A Study of Evacetrapib in Healthy Female Participants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01746732
First received: December 7, 2012
Last updated: June 18, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Healthy Volunteers
Drug: Ortho-Cyclen
Drug: Evacetrapib
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Effects of Evacetrapib (LY2484595) on the Pharmacokinetics of an Oral Contraceptive in Healthy Female Subjects

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Pharmacokinetics (PK): Maximum Concentration (Cmax) of Norgestimate/Ethinyl Estradiol [ Time Frame: Predose up to 24 hours Post-dose on Day 21 ] [ Designated as safety issue: No ]
  • Pharmacokinetics (PK): Area Under the Concentration Curve Over a 24 Hour Dosing Interval (AUCτ) of Norgestimate/Ethinyl Estradiol [ Time Frame: Predose up to 24 hours Post-dose on Day 21 ] [ Designated as safety issue: No ]
  • Pharmacokinetics (PK): Minimum Observed Drug Concentration (Cmin) of Norgestimate/Ethinyl Estradiol [ Time Frame: Predose up to 24 hours Post-dose on Day 21 ] [ Designated as safety issue: No ]
  • Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of Norgestimate/Ethinyl Estradiol [ Time Frame: Predose up to 24 hours Post-dose on Day 21 ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: December 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ortho-Cyclen
Ortho-Cyclen (35 microgram (mcg) ethinyl estradiol and 250 mcg norgestimate) administered orally, once daily (QD), for 28 days (lead-in period). Then, Ortho-Cyclen orally QD for 28 Days (Days 1 to 28) in one of two treatment periods.
Drug: Ortho-Cyclen
Oral administration
Experimental: Ortho-Cyclen + Evacetrapib
Ortho-Cyclen administered orally, QD, for 28 days (lead-in period). Then, Ortho-Cyclen orally QD for 28 Days (Days 1 to 28) and 130 mg evacetrapib orally, QD, for 21 days (Days 1 to 21) in one of two treatment periods.
Drug: Ortho-Cyclen
Oral administration
Drug: Evacetrapib
Oral administration
Other Name: LY2484595

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01746732

Locations
United States, Texas
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Dallas, Texas, United States, 75247
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01746732     History of Changes
Other Study ID Numbers: 14617, I1V-MC-EIAP
Study First Received: December 7, 2012
Last Updated: June 18, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Evacetrapib
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014