A Study of LY3053102 in Healthy Participants

Healthy Volunteers Clinical Trial

Official title:

A Single-Dose, Dose-Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetics of LY3053102 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01736241
• Other study ID #: 14514
• Secondary ID: I6I-MC-LMRA
• Status: Completed
• Phase: Phase 1
• Start date: December 2012
• Est. completion date: July 2013

Study information

• Verified date: September 2017
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study was to evaluate the safety and tolerability of the study drug known as LY3053102 in healthy participants. The study also investigated how much of the study drug entered the blood stream and how long it took the body to dispose of the study drug. Information about any side effects that occurred was also collected. The study was expected to last approximately 8 weeks for each participant (up to 4 weeks from screening to the administration of study drug and an additional 4 weeks of follow up).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

• Normal blood pressure

• Female participants were not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause

• Had a body mass index (BMI) of 18.5 to 40.0 kilograms per square meter (kg/m^2), inclusive, at screening

Exclusion Criteria:

• Had known allergies to LY3053102 or related compounds

• Had a history of significant disease that may have affected the actions of drugs or may pose a risk when taking the study medication

• Had a history of developing allergies, asthma, severe drug allergies (symptoms including, but not limited to, itching, red rashes, sores on the skin, scaling and shedding of skin), allergies or reactions to more than one drug, or have had bad reactions to skin creams containing corticosteroids

• Heavy smokers (more than 10 cigarettes a day)

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• LY3053102

• Placebo

Locations

Country	Name	City	State
Singapore	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.	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With One or More Adverse Events (AEs) or Any Serious AEs	A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.	Baseline through Day 31
Secondary	Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3053102	AUC curve from time 0 to 168 hours postdose of LY3053102.	Time 0 to 168 hours after study drug administration on Day 1
Secondary	PK: Observed Maximum Drug Concentration (Cmax) of LY3053102	Cmax of LY3053102 from time 0 to 168 hours after study drug administration on Day 1.	Time 0 to 168 hours after study drug administration on Day 1
Secondary	Number of Participants Who Developed Anti-LY3053102 Antibodies	LY3053102 anti-drug antibodies (ADA) were assessed at baseline, 15 and 29 days. The number of participants with an initial postbaseline positive titer (defined as a >=2-fold increase in the ADA titer from baseline) anti-drug (LY3053102) ADA at each time point were summarized.	Baseline, up to Day 31