Status:
COMPLETED
Single and Multiple Dose Escalation Study of VX-509 in Healthy Subjects
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Conditions:
Healthy
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- Healthy, non-smoking male or healthy, non-smoking, non-pregnant female
- Able to comply with study procedures
- Male subjects must agree to use 2 highly effective methods of contraception
- Female subjects must be of documented non-child-bearing potential or must agree to use 2 highly effective methods of contraception
- No clinically significant abnormal results for physical examination or clinically significant out of range laboratory results
Exclusion
- History of any significant illness
- Illness within 5 days before Day 1
- Regular treatment with any medications
- Any type of tobacco or nicotine use
- History of drug or alcohol abuse or addiction within 2 years before Screening visit
- Positive tuberculin skin test at Screening
- Female subjects who are lactating or planning to become pregnant during the study period or within 90 days of last dose of study drug
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00789126
Start Date
October 1 2008
Last Update
February 19 2009
Active Locations (1)
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1
Lenexa, Kansas, United States