Effect of Ketoconazole on Biliary Excretion of AZD0837

AstraZeneca20 enrolled

Overview

This is an explorative study and the scientific question to be investigated is if the biliary excretion of AZD0837 and its metabolites AR-H069927XX and AR-H067637XX are affected by co-administration with ketoconazole

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

AZD0837DRUG

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

KetoconazoleDRUG

tablets, orally, once daily for 3 days

ketoconazoleDRUG

dissolved tablets, 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

Amount of AZD0837, AR-H069927XX, and AR-H067637XX in bile and biliary clearance of AZD0837, AR-H069927XX, and AR-H067637XX.

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.

Pharmacogenetics

Time frame: One sampling during the study.

Data from ClinicalTrials.gov

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