Trial record 3 of 7 for:    LY2886721

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01807026
First received: March 6, 2013
Last updated: May 31, 2013
Last verified: May 2013
  Purpose

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 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.


Condition Intervention Phase
Alzheimer Disease
Healthy Volunteers
Drug: LY2886721
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: A Safety, Pharmacokinetic, and Pharmacodynamic Study of LY2886721 in Healthy Subjects and Patients Diagnosed With Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Pharmacokinetics: Area Under the Curve Extrapolated to Infinity (AUC0-∞) of Plasma LY2886721 [ Time Frame: Predose up to 96 hours after administration of study drug ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Maximum Concentration (Cmax) of Plasma LY2886721 [ Time Frame: Predose up to 96 hours after administration of study drug ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Maximum Concentration (Cmax) of CSF LY2886721 [ Time Frame: Predose up to 36 hours after administration of study drug ] [ Designated as safety issue: No ]
  • Pharmacodynamics (PD): Cnadir of Plasma Amyloid β (Aβ)1-40 [ Time Frame: Predose up to 96 hours after administration of study drug ] [ Designated as safety issue: No ]
  • PD: Cnadir of CSF Aβ 1-40 [ Time Frame: Predose up to 36 hours after administration of study drug ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cohort C: Mean QTcF Value at Cmax [ Time Frame: Predose up to 48 hours after administration of study drug ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: March 2013
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort A - LY2886721
Alzheimer's disease (AD) participants will receive a 70 mg single oral dose of LY2886721.
Drug: LY2886721
Administered orally
Placebo Comparator: Cohort A - Placebo
AD participants will receive a single oral dose of placebo.
Drug: Placebo
Administered orally
Experimental: Cohort B - LY2886721
Healthy participants will receive a single 70 mg oral dose of LY2886721.
Drug: LY2886721
Administered orally
Placebo Comparator: Cohort B - Placebo
Healthy participants will receive a single oral dose of placebo.
Drug: Placebo
Administered orally
Experimental: Cohort C - LY2886721
Healthy participants will receive a single oral ascending dose of LY2886721 in at least 2 of 3 study periods.
Drug: LY2886721
Administered orally
Placebo Comparator: Cohort C - Placebo
Healthy participants will receive a single oral dose of placebo in up to 1 of 3 study periods.
Drug: Placebo
Administered orally

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 AD
  • Healthy participants should not be taking any concomitant medications. For participants with AD, 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, physical examination and a diagnosis of AD 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 AD; 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, 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:

  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: NCT01807026

Locations
United States, Utah
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.
Salt Lake City, Utah, United States
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: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01807026     History of Changes
Other Study ID Numbers: 15107, I4O-EW-BACX
Study First Received: March 6, 2013
Last Updated: May 31, 2013
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 24, 2014