NCT01430065CompletedPhase 1
A Phase 1, Open Label, Single Sequence, Drug Interaction Study of the Pharmacokinetics of ASP015K and Tacrolimus After Separate and Concomitant Administration to Healthy Adult Volunteers
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Astellas Pharma Inc
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Pharmacokinetic assessment of AUC through the analysis of blood and urine samples
Study Overview
Brief Summary
This study characterizes the pharmacokinetic effects of ASP015K on Tacrolimus in healthy volunteers.
Detailed Description
The subjects will be confined to the unit for 13 days and have a brief follow-up visit to obtain hematology blood samples. Numerous blood and urine samples will be taken to determine the pharmacokinetics of the drugs.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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 observed upon physical examination or 12-lead electrocardiogram (ECG)
- •Subjects must weigh at least 45 kg and have a body mass index (BMI) of 18-32 kg/m2
Exclusion Criteria
- •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, 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
Arms & Interventions
Tacrolimus and ASP015K
Experimental
Intervention: Tacrolimus (Drug)
Tacrolimus and ASP015K
Experimental
Intervention: ASP015K (Drug)
Outcomes
Primary Outcomes
Pharmacokinetic assessment of AUC through the analysis of blood and urine samples
Time Frame: Up to Day 13
Secondary Outcomes
- Pharmacokinetic assessment of maximum concentration (Cmax) through the analysis of blood and urine samples(Up to Day 13)
Investigators
Study Sites (1)
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