Clinical Trial: A Phase 1, Single- and Multi-Dose, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered ALN-TTRSC (Revusiran) in Healthy Volunteers

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single- and Multi-Dose, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Ad

Brief Summary: The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of ALN-TTRSC (revusiran) in healthy volunteer 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 63 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pharmacokinetics (PK) of ALN-TTRSC (revusiran) (Cmax, tmax, t1/2, AUC0-last, CL). [ Time Frame: Up to 90 days ]
  • Effect of ALN-TTRSC (revusiran) on transthyretin (TTR) (Determination of % Lowering of TTR to pretreatment/Baseline Levels). [ Time Frame: Up to 90 days ]
  • Effect of ALN-TTRSC (revusiran) on vitamin A (Determination of % Lowering of vitamin A to pretreatment/Baseline Levels). [ Time Frame: Up to 90 days ]
  • Effect of ALN-TTRSC (revusiran) on retinol binding protein (RBP) (Determination of % Lowering of RBP to pretreatment/Baseline Levels). [ Time Frame: Up to 90 days ]


Original Secondary Outcome:

  • Pharmacokinetics (PK) of ALN-TTRSC (Cmax, tmax, t1/2, AUC0-last, CL). [ Time Frame: Up to 90 days ]
  • Effect of ALN-TTRSC on transthyretin (TTR), vitamin A, and retinol binding protein (RBP) (Determination of % Lowering of TTR, vitamin A and RBP to pretreatment/Baseline Levels). [ Time Frame: Up to 90 days ]


Information By: Alnylam Pharmaceuticals

Dates:
Date Received: March 18, 2013
Date Started: March 2013
Date Completion:
Last Updated: February 4, 2016
Last Verified: February 2016