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

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ClinicalTrials.gov Identifier: NCT02103569
Recruitment Status : Completed
First Posted : April 4, 2014
Last Update Posted : August 15, 2014
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: FDC of Daclatasvir, Asunaprevir and BMS-791325 Drug: FDC of Norethindrone and Ethinyl Estradiol Drug: BMS-791325 Phase 1

Detailed Description:

IND Number: 79,599 and 101,943

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official 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
Study Start Date : April 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1: FDC of NE/EE + DCV 3DAA FDC + BMS-791325

Cycle 1- Low dose FDC of Norethindrone and Ethinyl Estradiol tablet orally on specified days

Cycle 2- High dose FDC of Norethindrone and Ethinyl Estradiol tablet orally on specified days and High dose FDC of Norethindrone and Ethinyl Estradiol + FDC of Daclatasvir, Asunaprevir and BMS-791325 + BMS-791325 tablets orally on specified days

 Drug: FDC of Daclatasvir, Asunaprevir and BMS-791325
Drug: FDC of Norethindrone and Ethinyl Estradiol
Other Name: Loestrin®

Drug: BMS-791325


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02103569


Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol Myers Squibb Bristol-Myers Squibb
More Information
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02103569    
Other Study ID Numbers: AI443-016
First Posted: April 4, 2014    Key Record Dates
Last Update Posted: August 15, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Blood-Borne Infections
Communicable Diseases
Infections
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Ethinyl Estradiol
Norethindrone
Norethindrone Acetate
Estradiol
 Asunaprevir
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents, Hormonal
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Hormonal
Contraceptives, Oral
Contraceptives, Oral, Synthetic
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action