Pharmacokinetic Interaction Study to Assess the Effect of ASP015K on Mycophenolate Mofetil in Healthy Volunteers

• Sponsor: Astellas Pharma Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01364987
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arm: 1
• Duration (Months): 1
• Patients Per Site Per Month: 23.6

Study Details

Study Description

Brief Summary

This study characterizes the pharmacokinetic effect of ASP015K on mycophenolate mofetil in healthy volunteers.

Condition or Disease	Intervention/Treatment	Phase
Healthy Subjects; Drug Interactions; Pharmacokinetics of ASP015K	Drug: ASP015K; Drug: Mycophenolate Mofetil	Phase 1

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
• Actual Enrollment: 24 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Official Title: 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
• Study Start Date: May 1, 2009
• Actual Primary Completion Date: Jun 1, 2009
• Actual Study Completion Date: Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ASP015K and Mycophenolate Mofetil	Drug: ASP015K; oral; Drug: Mycophenolate Mofetil; oral; Other Names: CellCept

Outcome Measures

Primary Outcome Measures

1. Assessment of pharmacokinetic variables through analysis of blood and urine samples [Up to 13 Days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: 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

• 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, 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Pharmacology of Miami	Miami	Florida	United States	33014

Sponsors and Collaborators

• Astellas Pharma Inc

Investigators

• Study Director: Medical Director, Astellas Pharma Global Development

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01364987
• Other Study ID Numbers: 015K-CL-PK01
• First Posted: Jun 3, 2011
• Last Update Posted: Jun 3, 2011
• Last Verified: Jun 1, 2011

• Keywords provided by , ,: transplant; ASP015K; healthy subjects
• Additional relevant MeSH terms: Mycophenolic Acid; Peficitinib

Study Results

No Results Posted as of Jun 3, 2011