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NCT03103412 · ClinicalTrials.gov registry record · Phase 1
TD-3504 SAD in Healthy Subjects and Subjects With Ulcerative Colitis (UC)
A Phase 1 study, sponsored by Theravance Biopharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT03103412 is a Phase 1 study that has completed, run by Theravance Biopharma. The registered enrollment target is 32 participants.
The verdict
NCT03103412, a Phase 1 study, has completed, sponsored by Theravance Biopharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG TD-3504
- DRUG 15N2-tofacitinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2017-05-04 |
| Est. Completion | 2017-11-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03103412
The ClinicalTrials.gov registry entry for NCT03103412 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Theravance Biopharma, which has 38 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03103412 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03103412 about?
NCT03103412 is a clinical study titled "TD-3504 SAD in Healthy Subjects and Subjects With Ulcerative Colitis (UC)". 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 to...
What is the current status of trial NCT03103412?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2017-05-04. Estimated completion is 2017-11-08.
What interventions are being tested in trial NCT03103412?
The interventions under investigation include: Placebo (DRUG), TD-3504 (DRUG), 15N2-tofacitinib (DRUG).
Who is sponsoring clinical trial NCT03103412?
This trial is sponsored by Theravance Biopharma, which has 38 total clinical trials registered on ClinicalTrials.gov.
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