A Study to Assess the Safety, Tolerability and Effects of Single and Multiple Ascending Doses of ASP1707 in Healthy Male and Pre-menopausal Female Subjects, Including a Comparison of the Effects Under Fasted and Fed Conditions in Healthy Young Male Subjects

Summary

This study consists of four parts:

Part 1 is a randomized, double-blind, placebo-controlled, single ascending dose study in healthy young male subjects to evaluate the safety, tolerability pharmacokinetics (PK) and effect on certain hormones and if possible to determine the highest well-tolerated dose of ASP1707 in healthy young male subjects under fasted conditions.

Part 2 is an open label, randomized crossover, single dose study to determine the effect of food on the pharmacokinetics of ASP1707and effect on certain hormones in healthy young male subjects.

Part 3 is a randomized, double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety, tolerability and pharmacokinetics (PK) of ASP1707 in healthy elderly men and healthy premenopausal females, and to determine the effect on certain hormones in males. Age and gender is also evaluated.

Part 4 is a randomized, double-blind, placebo-controlled, parallel, multiple dose study to evaluate the safety, tolerability and PK of ASP1707, and its effect on certain hormones in healthy pre-menopausal female subjects.

Conditions

• Pharmacokinetics of ASP1707
• Pharmacodynamics of ASP1707

Interventions

DRUG

ASP1707 single dose of dose levels 1 -7

Oral, dose escalation

DRUG

Placebo single dose of dose levels 1-7

Oral, dose escalation, healthy young male

DRUG

ASP1707 single dose fasted

Oral, healthy young male

DRUG

ASP1707 single dose fed

Oral, healthy young male

DRUG

ASP1707 multiple dose of dose levels 1-4

Oral, multiple dose escalation, healthy elderly male

DRUG

Placebo multiple dose of dose levels 1-4

Oral, multiple dose escalation, healthy elderly male

DRUG

ASP1707 multiple dose of dose levels 1-2

Oral, multiple dose escalation, healthy pre-menopausal female

DRUG

Placebo multiple dose of dose levels 1-2

Oral, multiple dose escalation, healthy pre-menopausal female

DRUG

ASP1707 parallel multiple dose of dose levels 1-3

Oral, multiple dose, healthy pre-menopausal female

DRUG

Placebo parallel multiple dose

Oral, dose escalation, healthy pre-menopausal female

Sponsors & Collaborators

• Astellas Pharma Europe B.V.

  lead INDUSTRY

Principal Investigators

• Clinical Study Manager · Astellas Pharma Europe B.V.

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-06-30

Primary Completion

2011-08-31

Completion

2011-08-31

Countries

• France

Study Locations