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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

May 27, 2010
November 4, 2010
June 2010
October 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01133405 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Safety Study of LY2886721 Single Doses in Healthy Subjects
Single-Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of LY2886721 in Healthy Subjects

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Alzheimer's Disease
  • Drug: LY2886721
    Oral capsules
  • Drug: Placebo
    Oral capsules
  • 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
    Intervention: Drug: LY2886721
  • Placebo Comparator: Placebo Part 1
    Single dose in up to 1 period (the period is 8 days)
    Intervention: Drug: Placebo
  • Experimental: LY2886721 Part 2 low dose
    Single dose of LY2886721, dose determined by Part 1
    Intervention: Drug: LY2886721
  • Experimental: LY2886721 Part 2 high dose
    Single dose of LY2886721, dose determined by Part 1
    Intervention: Drug: LY2886721
  • Placebo Comparator: Placebo Part 2
    Single dose
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
0
October 2010
October 2010   (final data collection date for primary outcome measure)

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
Both
20 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01133405
13733, I4O-MC-BACA
No
Chief Medical Officer, Eli Lilly
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP