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

This study has been completed.
Information provided by:
Vertex Pharmaceuticals Incorporated Identifier:
First received: November 7, 2008
Last updated: February 18, 2009
Last verified: February 2009
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

Condition Intervention Phase
Drug: VX-509
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Official Title: A Phase 1, Randomized, Double-Blind, Single-Dose Escalation Study and Multiple-Dose Escalation Study of VX-509 in Healthy Subjects

Further study details as provided by Vertex Pharmaceuticals Incorporated:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 72
Study Start Date: October 2008
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.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00789126

United States, Kansas
Lenexa, Kansas, United States
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
Study Director: George Spencer-Green, MD, MS Vertex Pharmaceuticals Incorporated
  More Information

Responsible Party: George Spencer-Green, MD, MS, Vertex Pharmaceuticals Identifier: NCT00789126     History of Changes
Other Study ID Numbers: VX08-509-002
Study First Received: November 7, 2008
Last Updated: February 18, 2009 processed this record on April 28, 2017