CompletedNCT00789126Updated Feb 19, 2009

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

A Phase 1 interventional study of VX-509 in Healthy, sponsored by Vertex Pharmaceuticals Incorporated. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-02-19.

Sponsored by Vertex Pharmaceuticals Incorporated · Phase 1 and Interventional

Phase: Phase 1
Study type: Interventional
Enrollment: 72
Allocation: Randomized
Ages: 18 Years to 60 Years
Sex: All

Study 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

Read the 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.

Conditions studied

Healthy

In context

Lead sponsor

Vertex Pharmaceuticals Incorporated is the lead sponsor of 243 studies on the registry; 19 are open to participants now.

Of its 102 completed or terminated interventional studies of FDA-regulated products, 49 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 60 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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 design

Phase: Phase 1
Allocation: Randomized
Masking: Double
Enrollment: 72 participants (estimated)

Interventions

DrugVX-509

What researchers measure

Primary outcomes

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 outcomes

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

Study locations

1 site

Lenexa, Kansas, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 19, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00789126
Lead sponsor: Vertex Pharmaceuticals Incorporated
First posted: Nov 11, 2008
Start date: Oct 2008
Last update: Feb 19, 2009

Study contacts

George Spencer-Green, MD, MS

study director · Vertex Pharmaceuticals Incorporated

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.

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Discussion

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