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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 is a Phase 1 study that has completed, run by Ironwood Pharmaceuticals. The registered enrollment target is 87 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03856970
The ClinicalTrials.gov registry entry for NCT03856970 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 87 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ironwood Pharmaceuticals, which has 23 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Levothyroxine is the first listed.
NCT03856970 reports 0 study locations.
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.
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