Clinical trial NCT00838084: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2009-02-06
Enrollment: 61
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Clinical Effects
timeFrame: Predose and up to Day 6 of each period
Secondary outcomes:
measure: Plasma concentration of LY2811376 (Cmax)
timeFrame: Predose and up to Day 6 of each period
measure: Plasma concentration of LY2811376 (AUC)
timeFrame: Predose and up to Day 6 of each period
measure: Amyloid beta 1-40 plasma concentrations
timeFrame: Predose and up to Day 6 of each period
measure: Cerebrospinal fluid (CSF) concentration of LY2811376 (Cmax) (Part 2 only)
timeFrame: Predose and up to 36 hours
measure: Cerebrospinal fluid (CSF) concentration of LY2811376 (AUC) (Part 2 only)
timeFrame: Predose and up to 36 hours
measure: Amyloid beta 1-40 cerebrospinal fluid CSF concentrations (Part 2 only)
timeFrame: Predose and up to 36 hours
Other outcomes:
Locations:
city: Glendale
country: United States
facility: 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.
state: California
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
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.