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

Phase 1

Completed

• Conditions: Healthy

• Registration Number: NCT00789126
• Lead Sponsor: Vertex Pharmaceuticals Incorporated

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

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 Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-11-07
• Study First Submitted QC: 2008-11-09
• Study First Posted: 2008-11-11
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-18
• Last Update Posted: 2009-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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