Status:
COMPLETED
A Study to Assess Drug Interaction of ASP015K and Midazolam
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Healthy
Pharmacokinetics of ASP015K and Midazolam
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The objective of the study is to characterize the effect of multiple doses of ASP015K on the pharmacokinetics of a single dose of midazolam.
Eligibility Criteria
Inclusion
- Subject weighing at least 45kg and BMI of 18-32 kg/m2, inclusive
- If female, subject is at least 2 years post menopausal or is surgically sterile per documentation provided by a third party medical professional and the subject is not pregnant as documented by a negative serum pregnancy test
- If male, subject agrees to sexual abstinence, is surgically sterile, or is using a medically acceptable method to prevent pregnancy during the study period
Exclusion
- History of any clinically significant disorder, disease or malignancy excluding non-melanoma skin cancer
- Recent history (within 6 months) of drug or alcohol abuse or positive urine screen for drugs of abuse/illegal drugs
- Treatment with prescription drugs or complementary and alternative medicines (CAM) within 14 days prior to study drug administration, or over the counter medication within 1 week prior to study drug administration
- A symptomatic, viral, bacterial or fungal infection within 1 week prior to clinic check-in
- Positive test for hepatitis C antibody, or positive test for hepatitis B surface antigen (HBsAg)
- History of the human immunodeficiency virus (HIV) antibody
- Positive tuberculosis (TB) skin test or Quantiferon Gold test
- Vaccinated within the last 30 days prior to study drug administration
- Received an experimental agent within 30 days or five half-lives, whichever is longer, prior to study drug administration
- Any significant blood loss, donated one unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to clinic admission
- Absolute neutrophil count (ANC) \<2500 cells/mm3
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01182077
Start Date
June 1 2010
End Date
July 1 2010
Last Update
August 16 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Miami, Florida, United States, 33014