A Study of LY3009104 in Healthy Volunteers - Full Text View

Purpose

This will be a 2-part, randomized, subject- and investigator-blind study in healthy males and females.

Part A of this study is to determine a safe and tolerable single oral dose of LY3009104 that yields drug exposures slightly exceeding typical exposures anticipated from repeated administration of an efficacious dose to patients. The concentration of the drug in the blood stream will be measured and information about any side effects that may occur will also be collected.

Part B of this study is to evaluate the effect of LY3009104 on the electrical activity of the heart as measured by electrocardiogram (ECG) in relation to placebo following a single oral dose.

Condition	Intervention	Phase
Healthy Volunteers	Drug: LY3009104 Drug: Placebo Drug: moxifloxacin	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science
Official Title:	A Placebo-Controlled, Single Dose, Dose Escalation (Part A) and a Placebo- and Positive-Controlled Study of the Effect on the Electrocardiographic QT Interval of a Single Dose (Part B) of LY3009104 in Healthy Subjects

Resource links provided by NLM:

Drug Information available for: Moxifloxacin Moxifloxacin hydrochloride

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Number of participants with one or more drug related adverse events (AEs) or any serious AEs [ Time Frame: Up to 48 hours after administration of study drug ] [ Designated as safety issue: Yes ]
Part A. Pharmacokinetics: maximum concentration (Cmax) of LY3009104 [ Time Frame: Up to 48 hours after administration of study drug ] [ Designated as safety issue: No ]
Part A. Pharmacokinetics: area under the concentration curve (AUC) of LY3009104 [ Time Frame: Up to 48 hours after administration of study drug ] [ Designated as safety issue: No ]
Part B. Change from baseline through 24 hours post-dose in QTcF interval between LY3009104 and placebo [ Time Frame: Baseline, 24 hours post-dose ] [ Designated as safety issue: No ]

Estimated Enrollment:	69
Study Start Date:	February 2012
Study Completion Date:	May 2013
Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo Placebo tablets matching the LY3009104 tablets or capsules in size and appearance will be administered orally in 1 out of 3 study periods in Part A and Part B.	Drug: Placebo Administered orally
Experimental: LY3009104 Part A. Single escalating dose of up to 40 mg of LY3009104 administered orally in 2 out of 3 study periods separated by at least a 3 day wash-out period between each dose. Part B. Single dose of LY3009104 determined in Part A administered orally in 1 out of 3 study periods separated by at least a 3 day wash-out period between each period.	Drug: LY3009104 administered orally
Active Comparator: 400 mg moxifloxacin Part B. 400 mg moxifloxacin will be administered orally in 1 out of 3 study periods separated by at least a 3 day wash-out period between each period.	Drug: moxifloxacin Administered orally

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Are overtly healthy males or females as determined by medical history and physical examination. Are drug free, disease free, and no cardiac abnormalities.
Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator.
Have a clinically normal screening electrocardiogram (ECG) with a measurable QT interval as judged by the investigator, and which in Part B allows accurate measurements of QT interval.

Exclusion Criteria:

Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data.
Have an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risks associated with participating in the study or affects or confounds the QTc analysis or have QTc greater than 450 msec.
Regularly use known drugs of abuse and/or show positive findings on urinary drug screening.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01536951

Locations

United States, Florida
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.
Daytona Beach, Florida, United States, 32117

Sponsors and Collaborators

Eli Lilly and Company

Incyte Corporation

Investigators

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

More Information

No publications provided

Responsible Party:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT01536951 History of Changes
Other Study ID Numbers:	14448, I4V-MC-JADO
Study First Received:	February 16, 2012
Last Updated:	May 8, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Contraceptives, Oral, Combined

Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013