A Drug-drug Interaction Study Between BMS-663068 and Oral Contraceptives in Healthy Female Volunteers (DDI)

Infection, Human Immunodeficiency Virus Clinical Trial

Official title:

Effect of BMS-663068 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: NCT02480881
• Other study ID #: 206279
• Secondary ID: AI438-019
• Status: Completed
• Phase: Phase 1
• First received: June 18, 2015
• Last updated: July 25, 2017
• Start date: July 7, 2015
• Est. completion date: January 11, 2016

Study information

• Verified date: July 2017
• Source: ViiV Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open-label, single sequence, 4-cycle, 4-treatment, drug-drug interaction (DDI) study in healthy female subjects on oral contraceptives (OC). There is no formal research hypothesis to be statistically tested. It is expected that coadministration of BMS-663068 with OC will not affect the pharmacokinetics (PK) of either ethinyl estradiol (EE) or norethindrone (NE).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: January 11, 2016
• Est. primary completion date: January 11, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Healthy female nonsmoking subjects, ages 18 to 40 years, inclusive with a body mass index of 18.0 kg/m2 to 32.0 kg/m2, inclusive

• Women of child bearing potential with intact ovarian function by medical history and history of regular menstrual cycles must have been on a stable regimen of combination oral contraceptives containing EE and progestin (28 day regimen) without evidence of breakthrough bleeding or spotting for at least 2 consecutive months prior to Day -1

Exclusion Criteria:

• Any significant acute or chronic medical illness

Other protocol defined exclusion criteria could apply.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Immunologic Deficiency Syndromes
• Infection, Human Immunodeficiency Virus

Intervention

Drug:
• BMS-663068
Investigational product
• Oral Contraceptive
Subject's existing combination OC tablet containing EE and progestin
• Loestrin 1.5/30
OC containing EE and norethindrone acetate (NEA)

Locations

Country	Name	City	State
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
ViiV Healthcare	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic parameter Cmax	Pharmacokinetic parameter includes: maximal observed concentration (Cmax) for EE and NE.	From Day 21 of Treatment C/Cycle 3 to Day 21 of Treatment D/Cycle 4
Primary	Pharmacokinetic parameter AUC TAU	Pharmacokinetic parameter includes: area under the concentration-time curve in one dosing interval (AUC(TAU)) for EE and NE.	From Day 21 of Treatment C/Cycle 3 to Day 21 of Treatment D/Cycle 4
Secondary	Clinical Safety as Measured by Adverse Event Monitoring.	Adverse event monitoring	From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4)
Secondary	Clinical Safety as Measured by the Collection of Vital Signs.	Vital signs assessments	From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4)
Secondary	Clinical Safety as Measured by the Collection of Electrocardiograms (ECGs).	12-lead ECGs	From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4)
Secondary	Clinical Safety as measured by Physical Examination.	Physical examinations	From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4)
Secondary	Clinical Safety as Measured by Clinical Laboratory Evaluations.	clinical chemistry, hematology, and urinalysis.	From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4)
Secondary	Pharmacokinetic Parameter	Pharmacokinetic parameter: -time of maximum observed concentration (Tmax) for EE and NE.	From Day 21 of Treatment C/Cycle 3 to Day 21 of Treatment D/Cycle 4