Effect of Ketoconazole on Biliary Excretion of AZD0837

An Open, Randomised, Cross-over, Single Centre Pharmacokinetic (Phase I) Study of the Biliary Excretion Following Single Doses of AZD0837, Given in the Duodenum Via a Loc-I-Gut Catheter, Alone or in Combination With Ketoconazole (Once Daily for 4 Days), to Young Healthy Male Subjects

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: AZD0837; Drug: Ketoconazole; Drug: ketoconazole

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• Sweden
  • Uppsala, Sweden
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: AZD0837; Oral solution, dosing through the Loc-I-Gut catheter, single dose
Active Comparator: 2; AZD0837 + Ketoconazole	Drug: AZD0837; Oral solution, dosing through the Loc-I-Gut catheter, single dose; Drug: Ketoconazole; tablets, orally, once daily for 3 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Amount of AZD0837, AR-H069927XX, and AR-H067637XX in bile and biliary clearance of AZD0837, AR-H069927XX, and AR-H067637XX.	Frequent sampling through a Loc-I-Gut catheter for up to 3 hours post dose.

Secondary Outcome Measures

Outcome Measure	Time Frame
PK variables of AZD0837, AR-H069927XX, and AR-H067637XX.	Frequent sampling during 24 hours.
Adverse events, physical examination, safety laboratory variables, blood pressure, pulse and electrocardiography.	Some of the safety variables will be followed at each visit, some less frequent.
Pharmacogenetics	One sampling during the study.

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: December 19, 2008
• First Submitted That Met QC Criteria: December 19, 2008
• First Posted (Estimate): December 22, 2008

Study Record Updates

• Last Update Posted (Estimate): December 3, 2010
• Last Update Submitted That Met QC Criteria: December 2, 2010
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: pharmacokinetics
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Ketoconazole
• Other Study ID Numbers: D1250C00029