Ignite Creation Date:
2024-05-06 @ 3:17 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04587713
Status:
COMPLETED
Last Update Posted:
2021-04-09
First Post:
2020-10-07
Brief Title:
Single Dose Bioavailability and Ethnobridging PK Study in Healthy Subjects
Sponsor:
Theravance Biopharma
Organization:
Theravance Biopharma
Study Overview
Official Title:
A Phase 1 Two-Part Open-Label Study to Assess the Relative Bioavailability of Two TD-1473 Tablet Formulations Under Fasted and Fed Conditions in Healthy Subjects and the Pharmacokinetics of TD-1473 in Healthy Chinese Subjects
Status:
COMPLETED
Status Verified Date:
2021-04
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 is a Phase 1 2-part open-label study Part A will be a formulation bridging and food effect study in healthy adult subjects Part B will be an assessment of pharmacokinetics PK in healthy adult Chinese subjects
Detailed Description:
In study Part A healthy adult subjects will receive the following treatments in a cross-over design with a 10-day washout period between doses
Treatment A Single dose of Tablet A TD-1473 proposed commercial tablet formulation on Day 1 in a fasted state
Treatment B Single dose of Tablet A TD-1473 proposed commercial tablet formulation on Day 1 in a fed state
Treatment C Single dose of Tablet B TD-1473 current clinical tablet formulation on Day 1 in a fasted state
Treatment D Single dose of Tablet B TD-1473 current clinical tablet formulation on Day 1 in a fed state
In study Part B healthy adult Chinese subjects will receive Treatment A Single dose of Tablet A TD-1473 proposed commercial tablet formulation on Day 1 in a fasted state
Treatment A Single dose of Tablet A TD-1473 proposed commercial tablet formulation on Day 1 in a fasted state
Treatment B Single dose of Tablet A TD-1473 proposed commercial tablet formulation on Day 1 in a fed state
Treatment C Single dose of Tablet B TD-1473 current clinical tablet formulation on Day 1 in a fasted state
Treatment D Single dose of Tablet B TD-1473 current clinical tablet formulation on Day 1 in a fed state
In study Part B healthy adult Chinese subjects will receive Treatment A Single dose of Tablet A TD-1473 proposed commercial tablet formulation on Day 1 in a fasted state
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