A Safety Study of LY2811376 Single Doses in Healthy Subjects

Alzheimer's Disease Clinical Trial

Official title:

Single-Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of LY2811376 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00838084
• Other study ID #: 12852
• Secondary ID: I3J-MC-LACE
• Status: Completed
• Phase: Phase 1
• First received: January 23, 2009
• Last updated: July 14, 2009
• Start date: December 2008
• Est. completion date: June 2009

Study information

• Verified date: July 2009
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• LY2811376
Oral capsules
• Placebo
Oral capsules

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Effects		Predose and up to Day 6 of each period	Yes
Secondary	Plasma concentration of LY2811376 (Cmax)		Predose and up to Day 6 of each period	Yes
Secondary	Plasma concentration of LY2811376 (AUC)		Predose and up to Day 6 of each period	Yes
Secondary	Amyloid beta 1-40 plasma concentrations		Predose and up to Day 6 of each period	Yes
Secondary	Cerebrospinal fluid (CSF) concentration of LY2811376 (Cmax) (Part 2 only)		Predose and up to 36 hours	Yes
Secondary	Cerebrospinal fluid (CSF) concentration of LY2811376 (AUC) (Part 2 only)		Predose and up to 36 hours	Yes
Secondary	Amyloid beta 1-40 cerebrospinal fluid CSF concentrations (Part 2 only)		Predose and up to 36 hours	Yes