The study will enroll approximately 24 participants. A single dose of 50 milligram (mg) TAK-227 will be administered orally under one of 3 different feeding conditions. * Fasting (Treatment A), * Fed following a high-fat or high-calorie meal prior to dosing (Treatment B), and * Fed following a high-fat or high-calorie meal after dosing (Treatment C) Participants will be randomly assigned to 1 of the 6 treatments sequences based on the 3 feeding conditions. * Sequence 1: (Treatment A + Treatment B + Treatment C) * Sequence 2: (Treatment B + Treatment C + Treatment A) * Sequence 3: (Treatment C + Treatment A + Treatment B) * Sequence 4: (Treatment A + Treatment C + Treatment B) * Sequence 5: (Treatment B + Treatment A + Treatment C) * Sequence 6: (Treatment C + Treatment B + Treatment A) All participants will receive all 6 treatment regimens. This is a single-center trial. Participants will be followed up for up to 7 days after the last dose of study drug for a follow-up assessment. The overall time to participate in this study is approximately 40 days including screening period and follow-up period.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	TAK-227	TAK-227 capsules.

Timeline

• Start date: 2023-05-25
• Primary completion: 2023-06-19
• Completion: 2023-06-26
• First posted: 2023-04-19
• Last updated: 2024-08-06
• Results posted: 2024-08-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study