A Study to Evaluate the Safety and Tolerability of LY3000328 in Healthy Participants
- Registration Number
- NCT01515358
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
- Are overtly healthy males or females, as determined by medical history and physical examination
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo 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. LY3000328 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.
- Primary Outcome Measures
Name Time Method Number of participants with one or more drug related adverse events (AEs) or any serious AEs Baseline to study completion (estimate 3 months)
- Secondary Outcome Measures
Name Time Method Pharmacokinetics: Area under the concentration-time curve (AUC) of LY3000328 Pre-dose up to Day 6 post-dose Pharmacokinetics: Maximum concentration (Cmax) of LY3000328 Pre-dose up to Day 6 post-dose Change in Cathepsin S (CatS) activity Pre-dose, up to 48 hours post-dose
Trial Locations
- 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