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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Brief Summary

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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

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Detailed Description

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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

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Blinding Strategy

DOUBLE

Interventions

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VX-509

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes