NCT02368912

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

A Double Blind, Randomized, Placebo-controlled, Ascending Single and Multiple Oral Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP1707 in Healthy Young and Elderly Male Subjects and in Healthy Pre-menopausal Female Subjects Including an Open-label Comparison of Pharmacokinetics Under Fasted and Fed Conditions in Healthy Young Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 176 (actual)
• Sponsor: Astellas Pharma Europe B.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

Part 1 comprises 7 dose groups of 8 healthy young male subjects. ASP1707 or matching placebo ( 3 to 1 ratio) is given as a single dose under fasted conditions. The first group receives the lowest dose while the last group receives the highest dose. Part 2 (Food-Effect) The group consists of 12 healthy young male subjects who receive two separate doses of ASP1707 under fasted or fed conditions. Half of the subjects are dosed first under fasted condition and half of them had first an FDA high-fat breakfast. Subjects receive the alternate treatment on the second occasion. Dosing is separated by at least 7 days or 7 times t1/2 (terminal elimination half-life) as assessed from Part 1. Part 3 Comprises 4 dose groups of 12 healthy elderly men each, and two groups of 12 healthy premenopausal women. The latter are dosed ASP1707 or placebo in parallel to the 4 male groups. Subjects are fasted or fed depending on observations from Part 2. Dose levels are defined after evaluating interim safety, tolerability and PK and PD results from Part 1. A lower maximum dose is used in women than in men, based on preclinical data. Dose escalation in the men is independent from dose escalation in the women. Women and men receive once-daily dosing; Part 4 includes 4 groups, 1 placebo and 3 for ASP1707, each with 9 pre-menopausal women. Subjects in each dose group receive a fixed daily dose. Subjects are domiciled for various intervals during each of 3 menstrual cycles. Dosing occurs for 21 Days during the subjects' second menstrual cycle of the study (Day 1 of Period 2); fasted or fed depending on observations from Part 2.

Conditions

• Pharmacokinetics of ASP1707
• Pharmacodynamics of ASP1707

Interventions

Type	Name	Description
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

Timeline

• Start date: 2010-06-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2015-02-23
• Last updated: 2015-02-23

Locations

1 site across 1 country: France