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

NCT01886209 | Completed Phase 1

• 1 other identifier: VX13-509-010
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Drug Interactions

Outcome Measures

Primary Outcomes (2)

• PK parameters including Cmax, area under the concentration-time curve from the time of dosing extrapolated to infinity (AUC0 ∞), and AUC0-last for prednisone and its metabolite prednisolone with or without VX-509

  Multiple blood samples will be obtained over the 10 day open-label treatment phase

• PK parameters including Cmax, area under the concentration-time curve from the time of dosing extrapolated to infinity (AUC0 ∞), and AUC0-last for methylprednisolone with or without VX-509

  Multiple blood samples will be obtained over the 10 day open-label treatment phase

Secondary Outcomes (1)

• Treatment-emergent adverse events, results of clinical laboratory tests, vital signs, and 12-lead electrocardiograms

  Up to 18 days

Study Arms (2)

Cohort 1

EXPERIMENTAL

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

Drug: Prednisone; Drug: VX-509

Cohort 2

EXPERIMENTAL

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

Drug: VX-509; Drug: Methylprednisolone

Interventions

Prednisone DRUG

Cohort 1

VX-509 DRUG

Cohort 1; Cohort 2

Methylprednisolone DRUG

Cohort 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

Study Sites (1)

Vertex Investigational Site

Lenexa, Kansas, United States

Location

MeSH Terms

Interventions

Prednisone; 2-((2-(1H-pyrrolo(2,3-b)pyridin-3-yl)pyrimidin-4-yl)amino)-2-methyl-N-(2,2,2-trifluoroethyl)butanamide; Methylprednisolone

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Prednisolone; Pregnadienetriols

Study Officials

• Medical Monitor

  Vertex Pharmaceuticals Incorporated

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2013
• First Posted: June 25, 2013
• Study Start: June 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: August 14, 2013

Record last verified: 2013-08

Locations

US (1)