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Phase 1 PK Interaction Study Between VX-509 and Prednisone or Methylprednisolone in Healthy Male Subjects

NCT ID: NCT01886209

Last Updated: 2013-08-14

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

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2013-08-31

Brief Summary

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This study is designed to evaluate the effect of VX-509 on the pharmacokinetics (PK) of corticosteroids (prednisone or methylprednisolone) and the effect of corticosteroids on the PK of VX-509 and its metabolite. The study will also evaluate the safety and tolerability of VX-509 when coadministered with each of these corticosteroids.

Detailed Description

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Conditions

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Drug Interactions

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1

Prednisone 10 mg tablet on Day 1 and 7; VX-509 200 mg tablets on Days 2 thru 7

Group Type EXPERIMENTAL

Prednisone

Intervention Type DRUG

VX-509

Intervention Type DRUG

Cohort 2

Methylprednisolone 8 mg tablet on Day 1 and 7; VX-509 200 mg tablets on Days 2 thru 7

Group Type EXPERIMENTAL

VX-509

Intervention Type DRUG

Methylprednisolone

Intervention Type DRUG

Interventions

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Prednisone

Intervention Type DRUG

VX-509

Intervention Type DRUG

Methylprednisolone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male subjects between 18 and 55 years of age, inclusive
* Body mass index (BMI) of 18.0 to 31.0 kg/m2, inclusive, and a total body weight \>50 kg

Exclusion Criteria

* History of any illness that, in the opinion of the investigator or the subject's general practitioner, might confound the results of the study or pose an additional risk in administering study drug(s) to the subject. This may include, but is not limited to, history of cardiovascular or central nervous system disease, diabetes, history or presence of clinically significant pathology, or history of mental disease
* Treatment with an investigational drug within 30 days or 5 half-lives preceding the first dose of study drug
* Subject has a female partner who is pregnant, nursing, or planning to become pregnant during the study or within 90 days of the last dose of study drug
* Positive test result for any of the following infectious disease tests at the Screening Visit: T-SPOT tuberculosis (TB) test, hepatitis B surface antigen, hepatitis C virus antibody, and human immunodeficiency virus 1 and 2 antibodies
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Vertex Pharmaceuticals Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Vertex Pharmaceuticals Incorporated

Locations

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Vertex Investigational Site

Lenexa, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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VX13-509-010

Identifier Type: -

Identifier Source: org_study_id