A Study to Evaluate the Effect of ASP1707 on the Bodies of Healthy Male Subjects After a Single Dose of Radioactive ASP1707

Astellas

Status and phase

Completed

Phase 1

Conditions

Pharmacokinetics of ASP1707

Treatments

Drug: 14C-labeled ASP1707

Study type

Interventional

Funder types

Industry

Identifiers

NCT02106780

1707-CL-0021

2011-001701-27 (EudraCT Number)

Details and patient eligibility

About

Subjects receive a single oral dose of radioactive ASP1707 on Day 1. Blood, plasma, urine and feces samples are collected for analysis of 14C-radioactivity and ASP1707. Metabolites are collected until at least 144 hours after dosing.

Full description

Subjects are admitted to the clinic on Day -1 and receive a single oral dose of 14C-labeled ASP1707 on Day 1. They remain in the clinic for 6 days and are discharged on Day 7 if sufficient recovery of administered radioactivity is achieved, or the total excretion (urine + feces) per 24 hours is less than 1% of the administered dose during 2 consecutive 24-hour intervals. If these conditions are not met, the residential period may be prolonged for a maximum of 3 days. If after this time one of the conditions is still not met, subjects are requested to continue collecting their urine and/or feces at home for another 2 days. If after these additional 2 days one of the conditions is still not met, the condition of recovery of radioactivity is disregarded. Therefore only the total excretion condition is to be met by collecting 24-hour intervals for urine and feces once a week for up to 2 weeks. If the excretion condition is still not met after this time, no further samples are collected and the subject is discharged from the study.

Enrollment

6 patients

Sex

Male

Ages

35 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Subjects must be surgically sterilized and use condoms or must practice an effective contraceptive method to prevent pregnancies.
Body Mass Index more than or equal to 18.5 and less than 30.0 kg/m2.
Regular defecation pattern (minimum once per day).

Exclusion criteria

Any of the liver function tests above the upper limit of normal.
Exposure to radiation for diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton (excluding spinal column)), during work or during participation in a clinical study in the previous year.
Any use of drugs of abuse within 3 months prior to admission to the Clinical Unit.
History of smoking more than 10 cigarettes (or equivalent amount of tobacco) per day within 3 months prior to admission to the Clinical Unit.
Donation of blood or blood products within 3 months prior to admission to the Clinical Unit.
Positive serology test for Hepatitis B Surface Antigen (HBsAg), anti Hepatitis A Virus (HAV) Immunoglobulin M (IgM), anti Hepatitis C Virus (HCV) or anti Human Immunodeficiency Virus (HIV) 1+2.