Phase 1
Completed N=23
A Study of Evacetrapib in Healthy Female Participants
Healthy Volunteers
Source: ClinicalTrials.gov NCT01746732 ↗
Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcomePrimary: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ethinyl Estradiol — 71.7; 70.6 picogram per milliliter (pg/ml)
Summary
The purpose of this study is to evaluate the effects of evacetrapib on oral contraceptives (Ortho-Cyclen®) when given to healthy female participants. The amount of female hormones found in the blood will be measured and compared when taken alone and when taken with evaceptrapib. Each woman will participate in two study periods. Information about any side effects that may occur will also be collected.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ethinyl Estradiol |
71.7; 70.6 | — |
| PRIMARY PK: Area Under the Concentration Curve Over a 24 Hour Dosing Interval (AUCτ) of Ethinyl Estradiol |
907; 840 | — |
| PRIMARY PK: Minimum Observed Drug Concentration (Cmin) of Ethinyl Estradiol |
15.9; 13.2 | — |
| PRIMARY PK: Time of Maximum Observed Drug Concentration (Tmax) of Ethinyl Estradiol |
3.00; 4.00 | — |
| PRIMARY PK: Maximum Concentration (Cmax) of Norelgestromin |
1410; 1830 | — |
| PRIMARY PK: Area Under the Concentration Curve Over a 24 Hour Dosing Interval (AUCτ) of Norelgestromin |
16200; 18100 | — |
| PRIMARY PK: Minimum Observed Drug Concentration (Cmin) of Norelgestromin |
397; 422 | — |
| PRIMARY PK: Time of Maximum Observed Drug Concentration (Tmax) of Norelgestromin |
3.53; 4.00 | — |
Eligibility Criteria
Inclusion Criteria
- Are pre-menopausal females, and who are healthy as determined by medical history and physical examination
- Have a body mass index of 18 to 30 kilograms per square meter (kg/m^2)
Exclusion Criteria
- Have known allergies to evacetrapib and Ortho-Cyclen (ethinyl estradiol and norgestimate), related compounds or any components of the formulation
- Have a clinically significant abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
- Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
- Have taken injectable contraceptives within 12 months prior to the first dose of the lead-in period or topical controlled delivery contraceptives (patch) for 3 months prior to the first dose of the lead-in period
- Use of any tobacco- or nicotine-containing products within 6 months prior to the lead-in phase and during the study
Data sourced from ClinicalTrials.gov (NCT01746732). 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.