A Study to Evaluate the Safety and Tolerability of LY3000328 in Healthy Participants
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01515358
First received: January 18, 2012
Last updated: May 30, 2012
Last verified: May 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy Volunteers |
Drug: Placebo Drug: LY3000328 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Single-Dose, Dose-Escalation Study to Evaluate the Safety and Tolerability of LY3000328 in Healthy Subjects |
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- 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) ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Pharmacokinetics: Area under the concentration-time curve (AUC) of LY3000328 [ Time Frame: Pre-dose up to Day 6 post-dose ] [ Designated as safety issue: No ]
- Pharmacokinetics: Maximum concentration (Cmax) of LY3000328 [ Time Frame: Pre-dose up to Day 6 post-dose ] [ Designated as safety issue: No ]
- Change in Cathepsin S (CatS) activity [ Time Frame: Pre-dose, up to 48 hours post-dose ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 18 |
| Study Start Date: | February 2012 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 35 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Are overtly healthy males or females, as determined by medical history and physical examination
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01515358
Locations
| Singapore | |
| 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, 117597 | |
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri, 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
More Information
No publications provided
| Responsible Party: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT01515358 History of Changes |
| Other Study ID Numbers: | 14340, I5U-MC-ANBB |
| Study First Received: | January 18, 2012 |
| Last Updated: | May 30, 2012 |
| Health Authority: | Singapore: Health Sciences Authority |
ClinicalTrials.gov processed this record on June 18, 2013