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

This study has been completed.
Sponsor:
Information provided by:
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT00789126
First received: November 7, 2008
Last updated: February 18, 2009
Last verified: February 2009
  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
Endpoint Classification: Safety Study
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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics (PK) parameters (Cmax, AUC, t1/2, tmax) [ Time Frame: Specified timepoints in the protocol ] [ Designated as safety issue: No ]
  • Pharmacodynamics (PD)parameters of percent and actual change from baseline for a panel of JAK-dependent biomarkers [ Time Frame: Specified timepoints in the protocol ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: George Spencer-Green, MD, MS, Vertex Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00789126     History of Changes
Other Study ID Numbers: VX08-509-002
Study First Received: November 7, 2008
Last Updated: February 18, 2009
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 30, 2014