A Study of LY3006072 in Healthy Participants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01640249
First received: July 11, 2012
Last updated: December 17, 2012
Last verified: December 2012

July 11, 2012
December 17, 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01640249 on ClinicalTrials.gov Archive Site
  • Pharmacokinetics: Maximum concentration (Cmax) of LY3006072 [ Time Frame: Pre-dose through 96 hours after dosing ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Area under the concentration curve (AUC) of LY3006072 [ Time Frame: Pre-dose through 96 hours after dosing ] [ Designated as safety issue: No ]
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).

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01640249
14372, I6B-MC-HZBA
No
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