Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-26 @ 8:41 PM
Study NCT ID:
NCT05818956
Status:
COMPLETED
Last Update Posted:
2024-08-06
First Post:
2023-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of TAK-227 in Healthy Adults
Sponsor:
Takeda
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: