Single and Multiple Dose Escalation Study of VX-509 in Healthy Subjects
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
|Official Title:||A Phase 1, Randomized, Double-Blind, Single-Dose Escalation Study and Multiple-Dose Escalation Study of VX-509 in Healthy Subjects|
- Safety and Tolerability as measured by adverse events (AEs) and clinically relevant changes in laboratory values, vital signs, electrocardiograms (ECGs), and physical examination variables [ Time Frame: Specified timepoints in the protocol ] [ Designated as safety issue: Yes ]
- Pharmacokinetics (PK) parameters (Cmax, AUC, t1/2, tmax) [ Time Frame: Specified timepoints in the protocol ] [ Designated as safety issue: No ]
- Pharmacodynamics (PD)parameters of percent and actual change from baseline for a panel of JAK-dependent biomarkers [ Time Frame: Specified timepoints in the protocol ] [ Designated as safety issue: No ]
|Study Start Date:||October 2008|
Part A of the study will evaluate the safety and tolerability, PK, and PD of single ascending doses of VX-509.
Part B will evaluate the safety and tolerability, PK, and PD of multiple ascending doses of VX-509 administered for 14 days.
A total of 72 subjects will be enrolled: 36 subjects in Part A and 36 subjects in Part B.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00789126
|United States, Kansas|
|Lenexa, Kansas, United States|
|Study Director:||George Spencer-Green, MD, MS||Vertex Pharmaceuticals Incorporated|