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NCT04309643
Drug-drug Interaction Study of CTP-543 and Oral Contraceptives in Healthy Female Subjects
Phase 1 trial testing CTP-543 in Healthy Volunteers in 21 participants. Completed in 8 July 2020.
25 June 2020
Quick facts
| Lead sponsor | Concert Pharmaceuticals |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Design | sequential |
| Masking | none |
| Primary purpose | other |
| Enrollment | 21 |
| Start date | 9 June 2020 |
| Primary completion | 25 June 2020 |
| Estimated completion | 8 July 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- CTP-543 — full drug profile →
- Combined oral contraceptive containing Ethinyl estradiol (EE) and Levonorgestrel (LNG) — full drug profile →
Conditions studied
- Healthy Volunteers — all drugs for Healthy Volunteers →
Sponsor
Concert Pharmaceuticals — full company profile →
Who can join
Adults 18 to 65, female only, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04309643
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of CTP-543
Trials testing the same drug.
- NCT05478772 — Study to Evaluate Multiple Doses of Fluconazole, a CYP3A4 and CYP2C9 Inhibitor, on the Pharmacokinetics of CTP-543 in He · Phase 1 · completed
- NCT05467709 — Study To Evaluate The Effect Of Multiple Doses of CTP-543 On The Pharmacokinetics Of Single Doses of Midazolam In Health · Phase 1 · completed
- NCT05467696 — Study of the Effect of Food on the Bioavailability of the To-Be-Marketed Formulation of CTP-543 in Healthy Volunteers · Phase 1 · completed
- NCT05468749 — Study to Assess the Effect of Renal Impairment on the Pharmacokinetics of CTP-543 · Phase 1 · completed
- NCT05467722 — Study to Assess the Effect of Hepatic Impairment on the Pharmacokinetics of CTP-543 · Phase 1 · completed
Other recruiting trials for Healthy Volunteers
Currently open trials in the same condition.
- NCT07504003 — Influence of Training Session Duration on Improvements in Physiological Resilience to Exercise · NA · recruiting
- NCT07446400 — A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuva · Phase 1 · recruiting
- NCT07495813 — A Study to See How RO7763505 Works and How Safe it is When Given to Healthy People and People With Stable Heart Disease · Phase 1 · recruiting
- NCT07499050 — A Study of Multiple Doses of Orally Administered RO7795081 in Otherwise Healthy Chinese Adult Participants With Obesity · Phase 1 · recruiting
- NCT07342114 — A Dose-Escalation Study of RO7875913 in Healthy Participants · Phase 1 · recruiting
Other Concert Pharmaceuticals trials
Trials by the same sponsor.
- NCT05478772 — Study to Evaluate Multiple Doses of Fluconazole, a CYP3A4 and CYP2C9 Inhibitor, on the Pharmacokinetics of CTP-543 in He · Phase 1 · completed
- NCT05467709 — Study To Evaluate The Effect Of Multiple Doses of CTP-543 On The Pharmacokinetics Of Single Doses of Midazolam In Health · Phase 1 · completed
- NCT05467696 — Study of the Effect of Food on the Bioavailability of the To-Be-Marketed Formulation of CTP-543 in Healthy Volunteers · Phase 1 · completed
- NCT05468749 — Study to Assess the Effect of Renal Impairment on the Pharmacokinetics of CTP-543 · Phase 1 · completed
- NCT05467722 — Study to Assess the Effect of Hepatic Impairment on the Pharmacokinetics of CTP-543 · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04309643 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Concert Pharmaceuticals
- Last refreshed: 16 July 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04309643.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing