Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
Study NCT ID:
NCT04831502
Status:
WITHDRAWN
Last Update Posted:
2022-03-24
First Post:
2021-04-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bioavailability and Food Effect Study of Two Formulations of TAK-906
Sponsor:
Takeda
Organization:
Study Overview
Official Title:
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WITHDRAWN
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Business decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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.
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?:
None
Is an FDA AA801 Violation?: