Skip to main content
OpenTrials
Completed

NCT Number: NCT01515358

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Volunteers

Age range

35 year–70 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

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

Treatment and study plan

Placebo

Drug

Administered orally

LY3000328

Drug

Administered orally

Primary outcomes

  1. 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)

Secondary outcomes

  1. Pharmacokinetics: Area under the concentration-time curve (AUC) of LY3000328

    Time frame: Pre-dose up to Day 6 post-dose

  2. Pharmacokinetics: Maximum concentration (Cmax) of LY3000328

    Time frame: Pre-dose up to Day 6 post-dose

  3. Change in Cathepsin S (CatS) activity

    Time frame: Pre-dose, up to 48 hours post-dose

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 24, 2012
Registry last updated
May 31, 2012

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.