Investigation of Rate+Extent of Excretion of Radioactivity in Urine+Faeces After Oral Administration of [14C]AZD1386

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Pain

Treatments: Drug: AZD1386

Study type: Interventional

Funder types: Industry

Identifiers

NCT00832169

EudractCT: 2008-006552-22

D5090C00015

Details and patient eligibility

About

The aim of this study is to get information about absorption, distribution, metabolism and excretion as well as the tolerability and safety of AZD1386 in healthy male volunteers.

Enrollment: 6 estimated patients

Sex: Male

Ages: 35 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body Mass Index of 18 - 30 and weight of 50 to 100 kilos.
• Healthy volunteer must have regular bowel movements (at least once daily)

Exclusion criteria

• History of psychiatric or somatic disease/condition, which may interfere with the objectives of the study as judged by the investigator.
• A family history of short QT syndrome or sudden cardiac death amongst first degree relatives.
• Any clinically important abnormalities in heart rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes.

Trial design

6 participants in 1 patient group

1

Experimental group

Treatment:

Drug: AZD1386