To Study the Absorption, Distribution, Metabolism and Excretion of AZD1305

A Phase I, Open, Randomised, Single-Centre, Crossover Study to Assess the Absorption, Distribution, Metabolism and Excretion (ADME) After Oral and Intravenous Administration of 14C-labelled and Non-labelled AZD1305 to Healthy Male Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00689247

Enrollment

Registered

2008-06-03

Start date

2008-04-30

Completion date

2008-05-31

Last updated

2010-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

AZD1305, ADME, pharmacokinetic, Absorption, distribution, metabolism, excretion

Brief summary

The purpose of this study is to learn more about how AZD1305 is handled by the body, i.e the absorption, distribution, metabolism and excretion of AZD1305.

Interventions

DRUGAZD1305

oral solution, single dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

35 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy volunteers * A body mass index (BMI=weight/height2) of 19 to 30 kg/m2

Exclusion criteria

* Potassium outside normal reference values * ECG findings outside normal range

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic variables	During all dosing visits

Secondary

Measure	Time frame
Adverse events, vital signs, ECG, laboratory variables and physical examination	During the study

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026