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

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01430065
• Other study ID #: 015K-CL-PK02
• Status: Completed
• Phase: Phase 1
• First received: June 30, 2011
• Last updated: September 6, 2011
• Start date: June 2009
• Est. completion date: June 2009

Study information

• Verified date: September 2011
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study characterizes the pharmacokinetic effects of ASP015K on Tacrolimus in healthy volunteers.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Drug Interactions
• Healthy Subjects
• Pharmacokinetics of ASP015K

Intervention

Drug:
• ASP015K
oral
• Tacrolimus
oral

Locations

Country	Name	City	State
United States	Clinical Pharmacology of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic assessment of AUC through the analysis of blood and urine samples		Up to Day 13	No
Secondary	Pharmacokinetic assessment of maximum concentration (Cmax) through the analysis of blood and urine samples		Up to Day 13	No