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
Verified date | July 2017 |
Source | ViiV Healthcare |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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. |
Country | Name | City | State |
---|---|---|---|
United States | GSK Investigational Site | Miami | Florida |
United States | GSK Investigational Site | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
ViiV Healthcare | GlaxoSmithKline |
United States,
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 |
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