Status:
COMPLETED
Phase 1 PK Interaction Study Between VX-509 and Prednisone or Methylprednisolone in Healthy Male Subjects
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Conditions:
Drug Interactions
Eligibility:
MALE
18-55 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2013
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01886209
Start Date
June 1 2013
End Date
August 1 2013
Last Update
August 14 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Vertex Investigational Site
Lenexa, Kansas, United States