Pharmacokinetics of ASP1707 Clinical Trial
Official title:
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
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.
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.
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Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02106780 -
A Study to Evaluate the Effect of ASP1707 on the Bodies of Healthy Male Subjects After a Single Dose of Radioactive ASP1707
|
Phase 1 |