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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00789126
First Posted: November 11, 2008
Last Update Posted: February 19, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Vertex Pharmaceuticals Incorporated
  Purpose
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
Healthy Drug: VX-509 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
Information from the National Library of Medicine

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


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

Responsible Party: George Spencer-Green, MD, MS, Vertex Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00789126     History of Changes
Other Study ID Numbers: VX08-509-002
First Submitted: November 7, 2008
First Posted: November 11, 2008
Last Update Posted: February 19, 2009
Last Verified: February 2009