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

Drug Interactions Clinical Trial

Official title:

An Open-Label, Phase 1 Study to Examine the Pharmacokinetic Interactions Between VX-509 and Prednisone or Methylprednisolone in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01886209
• Other study ID #: VX13-509-010
• Status: Completed
• Phase: Phase 1
• First received: June 20, 2013
• Last updated: August 13, 2013
• Start date: June 2013
• Est. completion date: August 2013

Study information

• Verified date: August 2013
• Source: Vertex Pharmaceuticals Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Drug Interactions

Intervention

Drug:
• Prednisone

• VX-509

• Methylprednisolone

Locations

Country	Name	City	State
United States	Vertex Investigational Site	Lenexa	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Vertex Pharmaceuticals Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK parameters including Cmax, area under the concentration-time curve from the time of dosing extrapolated to infinity (AUC0 8), 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	No
Primary	PK parameters including Cmax, area under the concentration-time curve from the time of dosing extrapolated to infinity (AUC0 8), and AUC0-last for methylprednisolone with or without VX-509		Multiple blood samples will be obtained over the 10 day open-label treatment phase	No
Secondary	Treatment-emergent adverse events, results of clinical laboratory tests, vital signs, and 12-lead electrocardiograms		Up to 18 days	No