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

NCT01430065 | Completed Phase 1

• 1 other identifier: 015K-CL-PK02
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pharmacokinetics of ASP015K; Drug Interactions; Healthy Subjects

Keywords

transplant; ASP015K; tacrolimus; Prograf; healthy volunteers

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic assessment of AUC through the analysis of blood and urine samples

  Up to Day 13

Secondary Outcomes (1)

• Pharmacokinetic assessment of maximum concentration (Cmax) through the analysis of blood and urine samples

  Up to Day 13

Study Arms (1)

Tacrolimus and ASP015K

EXPERIMENTAL

Drug: ASP015K; Drug: Tacrolimus

Interventions

ASP015K DRUG

oral

Tacrolimus and ASP015K

Tacrolimus DRUG

oral

Also known as: Prograf, FK506

Tacrolimus and ASP015K

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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 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

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, 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

Clinical Pharmacology of Miami

Miami, Florida, 33014, United States

Location

MeSH Terms

Interventions

peficitinib; Tacrolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Medical Director

  Astellas Pharma Global Development

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2011
• First Posted: September 7, 2011
• Study Start: June 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: September 7, 2011

Record last verified: 2011-09

Locations

US (1)