Pharmacokinetic Interaction Study to Assess the Effect of ASP015K on Mycophenolate Mofetil in Healthy Volunteers
Completed · Phase 1
Conditions studied: Healthy Subjects, Drug Interactions, Pharmacokinetics of ASP015K
In brief
This study characterizes the pharmacokinetic effect of ASP015K on mycophenolate mofetil in healthy volunteers.
Key facts
- Study ID
- NCT01364987
- Run by
- Astellas Pharma Inc
- People needed
- 24
- Starts
- 2009-05-01
- Expected to finish
- 2009-06-01
- Last updated by the study team
- 2011-06-03
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- If female, the 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, the subject agrees to sexual abstinence and/or to use a highly effective method of birth control during the study period
- Subject is medically healthy, with no clinically significant medical history or abnormalities
- Subjects must weigh at least 45 kg and have a body mass index (BMI) of 18-32 kg/m2
You may not qualify if…
- Subject has a history of chronic diarrhea
- Subject has been vaccinated within the last 60 days prior to study drug administration
- The subject has a previous history of any clinically significant neurological, gastro-intestinal, renal, hepatic, pulmonary, metabolic, cardiovascular, psychiatric, endocrine, and hematological disorder or disease
- Subject has a positive test for hepatitis C antibody, or positive for hepatitis B surface antigen (HBsAg)
- Subject has a history of the human immunodeficiency virus (HIV) antibody
- The subject has an absolute neutrophil count (ANC) < 2500 cells/mm3
- Subject has had clinically significant illness within 1 month prior to study drug administration
- Subject has a recent history (within the last 6 months) of drug or alcohol abuse or a positive urine screen for alcohol or drugs of abuse/illegal drugs
Where it is running
- Clinical Pharmacology of Miami — Miami, Florida, United States
Full record on ClinicalTrials.gov
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