Completed

A Phase I, Double Blind, Placebo-controlled, Randomized 4-way Alternating Cross-over Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of Single Ascending Doses of ASP3652 in Healthy Young Caucasian Male and Female Subjects

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What is being tested

ASP3652

+ Placebo

+ ASP3652

Drug
Who is being recruted

From 18 to 55 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Phase 1
Interventional
Study Start: August 2012
See protocol details

Summary

Principal SponsorAstellas Pharma Europe B.V.
Last updated: March 21, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2012

Actual date on which the first participant was enrolled.

Each subject receives 3 single ascending doses of ASP3652 and a single dose of matching placebo during one randomly selected investigational period. Randomization is conducted separately for males and females. The washout period between dosing occasions is at least 7 days. Screening takes place from Day -22 to Day -2. Subjects are admitted to the clinic in the afternoon of Day -1 of investigational period 1, 2, 3 and 4 for pre-dose assessments. On Day -1 of all investigational periods, subjects do not take any food or drink for at least 10 hours before the anticipated dosing time on Day 1. For the duration of their stay in the clinic, subjects are not allowed to consume caffeine or other xanthine-containing drinks. The subjects are discharged on Day 4 of each investigational period. The End of Study Visit (ESV) is planned to take place 7-14 days after early discharge or after Day 4 of investigational period 4.

NCT01815684
Principal SponsorAstellas Pharma Europe B.V.
Last updated: March 21, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

26 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate
Body Mass Index more than or equal to 18.5 and less than 30.0kg/m2
Female subject must agree to practice an adequate contraceptive method with male sexual partners to prevent pregnancy
Male subject must agree to practice an adequate contraceptive method with female sexual partners to prevent pregnancy
Subject is white and of Caucasian origin
3 exclusion criteria prevent from participating
A mean QTc(F) interval of > 430 ms (for males) and > 450 ms (for females) after triplicate measurements, a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS). In case of an abnormal QTc(F) interval, the assessment may be repeated once (in triplicate). If the QTc(F) interval exceeds the limits, two additional Electrocardiogram (ECG)s can be recorded and the average of the three QTc(F) values should be used to determine the subject's eligibility
Known or suspected hypersensitivity to ASP3652, or any components of the formulation used
Pregnancy within 6 months before screening assessment or breast feeding within 3 months before screening (for females subjects only)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Dosed according to the following scheme: placebo, low dose, medium dose, high dose

Group II

Experimental
Dosed according to the following scheme: low dose, placebo, medium dose, high dose

Group III

Experimental
Dosed according to the following scheme: low dose, medium dose, placebo, high dose

Group IV

Experimental
Dosed according to the following scheme: low dose, medium dose, high dose, placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Centre for Human Drug Research

Leiden, NetherlandsOpen Centre for Human Drug Research in Google Maps
CompletedOne Study Center