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NCT03856970 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Effect of IW-3718 on the Pharmacokinetics of Oral Contraceptive, Levothyroxine, Glyburide, and Digoxin in Healthy Adult Volunteers
A Phase 1 study, sponsored by Ironwood Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 87
- Enrollment target
NCT03856970: Completed Phase 1 study, sponsored by Ironwood Pharmaceuticals.
NCT03856970 is a Phase 1 study that has completed, run by Ironwood Pharmaceuticals. The registered enrollment target is 87 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03856970, a Phase 1 study, has completed, sponsored by Ironwood Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 87 participants
- Enrollment target
Study Summary
The primary objectives of this study are the following: * To evaluate the pharmacokinetics (PK) of a monophasic oral contraceptive's active components, ethinyl estradiol (EE) and norethindrone acetate (NET), following a single oral dose alone and in combination with IW-3718 in healthy adult female participants. * To evaluate the PK of levothyroxine following a single oral dose alone and in combination with IW-3718 in healthy adult participants. * To evaluate the PK of glyburide following a single oral dose alone and in combination with IW-3718 in healthy adult participants. * To evaluate the PK of digoxin following a single oral dose alone and in combination with IW-3718 in healthy adult participants.
Interventions
- DRUG Levothyroxine
- DRUG Digoxin
- DRUG IW-3718
- DRUG Glyburide
- DRUG Microgestin®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 87 participants |
| Start Date | 2019-03-11 |
| Est. Completion | 2019-07-03 |
| Phase | Phase 1 |
What the finished NCT03856970 record still lists
NCT03856970 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 87 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% higher).
The record links to 0 conditions, and to 5 interventions - of which Levothyroxine is the first listed.
NCT03856970 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03856970 about?
NCT03856970 is a clinical study titled "Study to Evaluate the Effect of IW-3718 on the Pharmacokinetics of Oral Contraceptive, Levothyroxine, Glyburide, and Digoxin in Healthy Adult Volunteers". The primary objectives of this study are the following: * To evaluate the pharmacokinetics (PK) of a monophasic oral contraceptive's active components, ethinyl estradiol (EE) and norethindrone acetate (NET), following a single oral dose alone and in combination with IW-3718 in healthy adult female ...
What is the current status of trial NCT03856970?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 87 participants. The study started on 2019-03-11. Estimated completion is 2019-07-03.
What interventions are being tested in trial NCT03856970?
The interventions under investigation include: Levothyroxine (DRUG), Digoxin (DRUG), IW-3718 (DRUG), Glyburide (DRUG), Microgestin® (DRUG).
Who is sponsoring clinical trial NCT03856970?
This trial is sponsored by Ironwood Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03856970's enrollment target sits among peer trials
87 651st of 2000 higher than 1,349 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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