NCT01515358
Completed
Phase 1
A Single-Dose, Dose-Escalation Study to Evaluate the Safety and Tolerability of LY3000328 in Healthy Subjects
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Number of participants with one or more drug related adverse events (AEs) or any serious AEs
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 35 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Are overtly healthy males or females, as determined by medical history and physical examination
Exclusion Criteria
- Not provided
Arms & Interventions
Placebo
Placebo Comparator
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.
Intervention: Placebo (Drug)
LY3000328
Experimental
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.
Intervention: LY3000328 (Drug)
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(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)
Investigators
Study Sites (1)
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