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Completed

NCT Number: NCT01736241

A Study of LY3053102 in Healthy Participants

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).

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Key information

Conditions

Healthy Volunteers

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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, 117597

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

LY3053102

Drug

Placebo

Drug

Primary outcomes

  1. Number of Participants With One or More Adverse Events (AEs) or Any Serious AEs

    Time frame: Baseline through Day 31

    A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

Secondary outcomes

  1. Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3053102

    Time frame: Time 0 to 168 hours after study drug administration on Day 1

    AUC curve from time 0 to 168 hours postdose of LY3053102.

  2. PK: Observed Maximum Drug Concentration (Cmax) of LY3053102

    Time frame: Time 0 to 168 hours after study drug administration on Day 1

    Cmax of LY3053102 from time 0 to 168 hours after study drug administration on Day 1.

  3. Number of Participants Who Developed Anti-LY3053102 Antibodies

    Time frame: Baseline, up to Day 31

    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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 29, 2012
Registry last updated
Jul 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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