NCT01958047

A Study to Assess the Effect of Race on How a Single Dose of ASP3652 is Taken up, Metabolized and Distributed Through the Bodies of Young, Healthy Male and Female Subjects, and Its Safety and Tolerability

A Phase 1 Open-label Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a Single Dose of ASP3652 in Caucasian, Japanese, Black/African and Chinese Healthy Male and Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Astellas Pharma Europe B.V. · Industry
• Sex: All
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study investigates how ASP3652 is taken up, broken down, and distributed through the body and excreted in individuals of different races. The study also investigates levels of biochemical markers in the bloodstream, and determines how safe the study drug is and how well it is tolerated after dosing. A further aim is to look at how the processes of metabolism, distribution and excretion of the study drug are possibly altered by the daily diet of the volunteers taking part.

Detailed description

This is an open label study to assess the pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of a single dose of ASP3652 in healthy male and female subjects from Caucasian, Japanese, Black/African and Chinese origin. A total of 64 healthy male and female subjects are included in this study (16 subjects per race group). Each race group comprises 8 female subjects and 8 male subjects. Screening assessments are performed from Day -22 to Day -2, and subjects are admitted to the clinic on Day -1, where they remain until Day 4. On Day 1, the subjects receive a single oral dose of ASP3652, and are discharged on Day 4 when all assessments have been performed and if there are no medical reasons to stay longer. An end of study visit (ESV) is performed 7-14 days after discharge. For each race group, plasma samples for PK and PD analysis are collected. Vital signs, safety electrocardiogram (ECG) measurements, safety laboratory assessments, physical examination, adverse events (AEs) and concomitant medications are monitored throughout study. In order to identify potential relationships between dietary intake and the PK of a single dose of ASP3652, all subjects record their diet for 3 days during the screening period in order to assess daily dietary intake (including total daily caloric intake; daily cholesterol intake; and total fat, saturated fat, carbohydrate and protein as a percentage of total calories).

Conditions

• Pharmacokinetics
• Pharmacodynamics
• Healthy Subjects
• Effect of Race

Interventions

Type	Name	Description
DRUG	ASP3652	Oral

Timeline

• Start date: 2012-07-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2013-10-08
• Last updated: 2013-10-08

Locations

1 site across 1 country: United Kingdom