Excretion of Radiolabelled AZD0837

AstraZeneca8 enrolled

Overview

This is an explorative study and the scientific question to be investigated in this study is if AZD0837 and/or its metabolites AR-H069927XX and AR-H067637XX and other unknown metabolites are excreted into the bile.

Study Type

INTERVENTIONAL

Allocation

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

AZD0837DRUG

Oral solution, dosing through the Loc-I-Gut catheter, single dose

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * body mass index (BMI) between 19 to 30 kg/m2 and body weight between 50 to 100 kg inclusive Exclusion Criteria: * Significant illness, trauma or surgical procedures. * Clinically significant laboratory abnormalities. * Clinically significant medical history.

Locations (1)

Research Site

Uppsala, Sweden

Outcomes

Primary Outcomes

The amounts of total radioactivity excreted in bile. Metabolic profile of AZD0837 excreted in bile and identification of previously unknown metabolites and the amounts of AZD0837, AR-H069927XX and AR-H067637XX in bile.

Time frame: Frequent sampling through a Loc-I-Gut catheter for up to 3 hours post dose.

Secondary Outcomes

PK variables of AZD0837, AR-H069927XX, and AR-H067637XX.

Time frame: Frequent sampling during 24 hours.

Adverse events, physical examination, safety laboratory variables, blood pressure, pulse and electrocardiography.

Time frame: Some of the safety variables will be followed at each visit, some less frequent.

Data from ClinicalTrials.gov

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