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A Study of LY2886721 in Healthy Participants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01534273
First received: February 13, 2012
Last updated: August 9, 2012
Last verified: August 2012
  Purpose

The purpose of this phase I study in healthy participants will be to evaluate the safety and tolerability of LY2886721 single and multiple doses, how the body handles the drug and the drug's effect on the body.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Single- and Multiple-Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of LY2886721 in Healthy Subjects

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Number of participants with clinically significant effects [ Time Frame: Predose up to Day 23 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics: Plasma maximum observed concentration at steady state (Cmax,ss) of LY2886721 [ Time Frame: Predose up to Day 19 ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Plasma area under the concentration versus time curve (AUC) of LY2886721 [ Time Frame: Predose up to Day 19 ] [ Designated as safety issue: No ]
  • Change from baseline in cerebrospinal fluid (CSF) amyloid 1-40 concentration at Day 15 [ Time Frame: Baseline, Day 15 ] [ Designated as safety issue: No ]
  • Change from baseline in cerebrospinal fluid (CSF) amyloid 1-40 concentration at 24 hours post-dose [ Time Frame: Baseline, 24 hours post-dose ] [ Designated as safety issue: No ]

Estimated Enrollment: 39
Study Start Date: February 2012
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Single oral dose and/or once daily oral dosing for 14 consecutive days
Drug: Placebo
Administered orally.
Experimental: 35 mg LY2886721
Once daily oral dosing for 14 consecutive days
Drug: LY2886721
Administered orally.
Experimental: 70 mg LY2886721
Single oral dose followed by once daily oral dosing for 14 consecutive days
Drug: LY2886721
Administered orally.
Experimental: 140 mg LY2886721
Single oral dose
Drug: LY2886721
Administered orally.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy men and non-childbearing potential women
  • Body mass index between 18.0-32.0 kg/m^2
  • Are reliable and willing to make yourself available for the duration of the study and are willing to follow study procedures and research unit policies

Exclusion Criteria:

  • Taking over-the-counter or prescription medication with the exception of vitamins or minerals
  • Smoke more than 10 cigarettes per day
  • Drink more than 5 cups of caffeine containing beverages (e.g., coffee, tea) 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: NCT01534273

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.
Glendale, California, United States, 91206
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: NCT01534273     History of Changes
Other Study ID Numbers: 14464, I4O-MC-BACJ
Study First Received: February 13, 2012
Last Updated: August 9, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Mild Cognitive Impairment

ClinicalTrials.gov processed this record on November 27, 2014