A Study to Evaluate the Drug Interaction of ASP015K and Tacrolimus
This study has been completed.
Sponsor:
Astellas Pharma Inc
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01190670
First received: August 11, 2010
Last updated: October 12, 2010
Last verified: October 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy Pharmacokinetics of ASP015K and Tacrolimus |
Drug: Tacrolimus Drug: ASP015K |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label |
| Official Title: | A Phase 1, Open Label, Drug Interaction Study of the Pharmacokinetics of ASP015K and Tacrolimus After Separate and Concomitant Administration to Healthy Adult Subjects |
Resource links provided by NLM:
MedlinePlus related topics:
Drug Reactions
Drug Information available for:
Tacrolimus
U.S. FDA Resources
Further study details as provided by Astellas Pharma Inc:
Primary Outcome Measures:
- Pharmacokinetic variables assessment through analysis of blood and urine samples [ Time Frame: Days 1-13 and Days 26-33 (Part 1 only) sampled daily ] [ Designated as safety issue: No ]
| Enrollment: | 40 |
| Study Start Date: | July 2010 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Part 1, Group 1
ASP015K, low dose followed by high dose, with oral tacrolimus
|
Drug: Tacrolimus
Oral and Intravenous
Other Names:
Drug: ASP015K
Oral
|
|
Experimental: Part 1, Group 2
ASP015K, high dose followed by low dose, with oral tacrolimus
|
Drug: Tacrolimus
Oral and Intravenous
Other Names:
Drug: ASP015K
Oral
|
|
Experimental: Part 2
ASP015K high dose with intravenous tacrolimus
|
Drug: Tacrolimus
Oral and Intravenous
Other Names:
Drug: ASP015K
Oral
|
Detailed Description:
This is a 2-part study. Part 1 is a 2-sequence, drug interaction study to determine the effect of two different ASP015K doses on the pharmacokinetics of oral tacrolimus. Part 2 is a 1-sequence drug interaction study to determine the effect of the higher dose ASP015K on the pharmacokinetics of IV tacrolimus.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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
- 12-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
Exclusion Criteria:
- 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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Sr Manager Clinical Trials Registry, Astellas Pharma Global Development |
| ClinicalTrials.gov Identifier: | NCT01190670 History of Changes |
| Other Study ID Numbers: | 015K-CL-PK16 |
| Study First Received: | August 11, 2010 |
| Last Updated: | October 12, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Astellas Pharma Inc:
|
ASP015K tacrolimus healthy volunteers |
Additional relevant MeSH terms:
|
Tacrolimus Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013