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A Safety Study of LY2811376 Single Doses in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00838084
First received: January 23, 2009
Last updated: July 14, 2009
Last verified: July 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
 Drug: LY2811376
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Single-Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of LY2811376 in Healthy Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Clinical Effects [ Time Frame: Predose and up to Day 6 of each period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Plasma concentration of LY2811376 (Cmax) [ Time Frame: Predose and up to Day 6 of each period ] [ Designated as safety issue: Yes ]
  • Plasma concentration of LY2811376 (AUC) [ Time Frame: Predose and up to Day 6 of each period ] [ Designated as safety issue: Yes ]
  • Amyloid beta 1-40 plasma concentrations [ Time Frame: Predose and up to Day 6 of each period ] [ Designated as safety issue: Yes ]
  • Cerebrospinal fluid (CSF) concentration of LY2811376 (Cmax) (Part 2 only) [ Time Frame: Predose and up to 36 hours ] [ Designated as safety issue: Yes ]
  • Cerebrospinal fluid (CSF) concentration of LY2811376 (AUC) (Part 2 only) [ Time Frame: Predose and up to 36 hours ] [ Designated as safety issue: Yes ]
  • Amyloid beta 1-40 cerebrospinal fluid CSF concentrations (Part 2 only) [ Time Frame: Predose and up to 36 hours ] [ Designated as safety issue: Yes ]

Enrollment: 61
Study Start Date: December 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2811376 Part 1
LY2811376 (5 mg up to 500 mg); once a day or twice a day for 1 day in up to 3 periods.
 Drug: LY2811376
Oral capsules
Placebo Comparator: Placebo Part 1
once a day or twice a day for 1 day in up to 3 periods.
 Drug: Placebo
Oral capsules
Experimental: LY2811376 - Part 2 low dose
Single dose of LY2811376, dose determined by part 1
 Drug: LY2811376
Oral capsules
Experimental: LY2811376 - Part 2 high dose
Single dose of LY2811376, dose determined by part 1
 Drug: LY2811376
Oral capsules
Placebo Comparator: Placebo Part 2
single dose
 Drug: Placebo
Oral capsules

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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00838084

Locations
United States, California
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
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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
  More Information

No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00838084     History of Changes
Other Study ID Numbers: 12852, I3J-MC-LACE
Study First Received: January 23, 2009
Last Updated: July 14, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 18, 2013