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

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Placebo Drug: LY3006072 Phase 1

Detailed Description:

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).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Single Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of LY3006072 in Healthy Subjects
Study Start Date : July 2012
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo capsules will match LY3006072
Drug: Placebo
Capsules administered orally

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.
Drug: LY3006072
Capsules administered orally

Primary Outcome Measures :
  1. Number of participants with one or more drug related adverse events (AEs) or any serious AEs [ Time Frame: Up to 48 hours after dosing ]

Secondary Outcome Measures :
  1. Pharmacokinetics: Maximum concentration (Cmax) of LY3006072 [ Time Frame: Pre-dose through 96 hours after dosing ]
  2. Pharmacokinetics: Area under the concentration curve (AUC) of LY3006072 [ Time Frame: Pre-dose through 96 hours after dosing ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01640249

United States, Indiana
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.
Evansville, Indiana, United States, 47710
Sponsors and Collaborators
Eli Lilly and Company
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

Responsible Party: Eli Lilly and Company Identifier: NCT01640249     History of Changes
Other Study ID Numbers: 14372
I6B-MC-HZBA ( Other Identifier: Eli Lilly and Company )
First Posted: July 13, 2012    Key Record Dates
Last Update Posted: December 18, 2012
Last Verified: December 2012