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

Astellas

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: ASP1707; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02146742

2010-024040-15 (EudraCT Number)

1707-CL-0002

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 24 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Exclusion criteria

• Subjects with out-of-range T levels in serum at screening
• Subjects with any history of cancer

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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24 participants in 3 patient groups

1. ASP1707 lowest dose

Experimental group

Treatment:

Drug: Placebo

Drug: ASP1707

2 ASP1707 higher dose

Experimental group

Treatment:

Drug: Placebo

Drug: ASP1707

3. ASP1707 Highest dose

Experimental group

Treatment:

Drug: Placebo

Drug: ASP1707