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

This study has been completed.
Sponsor:
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
  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
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, 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) ]

Secondary Outcome Measures:
  • 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 ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Are overtly healthy males or females, as determined by medical history and physical examination
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01515358     History of Changes
Other Study ID Numbers: 14340
I5U-MC-ANBB ( Other Identifier: Eli Lilly and Company )
Study First Received: January 18, 2012
Last Updated: May 30, 2012

ClinicalTrials.gov processed this record on May 25, 2017