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

A Phase 1, Randomized, Double-Blind, Single-Dose Escalation Study and Multiple-Dose Escalation Study of VX-509 in Healthy Subjects

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: VX-509

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.

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Lenexa, Kansas, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Vertex Pharmaceuticals Incorporated
• Investigators: Study Director: George Spencer-Green, MD, MS, Vertex Pharmaceuticals Incorporated

Study record dates

Study Major Dates

• Study Start: October 1, 2008

Study Registration Dates

• First Submitted: November 7, 2008
• First Submitted That Met QC Criteria: November 9, 2008
• First Posted (Estimate): November 11, 2008

Study Record Updates

• Last Update Posted (Estimate): February 19, 2009
• Last Update Submitted That Met QC Criteria: February 18, 2009
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Other Study ID Numbers: VX08-509-002