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A Safety Study of LY2886721 Multiple Doses in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01227252
First received: October 21, 2010
Last updated: May 9, 2011
Last verified: May 2011
History of Changes
  Purpose

This is a Phase 1 study in healthy subjects to evaluate the safety and tolerability of LY2886721 multiple doses, how the body handles the drug, and the drug's effect on the body.


Condition Intervention Phase
Alzheimer's Disease
 Drug: LY2886721
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Multiple-Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of LY2886721 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:
  • Number of participants with Clinically Significant Effects [ Time Frame: Predose up to Day 70 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Plasma maximum observed drug concentration at steady state (Cmax,ss) of LY2886721 [ Time Frame: Predose up to Day 19 ] [ Designated as safety issue: No ]
  • Plasma area under the concentration versus time curve (AUC) of LY2886721 [ Time Frame: Predose up to Day 19 ] [ Designated as safety issue: No ]
  • Plasma Abeta 1-40 concentration [ Time Frame: Predose up to Day 23 ] [ Designated as safety issue: No ]
  • Cerebrospinal fluid (CSF) concentration of LY2886721 [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
  • Change from baseline to Day 15 endpoint in cerebrospinal fluid (CSF) Abeta 1-40 concentration [ Time Frame: Predose and Day 15 ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: December 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2886721 Drug: LY2886721
5 mg up to 35 mg, administered orally as capsules, daily for 14 days
Placebo Comparator: Placebo Drug: Placebo
Administered orally as capsules, daily for 14 days

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy men and non-childbearing potential women
  • Body mass index between 18.0-32.0 kg/m2
  • Are reliable and willing to make yourself available for the duration of the study and are willing to follow study procedures and research unit policies

Exclusion Criteria:

  • Taking over-the-counter or prescription medication with the exception of vitamins or minerals
  • Smoke more than 10 cigarettes per day
  • Drink more than 5 cups of caffeine containing beverages (e.g., coffee, tea) per day
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01227252

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, 91206
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: NCT01227252     History of Changes
Other Study ID Numbers: 13734, I4O-MC-BACB
Study First Received: October 21, 2010
Last Updated: May 9, 2011
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