An Open, Single Dose, Phase I Study of the Excretion of Radioactivity, Metabolism and Pharmacokinetics Following Oral Administration of [14C]AZD1386 to Healthy Male Volunteers

AstraZeneca1 site in 1 country6 target enrollmentJanuary 2009

ConditionsPain

InterventionsAZD1386

DrugsAZD1386

Overview

Phase: Phase 1
Intervention: AZD1386
Conditions: Pain
Sponsor: AstraZeneca
Enrollment: 6
Locations: 1
Primary Endpoint: Excretion (rate+extent) of radioactivity in urine+faeces following oral administration of [14C]AZD1386
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

January 2009

End Date

February 2009

Last Updated

17 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

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.

Arms & Interventions

1

Intervention: AZD1386

Outcomes

Primary Outcomes

Excretion (rate+extent) of radioactivity in urine+faeces following oral administration of [14C]AZD1386

Time Frame: Until >90% of predicted total radioactivity has been recovered

Pharmacokinetics of total radioactivity in plasma + unchanged AZD1386 in plasma Metabolite profile in plasma+excreta

Time Frame: Predose, + postdose 0.5h, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h, 96h, 120h, 144hPredose + postdose 1h, 4h, 8h, 24h for excreta from predose (baseline) + postdose from 0h continously until 144h