A Safety Study of LY2811376 Single Doses in Healthy Subjects

Lilly

Status and phase: Completed; Phase 1

Conditions: Alzheimer's Disease

Treatments: Drug: Placebo; Drug: LY2811376

Study type: Interventional

Funder types: Industry

Identifiers

NCT00838084

I3J-MC-LACE

12852

Details and patient eligibility

About

This is a Phase 1 study in healthy subjects to evaluate the safety and tolerability of LY2811376 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 LY2811376 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 a LY2811376 single dose, how the body handles the drug, and the drug's effect on the body including in cerebrospinal fluid.

Enrollment: 61 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy men and nonchild-bearing potential women
• 20 years or older
• Body mass index between 18-32kg/m2

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.
• Consume more than 5 cups of coffee per day.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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61 participants in 5 patient groups, including a placebo group

LY2811376 Part 1

Experimental group

Description:

LY2811376 (5 mg up to 500 mg); once a day or twice a day for 1 day in up to 3 periods.

Treatment:

Drug: LY2811376

Placebo Part 1

Placebo Comparator group

Description:

once a day or twice a day for 1 day in up to 3 periods.

Treatment:

Drug: Placebo

LY2811376 - Part 2 low dose

Experimental group

Description:

Single dose of LY2811376, dose determined by part 1

Treatment:

Drug: LY2811376

LY2811376 - Part 2 high dose

Experimental group

Description:

Single dose of LY2811376, dose determined by part 1

Treatment:

Drug: LY2811376

Placebo Part 2

Placebo Comparator group

Description:

single dose

Treatment:

Drug: Placebo