Single and Multiple Dose Escalation Study of VX-509 in Healthy Subjects
|ClinicalTrials.gov Identifier: NCT00789126|
Recruitment Status : Completed
First Posted : November 11, 2008
Last Update Posted : February 19, 2009
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: VX-509||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|Official Title:||A Phase 1, Randomized, Double-Blind, Single-Dose Escalation Study and Multiple-Dose Escalation Study of VX-509 in Healthy Subjects|
|Study Start Date :||October 2008|
- 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 ]
- Pharmacokinetics (PK) parameters (Cmax, AUC, t1/2, tmax) [ Time Frame: Specified timepoints in the protocol ]
- Pharmacodynamics (PD)parameters of percent and actual change from baseline for a panel of JAK-dependent biomarkers [ Time Frame: Specified timepoints in the protocol ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00789126
|United States, Kansas|
|Lenexa, Kansas, United States|
|Study Director:||George Spencer-Green, MD, MS||Vertex Pharmaceuticals Incorporated|