Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2026-01-11 @ 3:35 PM
Study NCT ID:
NCT03103412
Status:
COMPLETED
Last Update Posted:
2021-01-14
First Post:
2017-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TD-3504 SAD in Healthy Subjects and Subjects With Ulcerative Colitis (UC)
Sponsor:
Theravance Biopharma
Organization:
Study Overview
Official Title:
Study 0146: A Phase 1a, Double-Blinded, Randomized, Placebo Controlled, Single Ascending Dose (SAD) Study to Evaluate the Safety, Tolerability, and Systemic Exposure of TD-3504 in Healthy Subjects and Subjects With Ulcerative Colitis (UC)
Status:
COMPLETED
Status Verified Date:
2021-01
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 designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of single-dose TD-3504 and single dose 15N2-tofacitinib in healthy subjects and subjects with UC. The relative bioavailability of tofacitinib released from TD-3504 compared to co-administered oral heavy-labeled tofacitinib (15N2-tofacitinib) will also be evaluated.
Detailed Description:
None
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?: