A Safety Study of LY2811376 Single Doses in Healthy Subjects

Phase 1

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: LY2811376; Drug: Placebo

• Registration Number: NCT00838084
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-01-23
• Study First Submitted QC: 2009-02-05
• Study First Posted: 2009-02-06
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-14
• Last Update Posted: 2009-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LY2811376 Part 1	LY2811376	LY2811376 (5 mg up to 500 mg); once a day or twice a day for 1 day in up to 3 periods.
Placebo Part 1	Placebo	once a day or twice a day for 1 day in up to 3 periods.
LY2811376 - Part 2 low dose	LY2811376	Single dose of LY2811376, dose determined by part 1
LY2811376 - Part 2 high dose	LY2811376	Single dose of LY2811376, dose determined by part 1
Placebo Part 2	Placebo	single dose

Primary Outcome Measures

Name	Time	Method
Clinical Effects	Predose and up to Day 6 of each period

Secondary Outcome Measures

Name	Time	Method
Plasma concentration of LY2811376 (Cmax)	Predose and up to Day 6 of each period
Plasma concentration of LY2811376 (AUC)	Predose and up to Day 6 of each period
Amyloid beta 1-40 plasma concentrations	Predose and up to Day 6 of each period
Cerebrospinal fluid (CSF) concentration of LY2811376 (Cmax) (Part 2 only)	Predose and up to 36 hours
Cerebrospinal fluid (CSF) concentration of LY2811376 (AUC) (Part 2 only)	Predose and up to 36 hours
Amyloid beta 1-40 cerebrospinal fluid CSF concentrations (Part 2 only)	Predose and up to 36 hours

Trial Locations

Locations (1)

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.; 🇺🇸 Glendale, California, United States