A Phase 1 interventional study of Tacrolimus and ASP015K in Healthy and Pharmacokinetics of ASP015K and Tacrolimus, sponsored by Astellas Pharma Inc. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-10-14.
Sponsored by Astellas Pharma Inc · Phase 1 and Interventional
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.
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.
Astellas Pharma Inc is the lead sponsor of 525 studies on the registry; 4 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 19 (68%) have results posted.
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Exclusion Criteria:
ASP015K, low dose followed by high dose, with oral tacrolimus
Drug: Tacrolimus · Drug: ASP015K
ASP015K, high dose followed by low dose, with oral tacrolimus
Drug: Tacrolimus · Drug: ASP015K
ASP015K high dose with intravenous tacrolimus
Drug: Tacrolimus · Drug: ASP015K
Oral and Intravenous
Also known as: FK506, Prograf
Oral
Pharmacokinetic variables assessment through analysis of blood and urine samples
Time frame: Days 1-13 and Days 26-33 (Part 1 only) sampled daily
The record gives a start of Jul 2010, a primary completion of Sep 2010 and a completion of Sep 2010. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Tacrolimus · Peficitinib