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

Completed · Phase 1

Conditions studied: Healthy

In brief

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

Key facts

Study ID

NCT00789126

Run by

Vertex Pharmaceuticals Incorporated

People needed

72

Starts

2008-10-01

Last updated by the study team

2009-02-19

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Lenexa, Kansas, United States

Full record on ClinicalTrials.gov

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