Single and Multiple Dose Escalation Study of VX-509 in Healthy Subjects
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|