Clinical trial NCT01886209: Phase 1 PK Interaction Study Between VX-509 and Prednisone or Methylprednisolone in Healthy Male Subjects
Official title: An Open-Label, Phase 1 Study to Examine the Pharmacokinetic Interactions Between VX-509 and Prednisone or Methylprednisolone in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Drug Interactions
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2013-06-25
Enrollment: 28
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Multiple blood samples will be obtained over the 10 day open-label treatment phase
measure: 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
timeFrame: Multiple blood samples will be obtained over the 10 day open-label treatment phase
Secondary outcomes:
measure: Treatment-emergent adverse events, results of clinical laboratory tests, vital signs, and 12-lead electrocardiograms
timeFrame: Up to 18 days
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: Vertex Investigational Site
state: Kansas
Study officials:
affiliation: Vertex Pharmaceuticals Incorporated
name: Medical Monitor
role: STUDY_DIRECTOR
References: