A Safety Study of LY2811376 Single Doses in Healthy Subjects

Single-Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of LY2811376 in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00838084

Enrollment

Registered

2009-02-06

Start date

2008-12-31

Completion date

2009-06-30

Last updated

2009-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

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.

Interventions

DRUGLY2811376

Oral capsules

DRUGPlacebo

Oral capsules

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Clinical Effects	Predose and up to Day 6 of each period

Secondary

Measure	Time frame
Plasma concentration of LY2811376 (AUC)	Predose and up to Day 6 of each period
Amyloid beta 1-40 plasma concentrations	Predose and up to Day 6 of each period
Plasma concentration of LY2811376 (Cmax)	Predose and up to Day 6 of each period
Cerebrospinal fluid (CSF) concentration of LY2811376 (AUC) (Part 2 only)	Predose and up to 36 hours
Amyloid beta 1-40 cerebrospinal fluid CSF concentrations (Part 2 only)	Predose and up to 36 hours
Cerebrospinal fluid (CSF) concentration of LY2811376 (Cmax) (Part 2 only)	Predose and up to 36 hours

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026