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

Eli Lilly and Company18 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy Volunteers

Interventions

PlaceboDRUG

Administered orally

LY3000328DRUG

Administered orally

Eligibility

Sex: ALLMin age: 35 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Are overtly healthy males or females, as determined by medical history and physical examination

Locations (1)

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, Singapore

Outcomes

Primary Outcomes

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

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

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

Pharmacokinetics: Maximum concentration (Cmax) of LY3000328

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

Change in Cathepsin S (CatS) activity

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

Data from ClinicalTrials.gov

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