NCT00789126

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 7, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 11, 2008

Completed
Last Updated

February 19, 2009

Status Verified

February 1, 2009

First QC Date

November 7, 2008

Last Update Submit

February 18, 2009

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Safety and Tolerability as measured by adverse events (AEs) and clinically relevant changes in laboratory values, vital signs, electrocardiograms (ECGs), and physical examination variables

    Specified timepoints in the protocol

Secondary Outcomes (2)

  • Pharmacokinetics (PK) parameters (Cmax, AUC, t1/2, tmax)

    Specified timepoints in the protocol

  • Pharmacodynamics (PD)parameters of percent and actual change from baseline for a panel of JAK-dependent biomarkers

    Specified timepoints in the protocol

Interventions

VX-509DRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Lenexa, Kansas, United States

Location

MeSH Terms

Interventions

2-((2-(1H-pyrrolo(2,3-b)pyridin-3-yl)pyrimidin-4-yl)amino)-2-methyl-N-(2,2,2-trifluoroethyl)butanamide

Study Officials

  • George Spencer-Green, MD, MS

    Vertex Pharmaceuticals Incorporated

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 7, 2008

First Posted

November 11, 2008

Study Start

October 1, 2008

Last Updated

February 19, 2009

Record last verified: 2009-02

Locations

US(1)