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

Sponsored by:	Vertex Pharmaceuticals Incorporated
Information provided by:	Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:	NCT00789126

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 I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Safety Study
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

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

Responsible Party:	Vertex Pharmaceuticals ( George Spencer-Green, MD, MS )
Study ID Numbers:	VX08-509-002
Study First Received:	November 7, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00789126
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 16, 2009