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A Safety Study of LY2886721 Single Doses in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01133405
Recruitment Status : Completed
First Posted : May 28, 2010
Results First Posted : September 16, 2019
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE May 27, 2010
First Posted Date  ICMJE May 28, 2010
Results First Submitted Date  ICMJE May 20, 2019
Results First Posted Date  ICMJE September 16, 2019
Last Update Posted Date September 16, 2019
Study Start Date  ICMJE June 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 13, 2019)
Number of Participants With Clinically Significant Effects (Adverse Events) [ Time Frame: Predose to 10-14 days after final dose of study drug (up to 42 days) ]
A summary of serious adverse events and other nonserious adverse events located in Reported Adverse Event section. To assess effect of food on pharmacokinetics of LY2886721, participants in Cohort B during Period 3 (1 period=8 days) of Part 1 fasted overnight for at least 8 hours prior to receiving a single 7-milligram (mg) oral dose of LY2886721 in the fed state (Part 1 - Fed). Participants in other LY2886721 groups received LY2886721 in fasted state. Due to crossover design in Part 1, results reported by treatment; thus, participants are included in multiple arms.
Original Primary Outcome Measures  ICMJE
 (submitted: May 27, 2010)
Number of participants with Clinically Significant Effects [ Time Frame: Predose to 10-14 days after final dose of study drug ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 13, 2019)
  • Maximum Observed Plasma Concentration (Cmax) of LY2886721 [ Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60 and 96 hours post-dose ]
    To assess effect of food on pharmacokinetics of LY2886721, participants in Cohort B during Period 3 (1 period=8 days) of Part 1 fasted overnight for at least 8 hours prior to receiving a single 7-milligram (mg) oral dose of LY2886721 in the fed state (Part 1 - Fed). Participants in the other LY2886721 groups received LY2886721 in the fasted state. Due to the crossover design in Part 1, results are reported by treatment; therefore, participants are included in multiple arms.
  • Plasma Concentration of LY2886721: Area Under the Concentration Versus Time Curve (AUC) [ Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60 and 96 hours post-dose ]
    Pharmacokinetic AUC for LY2886721 from time 0 to infinity. To assess effect of food on pharmacokinetics of LY2886721, participants in Cohort B during Period 3 (1 period=8 days) of Part 1 fasted overnight for at least 8 hours prior to receiving a single 7-milligram (mg) oral dose of LY2886721 in the fed state (Part 1 - Fed). Participants in the other LY2886721 groups received LY2886721 in the fasted state. Due to the crossover design in Part 1, results are reported by treatment; therefore, participants are included in multiple arms.
  • Pharmacodynamic Biomarker: Plasma Amyloid Beta (Aβ) 1-40 Concentration (Part 1 Only) [ Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60 and 96 hours post-dose ]
    Plasma concentrations of Aβ1-40 were based on the lowest observed/measured concentration (Cnadir). To assess effect of food on pharmacokinetics of LY2886721, participants in Cohort B during Period 3 (1 period=8 days) of Part 1 fasted overnight for at least 8 hours prior to receiving a single 7-milligram (mg) oral dose of LY2886721 in the fed state (Part 1 - Fed). Participants in the other LY2886721 groups received LY2886721 in the fasted state. Due to the crossover design in Part 1, results are reported by treatment; therefore, participants are included in multiple arms.
  • Cerebrospinal Fluid (CSF) Maximum Observed Drug Concentration (Cmax) of LY2886721 (Part 2 Only) [ Time Frame: Predose and up to 36 hours postdose ]
  • Cerebrospinal Fluid (CSF) Pharmacodynamic Biomarker Amyloid Beta (Aβ) 1-40 Concentration (Part 2 Only) [ Time Frame: Predose and up to 36 hours postdose ]
    CSF Aβ 1-40 concentration was based on the lowest observed/measured concentration (Cnadir).
  • Cerebrospinal Fluid (CSF) Area Under the Concentration Versus Time Curve (AUC) of LY2886721 (Part 2 Only) [ Time Frame: Predose and up to 36 hours postdose ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2010)
  • Plasma concentrations of LY2886721 (Cmax) [ Time Frame: Predose and up to Day 8 of each period ]
  • Plasma concentration of LY2886721 (AUC) [ Time Frame: Predose and up to Day 8 of each period ]
  • Pharmacodynamic biomarker plasma Abeta 1-40 concentration [ Time Frame: Predose and up to Day 8 of each period ]
  • Cerebrospinal fluid (CSF) concentration of LY2886721 (Cmax) (Part 2 only) [ Time Frame: Predose and up to 36 hours postdose ]
  • Cerebrospinal fluid (CSF) Pharmacodynamic biomarker Abeta 1-40 concentration (Part 2 only) [ Time Frame: Predose and up to 36 hours postdose ]
  • Cerebrospinal fluid (CSF) concentration of LY2886721 (AUC) (Part 2 only) [ Time Frame: Predose and up to 36 hours postdose ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety Study of LY2886721 Single Doses in Healthy Subjects
Official Title  ICMJE Single-Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of LY2886721 in Healthy Subjects
Brief Summary 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE
  • Drug: LY2886721
    Oral capsules
  • Drug: Placebo
    Oral capsules
Study Arms  ICMJE
  • Experimental: LY2886721 Part 1: Cohort A/B
    Single (7 milligram (mg), 15 mg, 25 mg, 35 mg) doses of LY2886721 administered orally in up to three of three study periods
    Intervention: Drug: LY2886721
  • Placebo Comparator: Placebo Part 1: Cohort A/B
    Single dose in up to 1 period
    Intervention: Drug: Placebo
  • Experimental: LY2886721 Part 2: Cohort C
    Single 10 mg dose of LY2886721, dose determined by Part 1
    Intervention: Drug: LY2886721
  • Experimental: LY2886721 Part 2: Cohort D
    Single 35 mg dose of LY2886721, dose determined by Part 1
    Intervention: Drug: LY2886721
  • Placebo Comparator: Placebo Part 2: Cohort C/D
    Single dose
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 13, 2019)
40
Original Estimated Enrollment  ICMJE
 (submitted: May 27, 2010)
50
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy men and nonchild-bearing potential women
  • 20 years or older
  • Body mass index between 18-32 kilograms per square meter (kg/m^2)

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01133405
Other Study ID Numbers  ICMJE 13733
I4O-MC-BACA ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date May 2019

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