NCT00812344

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Dec 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 22, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

December 3, 2010

Status Verified

December 1, 2010

Enrollment Period

3 months

First QC Date

December 19, 2008

Last Update Submit

December 2, 2010

Conditions

Healthy

Keywords

pharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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.

Study Arms (2)

1

EXPERIMENTAL
Drug: AZD0837

2

ACTIVE COMPARATOR

AZD0837 + Ketoconazole

Drug: AZD0837Drug: Ketoconazole

Interventions

AZD0837DRUG

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

12
ketoconazoleDRUG

tablets, orally, once daily for 3 days

2

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • body mass index (BMI) between 19 to 30 kg/m2 and body weight between 50 to 100 kg inclusive

You may not qualify if:

  • Significant illness, trauma or surgical procedures.
  • Clinically significant laboratory abnormalities.
  • Clinically significant medical history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Uppsala, Sweden

Location

MeSH Terms

Interventions

AZD 0837Ketoconazole

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Lars Knutson, MD, PhD

    Inst för Kirurgiska VetenskaperUppsala Universitet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 19, 2008

First Posted

December 22, 2008

Study Start

December 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

December 3, 2010

Record last verified: 2010-12

Locations

SE(1)