A Study of LY3009104 in Healthy Volunteers

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01536951
• Other study ID #: 14448
• Secondary ID: I4V-MC-JADO
• Status: Completed
• Phase: Phase 1
• First received: February 16, 2012
• Last updated: May 8, 2013
• Start date: February 2012
• Est. completion date: May 2013

Study information

• Verified date: May 2013
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• LY3009104
administered orally
• Placebo
Administered orally
• moxifloxacin
Administered orally

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	Incyte Corporation

Country where clinical trial is conducted

United States, 

Outcome

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