Clinical Trial: A Study of the Safety, Tolerability and Pharmacokinetics of ALN-TTR02 in Japanese Healthy Volunteers
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose, Safety, Tolerability and Pharmacokinetics Study of ALN-TTR02 in Japanese Healthy Volunteers
Brief Summary: The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of patisiran (ALN-TTR02) in Japanese subjects
Detailed Summary:
Sponsor: Alnylam Pharmaceuticals
Current Primary Outcome: The proportion of subjects experiencing adverse events (AEs), serious adverse events (SAEs) and study drug discontinuation [ Time Frame: Up to 28 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Pharmacodynamics (PD) of ALN-TTR02 (serum concentrations of Transthyretin, Vitamin A, and Retinol Binding Protein) [ Time Frame: Up to 90 days ]
- Observed maximum concentration (Cmax) of ALN-TTR02 [ Time Frame: Up to 90 days ]
- Time of observed maximum concentration (tmax) of ALN-TTR02 [ Time Frame: Up to 90 days ]
- Area under the plasma concentration versus time curve (AUC) of ALN-TTR02 [ Time Frame: Up to 90 days ]
- Terminal elimination half-life (t1/2) of ALN-TTR02 [ Time Frame: Up to 90 days ]
- Systemic clearance (CL) of ALN-TTR02 [ Time Frame: Up to 90 days ]
- Volume of distribution (V) of ALN-TTR02 [ Time Frame: Up to 90 days ]
- Renal clearance (CLR) of ALN-TTR02 [ Time Frame: Up to 90 days ]
Original Secondary Outcome: Same as current
Information By: Alnylam Pharmaceuticals
Dates:
Date Received: January 24, 2014
Date Started: January 2014
Date Completion:
Last Updated: May 22, 2015
Last Verified: May 2015
