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

Phase 1

Completed

• Conditions: Pharmacokinetics of ASP015K; Drug Interactions; Healthy Subjects
• Interventions: Drug: ASP015K; Drug: Tacrolimus

• Registration Number: NCT01430065
• Lead Sponsor: Astellas Pharma Inc

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 Timeline

• Study Start: 2009-06
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Study First Submitted: 2011-06-30
• Status Verified: 2011-09
• Study First Submitted QC: 2011-09-06
• Last Update Submitted: 2011-09-06
• Study First Posted: 2011-09-07
• Last Update Posted: 2011-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tacrolimus and ASP015K	ASP015K	-
Tacrolimus and ASP015K	Tacrolimus	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic assessment of AUC through the analysis of blood and urine samples	Up to Day 13

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic assessment of maximum concentration (Cmax) through the analysis of blood and urine samples	Up to Day 13

Trial Locations

Locations (1)

Clinical Pharmacology of Miami; 🇺🇸 Miami, Florida, United States