Phase 1
Completed N=20
Study to Assess the Effect of BMS-790052 on the Pharmacokinetics of Ortho Tri-Cyclen® in Healthy Female Subjects
Chronic Hepatitis C
Source: ClinicalTrials.gov NCT00983957 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Sep 2015
Primary outcomePrimary: Maximum Observed Plasma Concentration (Cmax) of Ethinyl Estradiol — 118.53; 134.70 picogram per millilitre (pg/mL)
Summary
The purpose of this study is to assess the effect of BMS-790052 on the pharmacokinetics of Ortho Tri-Cyclen® in healthy female subjects.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of Ethinyl Estradiol |
118.53; 134.70 | — |
| PRIMARY Area Under the Concentration-Time Curve (AUC) in 1 Dosing Interval of Ethinyl Estradiol |
959.37; 994.40 | — |
| PRIMARY Time of Maximum Observed Plasma Concentration of Ethinyl Estradiol |
1.5; 1.5 | — |
| PRIMARY Maximum Observed Plasma Concentration of Norelgestromin |
1.99; 2.10 | — |
| PRIMARY Area Under the Concentration-Time Curve in 1 Dosing Interval of Norelgestromin |
15.38; 16.84 | — |
| PRIMARY Time of Maximum Observed Plasma Concentration of Norelgestromin |
1.3; 1.5 | — |
| SECONDARY Maximum Observed Plasma Concentration of Norgestrel |
2674.69; 2815.98 | — |
| SECONDARY Area Under the Concentration-Time Curve in 1 Dosing Interval of Norgestrel |
47258.35; 51760.43 | — |
| SECONDARY Time of Maximum Observed Plasma Concentration of Norgestrel |
1.8; 2.0 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Who Died |
0; 0; 0; 1; 0; 0 | — |
| SECONDARY Number of Participants With Laboratory Test Abnormalities |
1; 0; 1; 0; 1; 0 | — |
| SECONDARY Number of Participants Demonstrating a Clinically Meaningful Effect in Vital Signs |
0; 0 | — |
| SECONDARY Number of Participants Demonstrating a Clinically Meaningful Effect in ECG Parameters |
0; 0 | — |
Eligibility Criteria
Key Inclusion Criteria
- Healthy female subjects, 18-45 years, BMI 18-32 kg/m².
- Must be using an adequate method of contraception to avoid pregnancy throughout the study.
Key Exclusion Criteria
- Abnormal Pap smear within 1 yr of dosing, and abnormal menstrual cycle during the 3 months prior to enrollment.
- Any significant or chronic uncontrolled medical illness.
Data sourced from ClinicalTrials.gov (NCT00983957). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.