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Completed

NCT Number: NCT02103569

Drug Interaction Study of an OCP (Norethindrone (ND) Acetate and Ethinyl Estradiol (EE))With a Combination of Daclatasvir (DCV) Asunaprevir (ASV) and BMS-791325

The purpose of this study is to assess the effect of DCV/ASV/BMS-791325 fixed dose combination (FDC) + 75mg BMS-791325 on the Pharmacokinetics (PK) of the oral contraceptive agent.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

About this study

IND Number: 79,599 and 101,943

Other: Phase 1 Clinical Pharmacology drug interaction study in healthy female subjects

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion criteria

  • Healthy females within age of 18-40 years
  • Must be a Women of Childbearing potential
  • Must be on a stable regimen of oral contraceptive therapy for at least 3 consecutive months prior to study start

Exclusion criteria

  • Subjects must not have any significant acute or chronic medical illnesses or conditions precluding safe use of oral contraceptives
  • Prior exposure to DCV, ASV or BMS-791325 within 30 days of dosing on study day 1
  • Smoking within 6 months of study start

Treatment and study plan

FDC of Daclatasvir, Asunaprevir and BMS-791325

Drug

FDC of Norethindrone and Ethinyl Estradiol

Drug

Other names: Loestrin®

BMS-791325

Drug

Primary outcomes

  1. Area under the concentration versus time curve in 1 dosing interval (AUC (TAU)) of Ethinyl Estradiol and Norethindrone

    Time frame: Day 21 to Day 49

  2. Maximum observed plasma concentration (Cmax) of Ethinyl Estradiol and Norethindrone

    Time frame: Day 21 to Day 49

Secondary outcomes

  1. Dose-normalized area under the concentration versus time curve in 1 dosing interval (AUC (TAU)) of Ethinyl Estradiol and Norethindrone

    Time frame: Day 1 to Day 50

  2. Dose-normalized maximum observed plasma concentration (Cmax) of Ethinyl Estradiol and Norethindrone

    Time frame: Day 1 to Day 50

  3. Time of maximum observed plasma concentration (Tmax) of Ethinyl Estradiol and Norethindrone

    Time frame: Day 1 to Day 50

  4. Safety measured by occurrence of Adverse events (AEs), serious AEs and AEs leading to discontinuation

    Time frame: Day 1 to Day 50

  5. Safety measured by abnormalities in vital sign measurements

    Time frame: Day 1 to Day 50

  6. Safety measured by findings on Electrocardiogram (ECG) measurements and physical examinations

    Time frame: Day 1 to Day 50

  7. Safety measured by marked abnormalities in clinical laboratory test results

    Time frame: Day 1 to Day 50

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Effect of a Combination of Daclatasvir, Asunaprevir, and BMS-791325 on the Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone Acetate in Healthy Female Subjects

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 4, 2014
Registry last updated
Aug 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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