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

Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02103569
• Other study ID #: AI443-016
• Status: Completed
• Phase: Phase 1
• First received: April 1, 2014
• Last updated: August 13, 2014
• Start date: April 2014
• Est. completion date: July 2014

Study information

• Verified date: August 2014
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

IND Number: 79,599 and 101,943

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hepatitis C

Intervention

Drug:
• FDC of Daclatasvir, Asunaprevir and BMS-791325

• FDC of Norethindrone and Ethinyl Estradiol

• BMS-791325

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the concentration versus time curve in 1 dosing interval (AUC (TAU)) of Ethinyl Estradiol and Norethindrone		Day 21 to Day 49	No
Primary	Maximum observed plasma concentration (Cmax) of Ethinyl Estradiol and Norethindrone		Day 21 to Day 49	No
Secondary	Dose-normalized area under the concentration versus time curve in 1 dosing interval (AUC (TAU)) of Ethinyl Estradiol and Norethindrone		Day 1 to Day 50	No
Secondary	Dose-normalized maximum observed plasma concentration (Cmax) of Ethinyl Estradiol and Norethindrone		Day 1 to Day 50	No
Secondary	Time of maximum observed plasma concentration (Tmax) of Ethinyl Estradiol and Norethindrone		Day 1 to Day 50	No
Secondary	Safety measured by occurrence of Adverse events (AEs), serious AEs and AEs leading to discontinuation		Day 1 to Day 50	Yes
Secondary	Safety measured by abnormalities in vital sign measurements		Day 1 to Day 50	Yes
Secondary	Safety measured by findings on Electrocardiogram (ECG) measurements and physical examinations		Day 1 to Day 50	Yes
Secondary	Safety measured by marked abnormalities in clinical laboratory test results		Day 1 to Day 50	Yes