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NCT04309643 · ClinicalTrials.gov registry record · Phase 1

Drug-drug Interaction Study of CTP-543 and Oral Contraceptives in Healthy Female Subjects

A Phase 1 study, sponsored by Concert Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
21
Enrollment target

NCT04309643: Completed Phase 1 study, sponsored by Concert Pharmaceuticals.

NCT04309643 is a Phase 1 study that has completed, run by Concert Pharmaceuticals. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04309643, a Phase 1 study, has completed, sponsored by Concert Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
21 participants
Enrollment target

Study 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.

Primary Outcome

Area Under the Plasma Concentration-Time Profile

Interventions

  • DRUG CTP-543
  • DRUG Combined oral contraceptive containing Ethinyl estradiol (EE) and Levonorgestrel (LNG)

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2020-06-09
Est. Completion 2020-07-08
Phase Phase 1
Concert Pharmaceuticals

24 total trials

What the finished NCT04309643 record still lists

NCT04309643 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).

The record links to 0 conditions, and to 2 interventions - of which CTP-543 is the first listed.

NCT04309643 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04309643 about?

NCT04309643 is a clinical study titled "Drug-drug Interaction Study of CTP-543 and Oral Contraceptives in Healthy Female Subjects". 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.

What is the current status of trial NCT04309643?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2020-06-09. Estimated completion is 2020-07-08.

What interventions are being tested in trial NCT04309643?

The interventions under investigation include: CTP-543 (DRUG), Combined oral contraceptive containing Ethinyl estradiol (EE) and Levonorgestrel (LNG) (DRUG).

Who is sponsoring clinical trial NCT04309643?

This trial is sponsored by Concert Pharmaceuticals, which has 24 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04309643's enrollment target sits among peer trials

21 1615th of 2000 higher than 372 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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Source: ClinicalTrials.gov NCT04309643, the US trial registry maintained by the National Library of Medicine. NCT04309643 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.