Healthy VolunteersPhase 1NCT01746732

A Study of Evacetrapib in Healthy Female Participants

A Phase 1 study testing Ortho-Cyclen and Evacetrapib in people with Healthy Volunteers, run by Eli Lilly and Company at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Ortho-Cyclen and Evacetrapib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23 participants
Where: 1 siteUnited States
Study dates: Dec 2012to May 2013
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

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, 75247

Other trials in United States

About this study

Official title: Effects of Evacetrapib (LY2484595) on the Pharmacokinetics of an Oral Contraceptive in Healthy Female Subjects

Conditions: Healthy Volunteers
Being tested: Ortho-Cyclen, Evacetrapib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ortho-CyclenDrug
Oral administration
EvacetrapibDrug
Also called LY2484595
Oral administration

Study groups in NCT01746732
Study group	Role	What they receive
Ortho-Cyclen	Experimental	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. Treatment A Receives: Drug: Ortho-Cyclen
Ortho-Cyclen + Evacetrapib	Experimental	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. Treatment B Receives: Drug: Ortho-Cyclen; Drug: Evacetrapib

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ethinyl Estradiol
Measured: Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose
PK: Area Under the Concentration Curve Over a 24 Hour Dosing Interval (AUCτ) of Ethinyl Estradiol
Measured: Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose
PK: Minimum Observed Drug Concentration (Cmin) of Ethinyl Estradiol
Measured: Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose
PK: Time of Maximum Observed Drug Concentration (Tmax) of Ethinyl Estradiol
Measured: Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose
PK: Maximum Concentration (Cmax) of Norelgestromin
Measured: Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose
PK: Area Under the Concentration Curve Over a 24 Hour Dosing Interval (AUCτ) of Norelgestromin
Measured: Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose
PK: Minimum Observed Drug Concentration (Cmin) of Norelgestromin
Measured: Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose
PK: Time of Maximum Observed Drug Concentration (Tmax) of Norelgestromin
Measured: Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2012May 2013

First posted11 Dec 2012 (estimated)
Study startDec 2012
Primary completionMay 2013
Study completionMay 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01746732
Sponsor's protocol ID: 14617
Other IDs: I1V-MC-EIAP
Status last verified: Feb 2018
First submitted: 7 Dec 2012
Last updated: 9 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Evacetrapib (LY2484595) on the Pharmacokinetics of an Oral Contraceptive in Healthy Female Subjects
ClinicalTrials.gov ID: NCT01746732
Acronym / sponsor ID: 14617
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Dec 2012
Primary completion: May 2013 (actual)
Study completion: May 2013 (actual)
First posted: 11 Dec 2012 (estimated)
Results: Posted 9 Oct 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Ortho-Cyclen	Experimental	Drug: Ortho-CyclenOrtho-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. Treatment A
Ortho-Cyclen + Evacetrapib	Experimental	Drug: Ortho-Cyclen, Drug: EvacetrapibOrtho-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. Treatment B

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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)

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ortho-CyclenOral administration	Drug	Ortho-Cyclen, Ortho-Cyclen + Evacetrapib
EvacetrapibAlso: LY2484595Oral administration	Drug	Ortho-Cyclen + Evacetrapib

Primary outcome

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ethinyl Estradiol
Time frame: Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose
PK: Area Under the Concentration Curve Over a 24 Hour Dosing Interval (AUCτ) of Ethinyl Estradiol
Time frame: Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose
PK: Minimum Observed Drug Concentration (Cmin) of Ethinyl Estradiol
Time frame: Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose
PK: Time of Maximum Observed Drug Concentration (Tmax) of Ethinyl Estradiol
Time frame: Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose
PK: Maximum Concentration (Cmax) of Norelgestromin
Time frame: Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose
PK: Area Under the Concentration Curve Over a 24 Hour Dosing Interval (AUCτ) of Norelgestromin
Time frame: Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose
PK: Minimum Observed Drug Concentration (Cmin) of Norelgestromin
Time frame: Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose
PK: Time of Maximum Observed Drug Concentration (Tmax) of Norelgestromin
Time frame: Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose

Results and safety

Results posted to the registry on 9 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ortho-Cyclen	23	22
Ortho-Cyclen Then Ortho-Cyclen + Evacetrapib; Sequence AB	0	0
Ortho-Cyclen + Evacetrapib Then Ortho-Cyclen; Sequence BA	0	0

Primary outcome: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ethinyl Estradiol

Time frame: Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose. Geometric mean (Geometric Coefficient of Variation). Unit: picogram per milliliter (pg/ml)

Measure	Ortho-Cyclen n = 16	Ortho-Cyclen + Evacetrapib n = 17
Value	71.7 (35)	70.6 (37)

Population analysed: All participants who received at least one dose of study drug and had evaluable PK data.

Primary outcome: PK: Area Under the Concentration Curve Over a 24 Hour Dosing Interval (AUCτ) of Ethinyl Estradiol

Time frame: Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose. Geometric mean (Geometric Coefficient of Variation). Unit: picogram x hour per ml (pg*hour/ml)

Measure	Ortho-Cyclen n = 16	Ortho-Cyclen + Evacetrapib n = 17
Value	907 (31)	840 (28)

Population analysed: All participants who received at least one dose of study drug and had evaluable PK data.

Primary outcome: PK: Minimum Observed Drug Concentration (Cmin) of Ethinyl Estradiol

Time frame: Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose. Geometric mean (Geometric Coefficient of Variation). Unit: pg/ml

Measure	Ortho-Cyclen n = 16	Ortho-Cyclen + Evacetrapib n = 17
Value	15.9 (65)	13.2 (66)

Population analysed: All participants who received at least one dose of study drug and had evaluable PK data.

Primary outcome: PK: Time of Maximum Observed Drug Concentration (Tmax) of Ethinyl Estradiol

Time frame: Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose. Median (Full Range). Unit: hour

Measure	Ortho-Cyclen n = 16	Ortho-Cyclen + Evacetrapib n = 17
Value	3.00 (0.50 to 12.00)	4.00 (1.02 to 5.00)

Population analysed: All participants who received at least one dose of study drug and had evaluable PK data.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ortho-Cyclen (Lead-in Phase)	0 of 22 (0%)	9 of 22 (40.9%)	Not reported
Ortho-Cyclen	0 of 17 (0%)	5 of 17 (29.4%)	Not reported
Ortho-Cyclen + Evacetrapib	0 of 21 (0%)	5 of 21 (23.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ortho-Cyclen and Evacetrapib in people with Healthy Volunteers, run by Eli Lilly and Company at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ethinyl Estradiol (time frame: Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01746732.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2018.