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

History of Changes

Tracking Information

First Received Date ^ICMJE

July 11, 2012

Last Updated Date

December 17, 2012

Start Date ^ICMJE

July 2012

Primary Completion Date

November 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01640249 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study of LY3006072 in Healthy Participants

Official Title ^ICMJE

A Single Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of LY3006072 in Healthy Subjects

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.

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 ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science

Condition ^ICMJE

Healthy Volunteers

Intervention ^ICMJE

Drug: Placebo
Capsules administered orally
Drug: LY3006072
Capsules administered orally

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

November 2012

Primary Completion Date

November 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01640249

Other Study ID Numbers ^ICMJE

14372, I6B-MC-HZBA

Has Data Monitoring Committee

Responsible Party

Eli Lilly and Company

Study Sponsor ^ICMJE

Eli Lilly and Company

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Eli Lilly and Company

Verification Date

December 2012

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

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