Trials / Completed
CompletedNCT04309643
Drug-drug Interaction Study of CTP-543 and Oral Contraceptives in Healthy Female Subjects
A Phase 1, Open-label Study to Assess the Effect of CTP-543 on the Pharmacokinetics of Oral Contraceptives in Healthy Adult Female Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- Concert Pharmaceuticals · Industry
- Sex
- Female
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
This is a Phase 1, fixed sequence, multiple dose, open-label study of the effect of CTP-543 on oral contraceptive pharmacokinetics in healthy female subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CTP-543 | Investigational Drug |
| DRUG | Combined oral contraceptive containing Ethinyl estradiol (EE) and Levonorgestrel (LNG) | Oral contraceptive in the form of 1 fixed combination tablet of Seasonique or generic equivalent (0.03 mg EE / 0.15 mg LNG) |
Timeline
- Start date
- 2020-06-09
- Primary completion
- 2020-06-25
- Completion
- 2020-07-08
- First posted
- 2020-03-16
- Last updated
- 2020-07-16
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04309643. Inclusion in this directory is not an endorsement.