NCT01182077CompletedPhase 1
A Phase 1, Open Label, Crossover, Drug Interaction Study of the Pharmacokinetics of ASP015K and Midazolam After Separate and Concomitant Administration to Healthy Adult Subjects
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Astellas Pharma Inc
- Enrollment
- 30
- Primary Endpoint
- Pharmacokinetic variables assessed through the analysis of blood and urine samples
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
Group 1
Experimental
ASP015K low dose and midazolam followed by ASP015K high dose and midazolam
Intervention: ASP015K (Drug)
Group 1
Experimental
ASP015K low dose and midazolam followed by ASP015K high dose and midazolam
Intervention: Midazolam (Drug)
Group 2
Experimental
ASP015K high dose and midazolam followed by ASP015K low dose and midazolam
Intervention: ASP015K (Drug)
Group 2
Experimental
ASP015K high dose and midazolam followed by ASP015K low dose and midazolam
Intervention: Midazolam (Drug)
Outcomes
Primary Outcomes
Pharmacokinetic variables assessed through the analysis of blood and urine samples
Time Frame: Days 1-8 and Days 21-27
Secondary Outcomes
No secondary outcomes reported
Investigators
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