Pharmacokinetic Interaction Study to Assess the Effect of ASP015K on Mycophenolate Mofetil in Healthy Volunteers
A Phase 1, Open Label, Single Sequence, Drug Interaction Study of the Pharmacokinetics of ASP015K and Mycophenolate Mofetil (MMF) After Separate and Concomitant Administration to Healthy Adult Volunteers
1 other identifier
interventional
24
1 country
1
Brief Summary
This study characterizes the pharmacokinetic effect of ASP015K on mycophenolate mofetil in healthy volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started May 2009
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 1, 2011
CompletedFirst Posted
Study publicly available on registry
June 3, 2011
CompletedJune 3, 2011
June 1, 2011
1 month
June 1, 2011
June 1, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment of pharmacokinetic variables through analysis of blood and urine samples
Up to 13 Days
Study Arms (1)
ASP015K and Mycophenolate Mofetil
EXPERIMENTALInterventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Pharmacology of Miami
Miami, Florida, 33014, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Pharma Global Development
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 1, 2011
First Posted
June 3, 2011
Study Start
May 1, 2009
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
June 3, 2011
Record last verified: 2011-06