A Study of LY3006072 in Healthy Participants
|ClinicalTrials.gov Identifier: NCT01640249|
Recruitment Status : Completed
First Posted : July 13, 2012
Last Update Posted : December 18, 2012
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|
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|
|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|
|Primary Completion Date :||November 2012|
|Study Completion Date :||November 2012|
Placebo Comparator: Placebo
Placebo capsules will match LY3006072
Capsules administered orally
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.
Capsules administered orally
- Number of participants with one or more drug related adverse events (AEs) or any serious AEs [ Time Frame: Up to 48 hours after dosing ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov 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|
|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|