NCT01981928

A Clinical Trial to Investigate Safety and Tolerability of ASP7962 in Healthy Humans

A Phase 1, Randomized, Subject- and Investigator-blinded, Sponsor-unblinded, Placebo-controlled, Parallel Group Study to Assess the Safety, Tolerability and Pharmacokinetics of Single Ascending Oral Doses of ASP7962, Including a Food-effect Evaluation in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Astellas Pharma Europe B.V. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to see how safe the study drug is and how well it is tolerated after dosing. The study will also investigate how the study drug is taken up, metabolized (chemically broken down), distributed through the body and excreted. A further aim is to look at how this process is possibly altered by food by giving the study drug in the presence and absence of meals.

Conditions

• Safety
• Tolerability
• Pharmacokinetics of ASP7962

Interventions

Type	Name	Description
DRUG	ASP7962	Oral
DRUG	Placebo	Oral

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2013-11-13
• Last updated: 2014-07-11

Locations

1 site across 1 country: United Kingdom