A Study to Evaluate the Drug Interaction of ASP015K and Tacrolimus

NCT01190670 | Completed Phase 1

• 1 other identifier: 015K-CL-PK16
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to characterize the effect of multiple doses of ASP015K on the pharmacokinetics of a single oral dose or a single intravenous (IV) dose of tacrolimus.

Conditions

Healthy; Pharmacokinetics of ASP015K and Tacrolimus

Keywords

ASP015K; tacrolimus; healthy volunteers

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic variables assessment through analysis of blood and urine samples

  Days 1-13 and Days 26-33 (Part 1 only) sampled daily

Study Arms (3)

Part 1, Group 1

EXPERIMENTAL

ASP015K, low dose followed by high dose, with oral tacrolimus

Drug: Tacrolimus; Drug: ASP015K

Part 1, Group 2

EXPERIMENTAL

ASP015K, high dose followed by low dose, with oral tacrolimus

Drug: Tacrolimus; Drug: ASP015K

Part 2

EXPERIMENTAL

ASP015K high dose with intravenous tacrolimus

Drug: Tacrolimus; Drug: ASP015K

Interventions

Tacrolimus DRUG

Oral and Intravenous

Also known as: FK506, Prograf

Part 1, Group 1; Part 1, Group 2; Part 2

ASP015K DRUG

Oral

Part 1, Group 1; Part 1, Group 2; Part 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subject weighing at least 45kg and body mass index (BMI) of 18-32 kg/m2, inclusive
• If female, 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, subject agrees to sexual abstinence, is surgically sterile, or is using a medically acceptable method to prevent pregnancy during the study period
• lead ECG is normal or if abnormal, the abnormality is not clinically significant
• Clinical laboratory test results are within normal limits or not clinically significant
• Medically healthy, with no clinically significant medical history or abnormalities

You may not qualify if:

• History of any clinically significant disorder, disease or malignancy excluding non-melanoma skin cancer
• Recent history (within 6 months) of drug or alcohol abuse or positive urine screen for drugs of abuse/illegal drugs
• Treatment with prescription drugs or complementary and alternative medicines (CAM) within 14 days prior to study drug administration, or over the counter medication within 1 week prior to study drug administration
• A symptomatic, viral, bacterial or fungal infection within 1 week prior to clinic check-in
• Positive test for hepatitis C antibody, or positive test for hepatitis B surface antigen (HBsAg)
• History of human immunodeficiency virus (HIV) antibody
• Positive tuberculosis (TB) skin test or Quantiferon Gold test
• Vaccinated within the last 30 days prior to study drug administration
• Received an experimental agent within 30 days or five half-lives, whichever is longer, prior to study drug administration
• Any significant blood loss, donated one unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to clinic admission
• Absolute neutrophil count (ANC) \<2500 cells/mm3

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

Unknown Facility

Honolulu, Hawaii, 96813, United States

Location

MeSH Terms

Interventions

Tacrolimus; peficitinib

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Use Central Contact

  Astellas Pharma Global Development

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 11, 2010
• First Posted: August 30, 2010
• Study Start: July 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: October 14, 2010

Record last verified: 2010-10

Locations

US (1)