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A Safety Study of LY2811376 Single Doses in Healthy Subjects

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
LY2811376
Placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Alzheimer's Disease

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy men and nonchild-bearing potential women
  • 20 years or older
  • Body mass index between 18-32kg/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.
  • Consume more than 5 cups of coffee per day.

Sites / Locations

  • 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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Experimental

Experimental

Placebo Comparator

Arm Label

LY2811376 Part 1

Placebo Part 1

LY2811376 - Part 2 low dose

LY2811376 - Part 2 high dose

Placebo Part 2

Arm Description

LY2811376 (5 mg up to 500 mg); once a day or twice a day for 1 day in up to 3 periods.

once a day or twice a day for 1 day in up to 3 periods.

Single dose of LY2811376, dose determined by part 1

Single dose of LY2811376, dose determined by part 1

single dose

Outcomes

Primary Outcome Measures

Clinical Effects

Secondary Outcome Measures

Plasma concentration of LY2811376 (Cmax)
Plasma concentration of LY2811376 (AUC)
Amyloid beta 1-40 plasma concentrations
Cerebrospinal fluid (CSF) concentration of LY2811376 (Cmax) (Part 2 only)
Cerebrospinal fluid (CSF) concentration of LY2811376 (AUC) (Part 2 only)
Amyloid beta 1-40 cerebrospinal fluid CSF concentrations (Part 2 only)

Full Information

First Posted
January 23, 2009
Last Updated
July 14, 2009
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00838084
Brief Title
A Safety Study of LY2811376 Single Doses in Healthy Subjects
Official Title
Single-Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of LY2811376 in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a Phase 1 study in healthy subjects to evaluate the safety and tolerability of LY2811376 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 LY2811376 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 a LY2811376 single dose, how the body handles the drug, and the drug's effect on the body including in cerebrospinal fluid.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LY2811376 Part 1
Arm Type
Experimental
Arm Description
LY2811376 (5 mg up to 500 mg); once a day or twice a day for 1 day in up to 3 periods.
Arm Title
Placebo Part 1
Arm Type
Placebo Comparator
Arm Description
once a day or twice a day for 1 day in up to 3 periods.
Arm Title
LY2811376 - Part 2 low dose
Arm Type
Experimental
Arm Description
Single dose of LY2811376, dose determined by part 1
Arm Title
LY2811376 - Part 2 high dose
Arm Type
Experimental
Arm Description
Single dose of LY2811376, dose determined by part 1
Arm Title
Placebo Part 2
Arm Type
Placebo Comparator
Arm Description
single dose
Intervention Type
Drug
Intervention Name(s)
LY2811376
Intervention Description
Oral capsules
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral capsules
Primary Outcome Measure Information:
Title
Clinical Effects
Time Frame
Predose and up to Day 6 of each period
Secondary Outcome Measure Information:
Title
Plasma concentration of LY2811376 (Cmax)
Time Frame
Predose and up to Day 6 of each period
Title
Plasma concentration of LY2811376 (AUC)
Time Frame
Predose and up to Day 6 of each period
Title
Amyloid beta 1-40 plasma concentrations
Time Frame
Predose and up to Day 6 of each period
Title
Cerebrospinal fluid (CSF) concentration of LY2811376 (Cmax) (Part 2 only)
Time Frame
Predose and up to 36 hours
Title
Cerebrospinal fluid (CSF) concentration of LY2811376 (AUC) (Part 2 only)
Time Frame
Predose and up to 36 hours
Title
Amyloid beta 1-40 cerebrospinal fluid CSF concentrations (Part 2 only)
Time Frame
Predose and up to 36 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy men and nonchild-bearing potential women 20 years or older Body mass index between 18-32kg/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. Consume more than 5 cups of coffee per day.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Glendale
State/Province
California
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25404952
Citation
Portelius E, Dean RA, Andreasson U, Mattsson N, Westerlund A, Olsson M, Demattos RB, Racke MM, Zetterberg H, May PC, Blennow K. beta-site amyloid precursor protein-cleaving enzyme 1(BACE1) inhibitor treatment induces Abeta5-X peptides through alternative amyloid precursor protein cleavage. Alzheimers Res Ther. 2014 Nov 17;6(5-8):75. doi: 10.1186/s13195-014-0075-0. eCollection 2014.
Results Reference
derived

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A Safety Study of LY2811376 Single Doses in Healthy Subjects

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