A Study to Evaluate the Safety and Tolerability of LY3000328 in Healthy Participants

May 30, 2012 updated by: Eli Lilly and Company

A Single-Dose, Dose-Escalation Study to Evaluate the Safety and Tolerability of LY3000328 in Healthy Subjects

The purposes of this study are to determine the safety and side effects of LY3000328, to determine how well the body will tolerate LY3000328, and to determine how long LY3000328 remains in the body.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 117597
        • 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.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Are overtly healthy males or females, as determined by medical history and physical examination

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Single dose of placebo administered orally in 1 out of 3 study periods separated by at least a 7-day wash-out period between each dose.
Drug: Placebo
Administered orally
Experimental: LY3000328
Single escalating dose of up to 300 mg/kg of LY3000328 administered orally in 2 out of 3 study periods separated by at least a 7 day wash-out period between each dose.
Drug: LY3000328
Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with one or more drug related adverse events (AEs) or any serious AEs
Time Frame: Baseline to study completion (estimate 3 months)
Baseline to study completion (estimate 3 months)

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics: Area under the concentration-time curve (AUC) of LY3000328
Time Frame: Pre-dose up to Day 6 post-dose
Pre-dose up to Day 6 post-dose
Pharmacokinetics: Maximum concentration (Cmax) of LY3000328
Time Frame: Pre-dose up to Day 6 post-dose
Pre-dose up to Day 6 post-dose
Change in Cathepsin S (CatS) activity
Time Frame: Pre-dose, up to 48 hours post-dose
Pre-dose, up to 48 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

January 18, 2012

First Submitted That Met QC Criteria

January 18, 2012

First Posted (Estimate)

January 24, 2012

Study Record Updates

Last Update Posted (Estimate)

May 31, 2012

Last Update Submitted That Met QC Criteria

May 30, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • 14340
  • I5U-MC-ANBB (Other Identifier: Eli Lilly and Company)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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