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NCT Number: NCT00838084

A Safety Study of LY2811376 Single Doses in Healthy Subjects

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.

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LY2811376

Drug

Oral capsules

Placebo

Drug

Oral capsules

Primary outcomes

  1. Clinical Effects

    Time frame: Predose and up to Day 6 of each period

Secondary outcomes

  1. Plasma concentration of LY2811376 (Cmax)

    Time frame: Predose and up to Day 6 of each period

  2. Plasma concentration of LY2811376 (AUC)

    Time frame: Predose and up to Day 6 of each period

  3. Amyloid beta 1-40 plasma concentrations

    Time frame: Predose and up to Day 6 of each period

  4. Cerebrospinal fluid (CSF) concentration of LY2811376 (Cmax) (Part 2 only)

    Time frame: Predose and up to 36 hours

  5. Cerebrospinal fluid (CSF) concentration of LY2811376 (AUC) (Part 2 only)

    Time frame: Predose and up to 36 hours

  6. Amyloid beta 1-40 cerebrospinal fluid CSF concentrations (Part 2 only)

    Time frame: Predose and up to 36 hours

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 6, 2009
Registry last updated
Jul 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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