NCT02359032

A Combined Single and Multiple Ascending Dose Study of ASP6858 in Healthy Subjects

A Phase 1 Combined Single and Multiple Ascending Oral Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP6858 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Astellas Pharma Europe B.V. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is evaluate the safety and tolerability of single and multiple ascending oral doses of ASP6858. This study will also evaluate the pharmacokinetics (PK) of ASP6858 and its metabolites as well as the effect of food to the PK of ASP6858. The study will also evaluate the pharmacodynamics of ASP6858.

Detailed description

This study has 2 parts: Part 1 is a placebo-controlled, single ascending dose study where male only subjects will be residential for 5-8 days (Part 1 will also include an open-label, food effect section); and Part 2 is a placebo-controlled, randomized, 2-way crossover, multiple ascending dose study where male and female subjects will be residential for 14-17 days for each treatment period. There will be a washout period between the 2 periods in Part 2.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	ASP6858	Oral tablets
DRUG	Placebo	Oral tablets

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2015-02-09
• Last updated: 2016-06-21

Locations

1 site across 1 country: United Kingdom