A Study to Assess the Effects of Single Ascending Doses of ASP1707 in Healthy Young Japanese Male Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2011-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Three groups of 8 Japanese males are given single ascending doses of ASP1707 or placebo to assess the safety and tolerability, and to evaluate how it is absorbed, metabolized and distributed through the body.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP7713 in Healthy Non-Japanese Adult and Elderly Subjects and Healthy Japanese Adult Subjects

NCT03108755

Healthy Volunteers

COMPLETED PHASE1

Study to Evaluate the Safety and Tolerability of ASP8062 in Healthy Japanese Male and Female Subjects

NCT03183739

Healthy Volunteers

COMPLETED PHASE1

Safety, Tolerability and Pharmacokinetic Study of ASP1517 in Healthy Non-elderly Male Volunteers

NCT00978198

Healthy Volunteers

COMPLETED PHASE1

Study to Evaluate the Safety and Pharmacokinetics of ASP2151 in Healthy Non-elderly and Elderly Subjects

NCT02796118

Healthy Subjects

COMPLETED PHASE1

A Study to Evaluate Safety of Multiple Dose of ASP0456 in Healthy Subjects

NCT01427387

Healthy Pharmacokinetics of ASP0456

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The first group receives the lowest dose while the last group receives the highest dose. ASP1707 or matching placebo is administered as a single dose under fasted conditions.

Screening takes place from Day -22 to Day -2. Subjects are admitted to the clinic on Day -1 and remain until Day 5. An end of study visit (ESV) takes place 7-14 days after discharge.

Escalation to the next higher dose takes place after review of the safety and tolerability data from the previous dose.

Safety assessments are performed throughout the study. Plasma and urine samples are collected for pharmacokinetics (PK) analysis. Serum samples are collected for pharmacodynamic (PD) analysis.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Subjects

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1. ASP1707 lowest dose

Group Type EXPERIMENTAL

ASP1707

Intervention Type DRUG

oral

Placebo

Intervention Type DRUG

oral

2 ASP1707 higher dose

Group Type EXPERIMENTAL

ASP1707

Intervention Type DRUG

oral

Placebo

Intervention Type DRUG

oral

3. ASP1707 Highest dose

Group Type EXPERIMENTAL

ASP1707

Intervention Type DRUG

oral

Placebo

Intervention Type DRUG

oral

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ASP1707

oral

Intervention Type DRUG

Placebo

oral

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Born in Japan
* Both parents are of Japanese descent
* Time residing outside Japan does not exceed 5 years
* Maintains Japanese life style including diet
* Male subject must be non-fertile, i.e. surgically sterilized or must practice an effective contraceptive method