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

Phase 1

Completed

• Conditions: Drug Interactions
• Interventions: Drug: Prednisone; Drug: VX-509; Drug: Methylprednisolone

• Registration Number: NCT01886209
• Lead Sponsor: Vertex Pharmaceuticals Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-20
• Study First Submitted QC: 2013-06-20
• Study First Posted: 2013-06-25
• Status Verified: 2013-08
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Last Update Submitted: 2013-08-13
• Last Update Posted: 2013-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1	VX-509	Prednisone 10 mg tablet on Day 1 and 7; VX-509 200 mg tablets on Days 2 thru 7
Cohort 2	Methylprednisolone	Methylprednisolone 8 mg tablet on Day 1 and 7; VX-509 200 mg tablets on Days 2 thru 7
Cohort 2	VX-509	Methylprednisolone 8 mg tablet on Day 1 and 7; VX-509 200 mg tablets on Days 2 thru 7
Cohort 1	Prednisone	Prednisone 10 mg tablet on Day 1 and 7; VX-509 200 mg tablets on Days 2 thru 7

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Treatment-emergent adverse events, results of clinical laboratory tests, vital signs, and 12-lead electrocardiograms	Up to 18 days

Trial Locations

Locations (1)

Vertex Investigational Site; 🇺🇸 Lenexa, Kansas, United States