A Study of LY2216684 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Major Depressive Disorder

Treatments: Drug: LY2216684; Drug: Placebo-matching alcoholic beverage; Drug: Alcoholic beverage; Drug: Placebo-matching LY2216684

Study type: Interventional

Funder types: Industry

Identifiers

NCT01380691

12613

H9P-EW-LNCV (Other Identifier)

Details and patient eligibility

About

This study will evaluate the pharmacodynamic and pharmacokinetic interaction of LY2216684 with alcohol in healthy participants. This study will run approximately for 34 days.

Enrollment: 28 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Overtly healthy male or female participants, as determined by medical history and physical examination
• Male participants: Agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug
• Female participants: Women of child-bearing potential who test negative for pregnancy at the time of enrollment, have used a reliable method of birth control for 6 weeks prior to administration of study drug, and agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug (hormonal methods of contraception, including oral and implantable contraceptives, are not allowed in this study) or women who are not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or due to menopause (at least 1 year without menses or 6 months without menses and a follicle stimulating hormone [FSH] >40 milli-international units/milliliter [mIU/mL])
• Male and female participants: Examples of reliable methods of birth control include double-barrier methods (for example, condom and spermicide) alone or in combination with vasectomy, vasectomized partners, and abstinence.
• Have a body weight >50 kilogram (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
• 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
• Have normal blood pressure and pulse rate (in sitting position) as determined by the investigator

Exclusion criteria

• Are currently enrolled in or have completed or discontinued within the last 30 days from a clinical trial involving an investigational product other than the study drug 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 LY2216684, related compounds or any components of the formulation
• Are persons who have previously received the investigational product in this study or have 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 of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders that are 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 of suicide attempt or ideation
• Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
• Participants with a past history of alcohol dependence/abuse
• Show evidence of human immunodeficiency virus (HIV) infection and/or positive 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
• Women with a positive pregnancy test or women who are lactating
• Intend to use over-the-counter or prescription medication within 14 days prior to dosing or during the study unless deemed acceptable by the investigator and Sponsor's medical monitor, except for influenza vaccinations
• Have donated blood of more than 500 milliliter (mL) within the last month
• Have an average weekly alcohol intake that exceeds 14 units per week, or are unwilling to stop alcohol consumption 48 hours prior to each study period and while resident at the Clinical Research Unit (CRU) (except as required per this protocol); (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 are unwilling to adhere to study caffeine restrictions
• Have consumed grapefruit or grapefruit-containing products 7 days prior to enrollment or are unwilling to abstain during the study
• Have a documented or suspected history of glaucoma
• Participants with known or suspected alcohol dehydrogenase deficiency
• Participants who do not drink alcohol and/or are not willing to drink 4 units of alcohol over a 15-minute period
• Participants determined to be unsuitable by the investigator for any reason

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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28 participants in 4 patient groups

LY, Alc, Pl-Match Alc, Then Pl-Match LY, Alc, Pl-Match Alc

Experimental group

Description:

Period 1: 18 milligrams (mg) LY2216684 (LY) administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of an alcoholic (Alc) beverage (with an alcohol dose of 0.6 grams per kilograms \[g/kg\] for women and 0.7 g/kg for men), taken orally, one time. On Day 8, participants were administered 2 cups of a placebo-matching (Pl-Match) alcoholic beverage, taken orally, one time. Period 2: Placebo-matching LY2216684 administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of an alcoholic beverage (with an alcohol dose of 0.6 g/kg for women and 0.7 g/kg for men), taken orally, one time. On Day 8, participants were administered 2 cups of a placebo-matching alcoholic beverage, taken orally, one time. There was a 7-day washout period between Periods 1 and 2.

Treatment:

Drug: Placebo-matching LY2216684

Drug: Alcoholic beverage

Drug: Placebo-matching alcoholic beverage

Drug: LY2216684

Pl-Match LY, Alc, Pl-Match Alc, Then LY, Alc, Pl-Match Alc

Experimental group

Description:

Period 1: Placebo-matching LY2216684 administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of an alcoholic beverage (with an alcohol dose of 0.6 g/kg for women and 0.7 g/kg for men), taken orally, one time. On Day 8, participants were administered 2 cups of a placebo-matching alcoholic beverage, taken orally, one time. Period 2: 18 mg LY2216684 administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of an alcoholic beverage (with an alcohol dose of 0.6 g/kg for women and 0.7 g/kg for men), taken orally, one time. On Day 8, participants were administered 2 cups of a placebo-matching alcoholic beverage, taken orally, one time. There was a 7-day washout period between Periods 1 and 2.

Treatment:

Drug: Placebo-matching LY2216684

Drug: Alcoholic beverage

Drug: Placebo-matching alcoholic beverage

Drug: LY2216684

LY, Pl-Match Alc, Alc, Then Pl-Match LY, Pl-Match Alc, Alc

Experimental group

Description:

Period 1: 18 mg LY2216684 administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of a placebo-matching alcoholic beverage, taken orally, one time. On Day 8, participants were administered 2 cups of an alcoholic beverage (with an alcohol dose of 0.6 g/kg for women and 0.7 g/kg for men), taken orally, one time. Period 2: Placebo-matching LY2216684 administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of a placebo-matching alcoholic beverage, taken orally, one time. On Day 8, participants were administered 2 cups of an alcoholic beverage (with an alcohol dose of 0.6 g/kg for women and 0.7 g/kg for men), taken orally, one time. There was a 7-day washout period between Periods 1 and 2.

Treatment:

Drug: Placebo-matching LY2216684

Drug: Alcoholic beverage

Drug: Placebo-matching alcoholic beverage

Drug: LY2216684

Pl-Match LY, Pl-Match Alc, Alc, Then LY, Pl-Match Alc, Alc

Experimental group

Description:

Period 1: Placebo-matching LY2216684 administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of a placebo-matching alcoholic beverage, taken orally, one time. On Day 8, participants were administered 2 cups of an alcoholic beverage (with an alcohol dose of 0.6 g/kg for women and 0.7 g/kg for men), taken orally, one time. Period 2: 18 mg LY2216684 administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of a placebo-matching alcoholic beverage, taken orally, one time. On Day 8, participants were administered 2 cups of an alcoholic beverage (with an alcohol dose of 0.6 g/kg for women and 0.7 g/kg for men), taken orally, one time. There was a 7-day washout period between Periods 1 and 2.

Treatment:

Drug: Placebo-matching LY2216684

Drug: Alcoholic beverage

Drug: Placebo-matching alcoholic beverage

Drug: LY2216684