NCT00789126

Single and Multiple Dose Escalation Study of VX-509 in Healthy Subjects

A Phase 1, Randomized, Double-Blind, Single-Dose Escalation Study and Multiple-Dose Escalation Study of VX-509 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Vertex Pharmaceuticals Incorporated · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Study to evaluate the safety and tolerability of single ascending doses and multiple ascending doses of VX-509 administered to healthy male and female subjects

Detailed description

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	VX-509

Timeline

• Start date: 2008-10-01
• First posted: 2008-11-11
• Last updated: 2009-02-19

Locations

1 site across 1 country: United States