A Study of LY3006072 in Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01640249
Recruitment Status : Completed
First Posted : July 13, 2012
Last Update Posted : December 18, 2012
Information provided by (Responsible Party):
Eli Lilly and Company

July 11, 2012
July 13, 2012
December 18, 2012
July 2012
November 2012   (Final data collection date for primary outcome measure)
Number of participants with one or more drug related adverse events (AEs) or any serious AEs [ Time Frame: Up to 48 hours after dosing ]
Same as current
Complete list of historical versions of study NCT01640249 on Archive Site
  • Pharmacokinetics: Maximum concentration (Cmax) of LY3006072 [ Time Frame: Pre-dose through 96 hours after dosing ]
  • Pharmacokinetics: Area under the concentration curve (AUC) of LY3006072 [ Time Frame: Pre-dose through 96 hours after dosing ]
Same as current
Not Provided
Not Provided
A Study of LY3006072 in Healthy Participants
A Single Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of LY3006072 in Healthy Subjects

The purpose of this study is to evaluate how safe LY3006072 (study drug) is and whether it causes any side effects. The study will also measure how much of the study drug gets into the blood stream and how long it takes the body to get rid of the study drug. The study drug will be given in the morning or evening with or without a meal.

This is the first time that this study drug is being given to humans. This study is for research purposes only and is not intended to treat any medical condition.

This study has two parts:

Part A - single ascending dose of LY3006072 administered to healthy participants in 3 of 4 study periods (placebo in 1 of 4 periods).

Part B - morning and evening doses of LY3006072 given to healthy participants in fed and fasted states in 2 or 3 of 3 study periods (placebo in 1 of 3 periods for some participants).

Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Healthy Volunteers
  • Drug: Placebo
    Capsules administered orally
  • Drug: LY3006072
    Capsules administered orally
  • Placebo Comparator: Placebo
    Placebo capsules will match LY3006072
    Intervention: Drug: Placebo
  • Experimental: LY3006072
    LY3006072 capsules starting at 1 milligram (mg) and escalating based on emerging data. Doses will be given orally once per period using capsule strengths of 0.5 mg, 5 mg, and 30 mg.
    Intervention: Drug: LY3006072
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
November 2012
November 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Overtly healthy males or females, as determined by medical history and physical examination
  • Male participants with a partner of childbearing potential must agree to use barrier protection during sexual intercourse while in the study and for 3 months after the last dose of study drug
  • Women must not be pregnant or nursing and must be of non-childbearing potential, due to either surgical sterilization or menopause
  • Body mass index between 19.0 and 30.0 kilograms per square meter (kg/m^2), inclusive
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
I6B-MC-HZBA ( Other Identifier: Eli Lilly and Company )
Not Provided
Not Provided
Eli Lilly and Company
Eli Lilly and Company
Not Provided
Study Director: 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) Eli Lilly and Company
Eli Lilly and Company
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP