Clinical Trial: A Study to Evaluate Safety and Tolerability of BMN 111 Administered to Healthy Adult Volunteers
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase 1, Two-Part, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of BMN 111 Administered to Healthy Adult Volunteers
Brief Summary: The purpose of this study is to measure how much of the study drug gets into the blood- stream and how long it takes the body to get rid of it when given as a single dose. Information about any side effects that may occur will also be collected.
Detailed Summary:
Sponsor: BioMarin Pharmaceutical
Current Primary Outcome:
- Safety based on vitals signs [ Time Frame: Daily throughout the study Assessed for approximately 8 days following each single dose in Part 1, and for approximately 24 days following each daily dose in Part 2 ]
- Safety based on adverse events [ Time Frame: Daily throughout the study Assessed for approximately 8 days following each single dose in Part 1, and for approximately 24 days following each daily dose in Part 2 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Pharmacokinetics [ Time Frame: Daily on dosing days Assessed during Part 1 for approximately 10 days and during Part 2 for approximately 24 days ]
- Safety based on cardiovascular effects [ Time Frame: Daily throughout the study Assessed for approximately 8 days following each single dose in Part 1, and for approximately 24 days following each daily dose in Part 2 ]
Original Secondary Outcome: Same as current
Information By: BioMarin Pharmaceutical
Dates:
Date Received: March 14, 2012
Date Started: February 2012
Date Completion:
Last Updated: June 7, 2012
Last Verified: June 2012
