Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04831502
Status:
WITHDRAWN
Last Update Posted:
2022-03-24
First Post:
2021-04-01
Brief Title:
Bioavailability and Food Effect Study of Two Formulations of TAK-906
Sponsor:
Takeda
Organization:
Takeda
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WITHDRAWN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-fathigh-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:
None
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?:
None