Effect of Ketoconazole on Biliary Excretion of AZD0837

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: ketoconazole; Drug: Ketoconazole; Drug: AZD0837

Study type: Interventional

Funder types: Industry

Identifiers

NCT00812344

D1250C00029

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

20 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: AZD0837

2

Active Comparator group

Description:

AZD0837 + Ketoconazole

Treatment:

Drug: AZD0837

Drug: Ketoconazole