A Study of LY2969822 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: LY2969822; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02018887

15259

I4W-FW-HMJD (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate how safe LY2969822 (study drug) is and whether it causes any side effects. The study will also measure how much of the study drug gets into the blood stream and how long it takes the body to get rid of the study drug. This is the first time that this study drug is being given to participants. This study is for research purposes only and is not intended to treat any medical condition.

Full description

Participants in Part A will complete three study periods, which together will last about 40 days. Participants in Parts B and C will complete one study period which will last about 17 days, but the total study time is about 40 days. Each participant may only enroll in one part. Screening is required within 28 days prior to the start of the study for all participants.

Enrollment: 99 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male participants must agree to use a reliable method of birth control in addition to having their partner use another method for the duration of the study and for 3 months after the last dose of LY2969822
• Female participants must not be of child-bearing potential
• Participants have a body mass index (BMI) of 18.5 to 29.9 kilogram per meter square (kg/m^2), inclusive, at screening

Exclusion criteria

• Have participated, within the last 30 days (prior to first dose in this study), in a clinical trial involving an investigational product
• Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), 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
• Intended use of over-the-counter medication within 14 days prior to dosing or during the study with the exception of vitamins and mineral supplements or occasional paracetamol or acetaminophen
• Intended use of herbal supplements or prescription medications, other than stable doses of thyroid or estrogen hormone replacement, within 14 days prior to dosing or during the study

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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99 participants in 6 patient groups, including a placebo group

LY2969822 (Part A)

Experimental group

Description:

Single dose of LY2969822 administered orally in 2 of 3 study periods.

Treatment:

Drug: LY2969822

Placebo (Part A)

Placebo Comparator group

Description:

Single dose of placebo administered orally in 1 of 3 study periods.

Treatment:

Drug: Placebo

LY2969822 (Part B)

Experimental group

Description:

LY2969822 administered orally for 14 days.

Treatment:

Drug: LY2969822

Placebo (Part B)

Placebo Comparator group

Description:

Placebo administered orally for 14 days.

Treatment:

Drug: Placebo

LY2969822 (Part C)

Experimental group

Description:

LY2969822 administered orally for 14 days.

Treatment:

Drug: LY2969822

Placebo (Part C)

Placebo Comparator group

Description:

Placebo administered orally for 14 days.

Treatment:

Drug: Placebo