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Completed

NCT Number: NCT01227252

A Safety Study of LY2886721 Multiple Doses in Healthy Subjects

This is a Phase 1 study in healthy subjects to evaluate the safety and tolerability of LY2886721 multiple doses, how the body handles the drug, and the drug's effect on the body.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

20 year and older

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, 91206, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy men and non-childbearing potential women
  • Body mass index between 18.0-32.0 kilograms per square meter (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 (for example, coffee, tea) per day

Treatment and study plan

LY2886721

Drug

5 milligrams (mg) up to 35 mg, administered orally as capsules, daily for 14 days

Placebo

Drug

Administered orally as capsules, daily for 14 days

Primary outcomes

  1. Number of Participants With Clinically Significant Effects

    Time frame: Predose up to Day 70

    Clinically significant effects were defined as serious and nonserious adverse events. A summary of serious and all other nonserious adverse events is located in the Reported Adverse Event module. The number of participants with at least 1 adverse event in each treatment arm is reported for this outcome measure.

Secondary outcomes

  1. Plasma Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY2886721

    Time frame: Predose (Day 14) up to Day 19

  2. Plasma Area Under the Concentration Versus Time Curve (AUC) of LY2886721

    Time frame: Predose (Day 14) to 24 Hours post-dose (Day 15)

    Area under the concentration versus time curve during 1 dosing interval (1 dosing interval=24 hours) at steady state (AUCτ,ss) is being reported for this outcome measure.

  3. Plasma Amyloid Beta (Aβ) 1-40 Concentration

    Time frame: Predose (Day 14) up to Day 19

    The minimum concentration (Cnadir) is being reported for this outcome measure.

  4. Cerebrospinal Fluid (CSF) Concentration of LY2886721

    Time frame: 24 Hours post-dose (Day 15)

  5. Change From Baseline to Day 15 Endpoint in Cerebrospinal Fluid (CSF) Amyloid Beta (Aβ) 1-40 Concentration

    Time frame: Predose (Day 14), 24 Hours post-dose (Day 15)

    The Least Squares means were adjusted for baseline concentration.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Multiple-Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of LY2886721 in Healthy Subjects

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 25, 2010
Registry last updated
Jul 19, 2019

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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