NCT01582399

Bioavailability of ASKP1240 in Healthy Subjects After Intravenous and Subcutaneous Administration of ASKP1240

A Phase 1 Single-Dose, Parallel Group, Randomized, Open-Label Study to Determine the Absolute Bioavailability of ASKP1240 After Intravenous and Subcutaneous Administration in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Astellas Pharma Global Development, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to assess levels of ASKP1240 in the blood after a single dose given intravenously (IV) or as a subcutaneous (SC) injection. The study will determine how the drug behaves inside the body and how it is eliminated from the body by looking at the pharmacokinetics of ASP1240. In addition, the study will determine the effects of ASKP1240 on the body by looking at its pharmacodynamics (PD) and at the safety and tolerability of ASKP1240 when given by IV or as SC injection.

Conditions

• Pharmacokinetics of ASKP1240
• Pharmacodynamics of ASKP1240
• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	ASKP1240	intravenous(IV) infusion and subcutaneous (SC)

Timeline

• Start date: 2012-02-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2012-04-20
• Last updated: 2012-12-10

Locations

1 site across 1 country: United States