DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Drug Interactions

Intervention: Prednisone (Drug); VX-509 (Drug); Methylprednisolone (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Vertex Pharmaceuticals Incorporated

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Vertex Pharmaceuticals Incorporated

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.

Clinical Details

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

Primary outcome:

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

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

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

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Male.

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

Locations and Contacts

Vertex Investigational Site, Lenexa, Kansas, United States
Additional Information

Starting date: June 2013
Last updated: August 13, 2013

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017