A Study to Assess Drug Interaction of ASP015K and Midazolam
Completed · Phase 1
Conditions studied: Healthy, Pharmacokinetics of ASP015K and Midazolam
In brief
The objective of the study is to characterize the effect of multiple doses of ASP015K on the pharmacokinetics of a single dose of midazolam.
Key facts
- Study ID
- NCT01182077
- Run by
- Astellas Pharma Inc
- People needed
- 30
- Starts
- 2010-06-01
- Expected to finish
- 2010-07-01
- Last updated by the study team
- 2010-08-16
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Study site — Miami, Florida, United States
Full record on ClinicalTrials.gov
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