A Safety Study of LY2886721 Single Doses in Healthy Subjects

Lilly

Status and phase: Completed; Phase 1

Conditions: Alzheimer's Disease

Treatments: Drug: LY2886721; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01133405

I4O-MC-BACA (Other Identifier)

13733

Details and patient eligibility

About

This is a Phase 1 study in healthy subjects to evaluate the safety and tolerability of LY2886721 single doses, how the body handles the drug, and the drug's effect on the body.

Full description

This is a Phase 1 study with 2 parts, both in healthy subjects. Part 1 is a subject- and investigator-blind, placebo-controlled, randomized, 3-period, crossover study. Part 1 will assess the safety and tolerability of LY2886721 single doses, how the body handles the drug, and the drug's effect on the body. Part 2 is a subject- and investigator-blind, placebo-controlled, randomized study to assess the safety and tolerability of an LY2886721 single dose, how the body handles the drug, and the drug's effect on the body including in cerebrospinal fluid.

Enrollment: 40 patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy men and nonchild-bearing potential women
• 20 years or older
• Body mass index between 18-32 kilograms per square meter (kg/m^2)

Exclusion criteria

• Taking over-the-counter or prescription medication with the exception of vitamins or minerals or stable doses of thyroid or estrogen hormone replacement
• Smoke more than 10 cigarettes per day

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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40 participants in 5 patient groups, including a placebo group

LY2886721 Part 1: Cohort A/B

Experimental group

Description:

Single (7 milligram (mg), 15 mg, 25 mg, 35 mg) doses of LY2886721 administered orally in up to three of three study periods

Treatment:

Drug: LY2886721

Placebo Part 1: Cohort A/B

Placebo Comparator group

Description:

Single dose in up to 1 period

Treatment:

Drug: Placebo

LY2886721 Part 2: Cohort C

Experimental group

Description:

Single 10 mg dose of LY2886721, dose determined by Part 1

Treatment:

Drug: LY2886721

LY2886721 Part 2: Cohort D

Experimental group

Description:

Single 35 mg dose of LY2886721, dose determined by Part 1

Treatment:

Drug: LY2886721

Placebo Part 2: Cohort C/D

Placebo Comparator group

Description:

Single dose

Treatment:

Drug: Placebo