A Safety Study of LY2811376 Single Doses in Healthy Subjects

NCT00838084 | Completed Phase 1

• 2 other identifiers: 12852I3J-MC-LACE
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• Clinical Effects

  Predose and up to Day 6 of each period

Secondary Outcomes (6)

• 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

Study Arms (5)

LY2811376 Part 1

EXPERIMENTAL

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

Drug: LY2811376

Placebo Part 1

PLACEBO COMPARATOR

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

Drug: Placebo

LY2811376 - Part 2 low dose

EXPERIMENTAL

Single dose of LY2811376, dose determined by part 1

Drug: LY2811376

LY2811376 - Part 2 high dose

EXPERIMENTAL

Single dose of LY2811376, dose determined by part 1

Drug: LY2811376

Placebo Part 2

PLACEBO COMPARATOR

single dose

Drug: Placebo

Interventions

LY2811376 DRUG

Oral capsules

LY2811376 - Part 2 high dose; LY2811376 - Part 2 low dose; LY2811376 Part 1

Placebo DRUG

Oral capsules

Placebo Part 1; Placebo Part 2

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (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

Location

Related Publications (1)

• Portelius E, Dean RA, Andreasson U, Mattsson N, Westerlund A, Olsson M, Demattos RB, Racke MM, Zetterberg H, May PC, Blennow K. beta-site amyloid precursor protein-cleaving enzyme 1(BACE1) inhibitor treatment induces Abeta5-X peptides through alternative amyloid precursor protein cleavage. Alzheimers Res Ther. 2014 Nov 17;6(5-8):75. doi: 10.1186/s13195-014-0075-0. eCollection 2014.

  PMID: 25404952 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Interventions

LY2811376

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 23, 2009
• First Posted: February 6, 2009
• Study Start: December 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: July 15, 2009

Record last verified: 2009-07

Locations

US (1)