HealthyPhase 1NCT00812344
Effect of Ketoconazole on Biliary Excretion of AZD0837
A Phase 1 study testing AZD0837 and Ketoconazole in people with Healthy, run by AstraZeneca at 1 site in Sweden.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- AZD0837 and Ketoconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- Dec 2008to Mar 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- body mass index (BMI) between 19 to 30 kg/m2 and body weight between 50 to 100 kg inclusive
Who cannot join
- Significant illness, trauma or surgical procedures.
- Clinically significant laboratory abnormalities.
- Clinically significant medical history
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
- Conditions
- Healthy
- Being tested
- AZD0837, Ketoconazole
- Keywords
- pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD0837Drug
Oral solution, dosing through the Loc-I-Gut catheter, single dose
KetoconazoleDrug
tablets, orally, once daily for 3 days
ketoconazoleDrug
dissolved tablets, dosing through the Loc-I-Gut catheter, single dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: AZD0837 |
| 2 | Active comparator | AZD0837 + Ketoconazole Receives: Drug: AZD0837; Drug: Ketoconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of AZD0837, AR-H069927XX, and AR-H067637XX in bile and biliary clearance of AZD0837, AR-H069927XX, and AR-H067637XX.
Measured: 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.
Measured: Frequent sampling during 24 hours.
Adverse events, physical examination, safety laboratory variables, blood pressure, pulse and electrocardiography.
Measured: Some of the safety variables will be followed at each visit, some less frequent.
Pharmacogenetics
Measured: One sampling during the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Lars Knutson, MD, PhD, Principal investigator, Inst för Kirurgiska VetenskaperUppsala Universitet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00812344
- Sponsor's protocol ID
- D1250C00029
- Status last verified
- Dec 2010
- First submitted
- 19 Dec 2008
- Last updated
- 3 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00812344
- Acronym / sponsor ID
- D1250C00029
- Conditions
- Healthy
- Keywords
- pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 22 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD0837 |
| 2 | Active comparator | Drug: AZD0837, Drug: KetoconazoleAZD0837 + Ketoconazole |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- body mass index (BMI) between 19 to 30 kg/m2 and body weight between 50 to 100 kg inclusive
Key exclusion criteria (3 listed)
- Significant illness, trauma or surgical procedures.
- Clinically significant laboratory abnormalities.
- Clinically significant medical history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD0837Oral solution, dosing through the Loc-I-Gut catheter, single dose | Drug | 1, 2 |
| Ketoconazoletablets, orally, once daily for 3 days | Drug | 2 |
| ketoconazoledissolved tablets, dosing through the Loc-I-Gut catheter, single dose | Drug | 2 |
Primary outcome
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.
3 secondary outcomes
PK variables of AZD0837, AR-H069927XX, and AR-H067637XX.
Time frame: Frequent sampling during 24 hours.
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.
Pharmacogenetics
Time frame: One sampling during the study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars Knutson, MD, PhD principal investigator
Inst för Kirurgiska VetenskaperUppsala Universitet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD0837 and Ketoconazole in people with Healthy, run by AstraZeneca at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2010.