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Effect of Ketoconazole on Biliary Excretion of AZD0837

NCT ID: NCT00812344

Last Updated: 2010-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2009-03-31

Brief Summary

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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

Detailed Description

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Conditions

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Healthy

Keywords

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pharmacokinetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

AZD0837

Intervention Type DRUG

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

2

AZD0837 + Ketoconazole

Group Type ACTIVE_COMPARATOR

AZD0837

Intervention Type DRUG

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

Ketoconazole

Intervention Type DRUG

tablets, orally, once daily for 3 days

ketoconazole

Intervention Type DRUG

dissolved tablets, dosing through the Loc-I-Gut catheter, single dose

Interventions

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AZD0837

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

Intervention Type DRUG

Ketoconazole

tablets, orally, once daily for 3 days

Intervention Type DRUG

ketoconazole

dissolved tablets, dosing through the Loc-I-Gut catheter, single dose

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca R&D Mölndal

Principal Investigators

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Lars Knutson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Inst för Kirurgiska VetenskaperUppsala Universitet

Locations

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Research Site

Uppsala, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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D1250C00029

Identifier Type: -

Identifier Source: org_study_id