NCT00812643

Brief Summary

This is an explorative study and the scientific question to be investigated in this study is if AZD0837 and/or its metabolites AR-H069927XX and AR-H067637XX and other unknown metabolites are excreted into the bile.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_1 healthy

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

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
10 days until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

March 11, 2009

Status Verified

March 1, 2009

First QC Date

December 19, 2008

Last Update Submit

March 10, 2009

Conditions

Healthy

Keywords

pharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • The amounts of total radioactivity excreted in bile. Metabolic profile of AZD0837 excreted in bile and identification of previously unknown metabolites and the amounts of AZD0837, AR-H069927XX and AR-H067637XX in bile.

    Frequent sampling through a Loc-I-Gut catheter for up to 3 hours post dose.

Secondary Outcomes (2)

  • 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.

Interventions

AZD0837DRUG

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

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 0837

Study Officials

  • Lars Knutson, MD, PhD

    Inst för Kirurgiska VetenskaperUppsala Universitet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 19, 2008

First Posted

December 22, 2008

Study Start

January 1, 2009

Study Completion

February 1, 2009

Last Updated

March 11, 2009

Record last verified: 2009-03

Locations

SE(1)