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

NCT04309643 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2020-07-16

No results posted yet for this 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.

Conditions

  • Healthy Volunteers

Interventions

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)

Sponsors & Collaborators

  • Celerion

    collaborator INDUSTRY

  • Concert Pharmaceuticals

    lead INDUSTRY

Study Design

Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-09
Primary Completion
2020-06-25
Completion
2020-07-08
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04309643 on ClinicalTrials.gov