Depressive Disorder, MajorPhase 1NCT01373931

A Study of LY2216684 in Healthy Females

A Phase 1 study testing LY2216684 and Ortho Cyclen in people with Depressive Disorder, Major, 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

This study involves a single dose of 18 milligrams (mg) LY2216684 taken as 1 or 2 tablets by mouth. The study will evaluate effect of LY2216684 on the pharmacokinetics of an oral contraceptive Ortho Cyclen®. This study will run approximately 93 days. 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: Depressive Disorder, Major
What is being tested?: LY2216684 and Ortho Cyclen
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 20 participants
Where: 1 siteUnited States
Study dates: Jun 2011to Dec 2011
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 overtly healthy females, as determined by medical history and physical examination
As it is possible that LY2216684 may cause the oral contraceptive tablet to be less effective than usual, participants will be required in addition to use double barrier methods of contraception from the Screening until 2 months after the post study follow-up. Additional barrier methods of contraception may include the following: a non-hormonal intrauterine device with spermicide; female condom with spermicide; contraceptive sponge with spermicide; diaphragm with spermicide; cervical cap with spermicide; a male sexual partner who agrees to use a male condom with spermicide; a sterile sexual partner; or abstinence (participants reporting abstinence who become sexually active while on the study must agree to use other additional barrier methods of contraception). The pregnancy test result must be negative at Screening and at each Check-in
Have a body weight of >50 kilograms (kg)
Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
Have venous access sufficient to allow for blood sampling as per the protocol
Have normal blood pressure and pulse rate (sitting position) as determined by the investigator
Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
Have given written informed consent approved by Lilly and the institutional review board (IRB) governing the site

Who cannot join

Are currently enrolled in, have completed or discontinued within the last 30 days from, a clinical trial involving an investigational product other than the investigational product used in this study, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Have known allergies to Ortho Cyclen, LY2216684, or related compounds
Are participants who have previously completed or withdrawn from this study or any other study investigating LY2216684 within 6 months prior to Screening
Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
Have a history or show evidence of significant active neuropsychiatric disease or have a history or suicide attempt or ideation

Show all 21Show fewer

Regular use of known drugs of abuse and/or show positive findings on urinary drug screening
Show evidence of human immunodeficiency virus infection (HIV) and/or positive human HIV antibodies
Show evidence of hepatitis C and/or positive hepatitis C antibody
Show evidence of hepatitis B and/or positive hepatitis B surface antigen
Are women with a positive pregnancy test or women who are lactating
Intend to use over-the-counter or prescription medication (other than the acceptable oral contraceptive allowed in this study and influenza vaccinations) within 14 days prior to dosing unless deemed acceptable by the investigator and sponsor's medical monitor
Have donated blood of more than 500 milliliter (mL) prior to lead-in phase Check-in (Day -1)
Have an average weekly alcohol intake that exceeds 14 units per week, or are unwilling to stop alcohol consumption for 48 hours prior to each Check-in to the clinical research unit (CRU) [1 unit = 12 ounces (oz) or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits]
Consume 5 or more cups of coffee (or other beverages of comparable caffeine content) per day, on a habitual basis, or any participants unwilling to adhere to study caffeine restrictions
Use of any tobacco- or nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months prior to the lead-in phase Check-in (Day -1) and during the study
Have consumed grapefruit, starfruit, pomegranates, or products containing those items 7 days prior to enrollment or are unwilling to avoid them during the study
Have a documented or suspected history of glaucoma
Participants that have taken injectable contraceptives within 12 months of enrollment to this study or topical controlled delivery contraceptives (patch) for 3 months prior to enrollment into this study
The history or presence of any contraindications to the combined oral contraceptive tablet including thrombosis and the history of any thromboembolic disease, recurrent jaundice, acute or chronic liver disease, migraines, undiagnosed vaginal bleeding, significant hyperlipidemia, and mammary, endometrial, or hepatic carcinoma (known or suspected)
Participants determined to be unsuitable by the investigator for any reason

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.
Madison, Wisconsin

Other trials in United States

About this study

Official title: Effect of LY2216684 on Oral Contraceptive Pharmacokinetics in Healthy Female Subjects

Conditions: Depressive Disorder, Major
Being tested: LY2216684, Ortho Cyclen, Placebo
Medical subject headings: Depressive Disorder, Major

What participants receive

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

LY2216684Drug
Administered orally
Ortho CyclenDrug
35 micrograms (mcg) ethinyl estradiol and 250 mcg norgestimate administered orally
PlaceboDrug
Administered orally

Study groups in NCT01373931
Study group	Role	What they receive
OC + LY2216684 First, Then OC + Placebo	Experimental	28-day lead-in period of Ortho Cyclen (OC; 28-day packet), followed by randomization to OC administered orally once daily for 28 days + 18 milligrams (mg) of LY2216684 administered concomitantly orally once daily for 21 days, followed by OC administered orally once daily for 28 days + placebo administered concomitantly orally once daily for 21 days. Receives: Drug: LY2216684; Drug: Ortho Cyclen; Drug: Placebo
OC + Placebo First, Then OC + LY2216684	Experimental	28-day lead-in period of OC (28-day packet), followed by randomization to OC administered orally once daily for 28 days + placebo administered concomitantly orally once daily for 21 days, followed by OC administered orally once daily for 28 days + 18 mg of LY2216684 administered concomitantly orally once daily for 21 days. Receives: Drug: LY2216684; Drug: Ortho Cyclen; Drug: Placebo

What is being measured

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

Pharmacokinetics: Maximum Plasma Concentration (Cmax) of Ethinyl Estradiol and Norelgestromin
The results presented are Geometric Least Squares (LS) mean. LS mean values were adjusted for treatment, sequence, period and participant.
Measured: Predose up to 24 hours post dose on Day 21
Pharmacokinetics: Time to Maximum Plasma Concentration (Tmax) of Ethinyl Estradiol and Norelgestromin
Measured: Predose up to 24 hours post dose on Day 21
Area Under the Concentration-Time Curve Over a Dosing Interval (AUCτ) of Ethinyl Estradiol and Norelgestromin
The results presented are Geometric Least Squares (LS) mean. LS mean values were adjusted for treatment, sequence, period and participant.
Measured: Predose up to 24 hours post dose on Day 21

Timeline

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

Jun 2011Dec 2011

First posted15 Jun 2011 (estimated)
Study startJun 2011
Primary completionDec 2011
Study completionDec 2011

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 Depressive Disorder, MajorStudies 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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01373931
Sponsor's protocol ID: 12615
Other IDs: H9P-EW-LNCX
Status last verified: Mar 2018
First submitted: 13 Jun 2011
Last updated: 23 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 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of LY2216684 on Oral Contraceptive Pharmacokinetics in Healthy Female Subjects
ClinicalTrials.gov ID: NCT01373931
Acronym / sponsor ID: 12615
Conditions: Depressive Disorder, Major
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Jun 2011
Primary completion: Dec 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 15 Jun 2011 (estimated)
Results: Posted 23 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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
OC + LY2216684 First, Then OC + Placebo	Experimental	Drug: LY2216684, Drug: Ortho Cyclen, Drug: Placebo28-day lead-in period of Ortho Cyclen (OC; 28-day packet), followed by randomization to OC administered orally once daily for 28 days + 18 milligrams (mg) of LY2216684 administered concomitantly orally once daily for 21 days, followed by OC administered orally once daily for 28 days + placebo administered concomitantly orally once daily for 21 days.
OC + Placebo First, Then OC + LY2216684	Experimental	Drug: LY2216684, Drug: Ortho Cyclen, Drug: Placebo28-day lead-in period of OC (28-day packet), followed by randomization to OC administered orally once daily for 28 days + placebo administered concomitantly orally once daily for 21 days, followed by OC administered orally once daily for 28 days + 18 mg of LY2216684 administered concomitantly orally once daily for 21 days.

Who may qualify

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

Key inclusion criteria (8 listed)

Are overtly healthy females, as determined by medical history and physical examination
As it is possible that LY2216684 may cause the oral contraceptive tablet to be less effective than usual, participants will be required in addition to use double barrier methods of contraception from the Screening until 2 months after the post study follow-up. Additional barrier methods of contraception may include the following: a non-hormonal intrauterine device with spermicide; female condom with spermicide; contraceptive sponge with spermicide; diaphragm with spermicide; cervical cap with spermicide; a male sexual partner who agrees to use a male condom with spermicide; a sterile sexual partner; or abstinence (participants reporting abstinence who become sexually active while on the study must agree to use other additional barrier methods of contraception). The pregnancy test result must be negative at Screening and at each Check-in
Have a body weight of >50 kilograms (kg)
Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
Have venous access sufficient to allow for blood sampling as per the protocol

Key exclusion criteria (21 listed)

Are currently enrolled in, have completed or discontinued within the last 30 days from, a clinical trial involving an investigational product other than the investigational product used in this study, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Have known allergies to Ortho Cyclen, LY2216684, or related compounds
Are participants who have previously completed or withdrawn from this study or any other study investigating LY2216684 within 6 months prior to Screening
Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data

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
LY2216684Administered orally	Drug	OC + LY2216684 First, Then OC + Placebo, OC + Placebo First, Then OC + LY2216684
Ortho Cyclen35 micrograms (mcg) ethinyl estradiol and 250 mcg norgestimate administered orally	Drug	OC + LY2216684 First, Then OC + Placebo, OC + Placebo First, Then OC + LY2216684
PlaceboAdministered orally	Drug	OC + LY2216684 First, Then OC + Placebo, OC + Placebo First, Then OC + LY2216684

Primary outcome

Pharmacokinetics: Maximum Plasma Concentration (Cmax) of Ethinyl Estradiol and Norelgestromin
Time frame: Predose up to 24 hours post dose on Day 21
The results presented are Geometric Least Squares (LS) mean. LS mean values were adjusted for treatment, sequence, period and participant.
Pharmacokinetics: Time to Maximum Plasma Concentration (Tmax) of Ethinyl Estradiol and Norelgestromin
Time frame: Predose up to 24 hours post dose on Day 21
Area Under the Concentration-Time Curve Over a Dosing Interval (AUCτ) of Ethinyl Estradiol and Norelgestromin
Time frame: Predose up to 24 hours post dose on Day 21
The results presented are Geometric Least Squares (LS) mean. LS mean values were adjusted for treatment, sequence, period and participant.

Results and safety

Results posted to the registry on 23 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
OC + LY2216684 / OC + Placebo	10	8
OC + Placebo / OC + LY2216684	10	10

Primary outcome: Pharmacokinetics: Maximum Plasma Concentration (Cmax) of Ethinyl Estradiol and Norelgestromin

Time frame: Predose up to 24 hours post dose on Day 21. Geometric mean (90% Confidence Interval). Unit: picograms/milliliter (pg/mL)

Measure	OC + LY2216684 n = 14	OC + Placebo n = 16
Ethinyl Estradiol	79.0 (70.0 to 89.1)	80.9 (71.8 to 91.2)
Norelgestromin	1438 (1301 to 1589)	1574 (1427 to 1735)

OC + LY2216684 vs OC + Placebo: Ratio of Geometric LS Mean: 0.976 (90% CI 0.907 to 1.05), Mixed Models Analysis
OC + LY2216684 vs OC + Placebo: Ratio of Geometric LS Mean: 0.914 (90% CI 0.842 to 0.991), Mixed Models Analysis

Population analysed: All randomized participants who received at least 1 dose of study drug and had pharmacokinetics data to analyze Cmax. Participants were analyzed based on the treatment they received.

Primary outcome: Pharmacokinetics: Time to Maximum Plasma Concentration (Tmax) of Ethinyl Estradiol and Norelgestromin

Time frame: Predose up to 24 hours post dose on Day 21. Median (Full Range). Unit: hour (h)

Measure	OC + LY2216684 n = 14	OC + Placebo n = 14
Ethinyl Estradiol	2.00 (1.50 to 4.00)	2.00 (1.50 to 4.00)
Norelgestromin	3.00 (1.50 to 4.00)	2.03 (1.50 to 4.07)

OC + LY2216684 vs OC + Placebo: Median Difference (Final Values): -0.25 (90% CI -0.73 to 0.51), Wilcoxon Signed Rank Test
OC + LY2216684 vs OC + Placebo: Median Difference (Final Values): 0.00 (90% CI -0.50 to 0.50), Wilcoxon Signed Rank Test

Population analysed: All randomized participants who received at least 1 dose of study drug and had pharmacokinetics data to analyze tmax. Participants were analyzed based on the treatment they received.

Primary outcome: Area Under the Concentration-Time Curve Over a Dosing Interval (AUCτ) of Ethinyl Estradiol and Norelgestromin

Time frame: Predose up to 24 hours post dose on Day 21. Geometric mean (90% Confidence Interval). Unit: picograms*hour/milliliter (pg*hr/mL)

Measure	OC + LY2216684 n = 14	OC + Placebo n = 16
Ethinyl Estradiol	888 (799 to 987)	827 (744 to 918)
Norelgestromin	16156 (14626 to 17846)	16079 (14575 to 17738)

OC + LY2216684 vs OC + Placebo: Ratio of Geometric LS Mean: 1.07 (90% CI 1.00 to 1.15), Mixed Models Analysis
OC + LY2216684 vs OC + Placebo: Ratio of Geometric LS Mean: 1.00 (90% CI 0.944 to 1.07), Mixed Models Analysis

Population analysed: All randomized participants who received at least 1 dose of study drug and had pharmacokinetics data to analyze AUCτ. Participants were analyzed based on the treatment they received.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
OC Lead-in Period	0 of 18 (0%)	12 of 18 (66.7%)	Not reported
OC + LY2216684	0 of 16 (0%)	13 of 16 (81.3%)	Not reported
OC + Placebo	0 of 16 (0%)	13 of 16 (81.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 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 LY2216684 and Ortho Cyclen in people with Depressive Disorder, Major, 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 8 inclusion and 21 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 23 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 23 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: Maximum Plasma Concentration (Cmax) of Ethinyl Estradiol and Norelgestromin (time frame: Predose up to 24 hours post dose on Day 21). The study lists 3 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 NCT01373931.

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 23 Oct 2018.