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Completed

NCT Number: NCT00812344

Effect of Ketoconazole on Biliary Excretion of AZD0837

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

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Uppsala, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD0837

Drug

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

Ketoconazole

Drug

tablets, orally, once daily for 3 days

Primary outcomes

  1. 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

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

    Time frame: Frequent sampling during 24 hours.

  2. 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.

  3. Pharmacogenetics

    Time frame: One sampling during the study.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Dec 22, 2008
Registry last updated
Dec 3, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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