A Study of LY3006072 in Healthy Participants

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01640249
• Other study ID #: 14372
• Secondary ID: I6B-MC-HZBA
• Status: Terminated
• Phase: Phase 1
• Start date: July 24, 2012
• Est. completion date: November 26, 2012

Study information

• Verified date: June 2019
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: November 26, 2012
• Est. primary completion date: November 26, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Placebo
Capsules administered orally
• LY3006072
Capsules 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.	Evansville	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

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	AEs that were considered possibly related to study drug, in the opinion of the investigator, were reported. A summary of serious and all other non-serious AEs, regardless of possible drug relatedness, is located in the Reported Adverse Event module.	Baseline, up to 21 days
Secondary	Pharmacokinetics: Maximum Concentration (Cmax) of LY3006072		Predose, 0.25, 0.5, 1, 2, 3, 5, 8, 12, 16, 24, 36, 48 and 96 hours postdose
Secondary	Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3006072	PK: Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC[0-inf] of LY3006072.	Predose, 0.25, 0.5, 1, 2, 3, 5, 8, 12, 16, 24, 36, 48 and 96 hours postdose