Ignite Creation Date:
2024-05-06 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04705922
Status:
COMPLETED
Last Update Posted:
2024-01-03
First Post:
2021-01-06
Brief Title:
Relative Bioavailability Study and Food Effect Study of TT-00420 Tinengotinib Capsule and Tablet Formulations in Healthy Volunteers
Sponsor:
TransThera Sciences Nanjing Inc
Organization:
TransThera Sciences Nanjing Inc
Study Overview
Official Title:
A Phase I Single-Center Open-Label 3-Way Crossover Randomized Single Dose Study to Evaluate the Food Effect on the Pharmacokinetics of TT-00420 Tablet and to Determine the Relative Bioavailability of TT-00420 Tablet Versus TT-00420 Capsule in Adult Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2023-12
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:
This study is an open-label 3-way crossover randomized study in adult healthy volunteers to evaluate the relative bioavailability of TT-00420 tablet and capsule formulations and to evaluate food effect on the pharmacokinetics of TT-00420 tablet
Detailed Description:
Subjects will be randomized to one of three treatment sequences Each sequence will contain up to 8 subjects In each treatment sequence subjects undergo a baselinescreening period three treatment periods and a follow-up visit
Subjects will be administered a single dose of TT-00420 on Day 1 of either TT-00420 tablet under fed condition TT-00420 tablet under fasting condition or capsule under fasting condition and crossed over after at least a 14-day washout period
Subjects will be administered a single dose of TT-00420 on Day 1 of either TT-00420 tablet under fed condition TT-00420 tablet under fasting condition or capsule under fasting condition and crossed over after at least a 14-day washout period
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