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A Study of LY2886721 in Healthy Participants and Participants Diagnosed With Alzheimer's Disease

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: NCT01807026
Recruitment Status : Completed
First Posted : March 8, 2013
Results First Posted : July 19, 2019
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE March 6, 2013
First Posted Date  ICMJE March 8, 2013
Results First Submitted Date  ICMJE May 9, 2019
Results First Posted Date  ICMJE July 19, 2019
Last Update Posted Date July 19, 2019
Study Start Date  ICMJE March 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
  • Pharmacokinetics: Area Under the Curve Extrapolated to Infinity (AUC0-∞) of Plasma LY2886721 [ Time Frame: Predose through 96 hours after administration of study drug ]
    AUC0-∞ following administration of a single dose of 70 or 280 mg LY2886721.
  • Pharmacokinetics: Maximum Concentration (Cmax) of Plasma LY2886721 [ Time Frame: Predose through 96 hours after administration of study drug ]
    Cmax following administration of a single dose of 70 or 280 mg LY2886721.
  • Pharmacokinetics: Area Under the Curve Extrapolated to Infinity (AUC0-∞) of Cerebrospinal Fluid (CSF) LY2886721 [ Time Frame: Predose through 36 hours after administration of study drug ]
    AUC0-∞ following administration of a single dose of 70 mg LY2886721.
  • Pharmacokinetics: Maximum Concentration (Cmax) of CSF LY2886721 [ Time Frame: Predose through 36 hours after administration of study drug ]
    Cmax following administration of a single dose of 70 mg LY2886721.
  • Pharmacodynamics (PD): Cnadir of Plasma Amyloid β (Aβ)1-40 [ Time Frame: Predose, up to 96 hours after administration of study drug ]
    Plasma concentration of Aβ1-40 was summarized based on lowest observed concentration (Cnadir).
  • PD: Cnadir of CSF Aβ 1-40 [ Time Frame: Predose up to 36 hours after administration of study drug ]
    Plasma concentration of Aβ1-40 was summarized based on Cnadir following administration of a single dose of 70 mg LY2886721 or a single dose of LY2886721-matching placebo.
Original Primary Outcome Measures  ICMJE
 (submitted: March 6, 2013)
  • Pharmacokinetics: Area Under the Curve Extrapolated to Infinity (AUC0-∞) of Plasma LY2886721 [ Time Frame: Predose up to 96 hours after administration of study drug ]
  • Pharmacokinetics: Maximum Concentration (Cmax) of Plasma LY2886721 [ Time Frame: Predose up to 96 hours after administration of study drug ]
  • Pharmacokinetics: Area Under the Curve Extrapolated to Infinity (AUC0-∞) of Cerebrospinal Fluid (CSF) LY2886721 [ Time Frame: Predose up to 36 hours after administration of study drug ]
  • Pharmacokinetics: Maximum Concentration (Cmax) of CSF LY2886721 [ Time Frame: Predose up to 36 hours after administration of study drug ]
  • Pharmacodynamics (PD): Cnadir of Plasma Amyloid β (Aβ)1-40 [ Time Frame: Predose up to 96 hours after administration of study drug ]
  • PD: Cnadir of CSF Aβ 1-40 [ Time Frame: Predose up to 36 hours after administration of study drug ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
Cohort C: Mean QTcF Value at Cmax [ Time Frame: Predose up to 48 hours after administration of study drug ]
The mean QTcF value at Cmax for participants administered a single dose of 280 mg LY2886721 was reported. The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. Time matched mean change from baseline in QTcF = time matched plasma concentration + participant + random error.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2013)
Cohort C: Mean QTcF Value at Cmax [ Time Frame: Predose up to 48 hours after administration of study drug ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of LY2886721 in Healthy Participants and Participants Diagnosed With Alzheimer's Disease
Official Title  ICMJE A Safety, Pharmacokinetic, and Pharmacodynamic Study of LY2886721 in Healthy Subjects and Patients Diagnosed With Alzheimer's Disease
Brief Summary

This study is being done for the following reasons:

To determine the safety of LY2886721 and any side effects that may be associated with it and to see how much of the study drug is in the blood and the cerebrospinal fluid (CSF) when one dose is given to healthy participants and participants diagnosed with Alzheimer's disease. It will also look at how safe and tolerable the study drug is when given to healthy participants in higher doses.

This research study is being conducted in three groups, referred to as Groups (Cohorts) A, B, or C.

Group A will enroll participants with Alzheimer's disease while Groups B and C will enroll healthy participants.

For Group A or B, participation in this research study could last up to 34 days. For Group C, participation could last up to 60 days.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE
  • Alzheimer Disease
  • Healthy Volunteers
Intervention  ICMJE
  • Drug: LY2886721
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Cohort A: 70 mg LY2886721
    Participants with Alzheimer's disease received a single, 70-milligrams (mg) (1 capsule), oral dose of LY2886721.
    Intervention: Drug: LY2886721
  • Placebo Comparator: Cohort A: Placebo
    Participants with Alzheimer's disease received a single, oral dose of LY2886721-matching placebo (1 capsule).
    Intervention: Drug: Placebo
  • Experimental: Cohort B: 70 mg LY2886721
    Healthy participants received a single, 70-mg (1 capsule), oral dose of LY2886721.
    Intervention: Drug: LY2886721
  • Placebo Comparator: Cohort B: Placebo
    Healthy participants received a single, oral dose of LY2886721-matching placebo (1 capsule).
    Intervention: Drug: Placebo
  • Experimental: Cohort C: 280 mg LY2886721
    Healthy participants received a single, 280-mg (4 x 70 mg capsules), oral dose of LY2886721.
    Intervention: Drug: LY2886721
  • Placebo Comparator: Cohort C: Placebo
    Healthy participants received a single, oral dose of LY2886721-matching placebo (4 capsules).
    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: March 6, 2013)
36
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy participants have a body mass index (BMI) of 19 to 32 kilograms per square meter (kg/m^2), inclusive, at screening. There are no restrictions on BMI in participants diagnosed with Alzheimer's disease.
  • Healthy participants should not be taking any concomitant medications. For participants with Alzheimer's disease, concomitant medications will be determined by the investigator in consultation with the Lilly clinical pharmacologist on an individual basis.

Cohort A:

  • Participants are defined as otherwise healthy males or females as determined by medical history and physical examination, and a diagnosis of Alzheimer's disease and must be at least 45 years of age.
  • Meets National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable Alzheimer's disease, as determined by a clinician approved by the sponsor or designee.
  • Mini Mental State Examination (MMSE) score of 16 through 28 at screening.
  • Modified Hachinski Ischemia Scale (MHIS) score of <4.
  • Capable of understanding and signing their own informed consent, in the opinion of the investigator, or if the participant has a Legally Authorized Representative (LAR), then the LAR must be capable of understanding and signing the assent form, and the participant may or may not sign the informed consent, as to be determined by the investigator.
  • If receiving concurrent treatment with an acetylcholinesterase inhibitor (AChEI) and/or memantine, the participant has been on a stable dose for at least 4 weeks before Day 1. Dosing must remain stable throughout the study. Note: If a participant has recently stopped ACHEIs and/or memantine, he or she must have discontinued treatment for at least 4 weeks before Day 1.

Exclusion Criteria:

  • Have an abnormality in the 12-lead electrocardiogram (ECG).
  • Have abnormal blood pressure.
  • Have abnormal thyroid function as reflected by thyroid stimulating hormone (TSH) values outside of the normal range.
  • Show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies.
  • Show evidence of hepatitis C and/or positive hepatitis C antibody.
  • Have had multiple episodes of head trauma, or have a history within the last 5 years of a serious infectious disease affecting the brain.
  • Have chronic hepatic disease.
  • Have evidence or history of significant active bleeding or a coagulation disorder.
  • Cohort A: have any neurological disorders other than Alzheimer's disease.
  • For healthy participants (Cohorts B and C) only: Use or intend to use over the- counter or prescription medication, including herbal medications within 14 days prior to dosing or during the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 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 NCT01807026
Other Study ID Numbers  ICMJE 15107
I4O-EW-BACX ( 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