A Safety Study of LY2886721 Single Doses in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01133405
First received: May 27, 2010
Last updated: November 4, 2010
Last verified: November 2010
  Purpose

This is a Phase 1 study in healthy subjects to evaluate the safety and tolerability of LY2886721 single 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: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Single-Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of LY2886721 in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Number of participants with Clinically Significant Effects [ Time Frame: Predose to 10-14 days after final dose of study drug ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Plasma concentrations of LY2886721 (Cmax) [ Time Frame: Predose and up to Day 8 of each period ] [ Designated as safety issue: No ]
  • Plasma concentration of LY2886721 (AUC) [ Time Frame: Predose and up to Day 8 of each period ] [ Designated as safety issue: No ]
  • Pharmacodynamic biomarker plasma Abeta 1-40 concentration [ Time Frame: Predose and up to Day 8 of each period ] [ Designated as safety issue: No ]
  • Cerebrospinal fluid (CSF) concentration of LY2886721 (Cmax) (Part 2 only) [ Time Frame: Predose and up to 36 hours postdose ] [ Designated as safety issue: No ]
  • Cerebrospinal fluid (CSF) Pharmacodynamic biomarker Abeta 1-40 concentration (Part 2 only) [ Time Frame: Predose and up to 36 hours postdose ] [ Designated as safety issue: No ]
  • Cerebrospinal fluid (CSF) concentration of LY2886721 (AUC) (Part 2 only) [ Time Frame: Predose and up to 36 hours postdose ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: June 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2886721 Part 1
Up to 3 single doses will be administered over 3 periods (each period is 8 days) in a crossover fashion either LY:LY:LY or LY:LY:Placebo in random order with variable doses ranging from 1 mg up to 200 mg
Drug: LY2886721
Oral capsules
Placebo Comparator: Placebo Part 1
Single dose in up to 1 period (the period is 8 days)
Drug: Placebo
Oral capsules
Experimental: LY2886721 Part 2 low dose
Single dose of LY2886721, dose determined by Part 1
Drug: LY2886721
Oral capsules
Experimental: LY2886721 Part 2 high dose
Single dose of LY2886721, dose determined by Part 1
Drug: LY2886721
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 LY2886721 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 an LY2886721 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 and older
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 18-32 kg/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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01133405

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.
Beverly Hills, California, United States, 90211
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: NCT01133405     History of Changes
Other Study ID Numbers: 13733, I4O-MC-BACA
Study First Received: May 27, 2010
Last Updated: November 4, 2010
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 July 20, 2014