HealthyPhase 1NCT00707551
An Interaction Study of Ketoconazole/Verapamil Versus AZD1305
A Phase 1 study testing Ketoconazole, Verapamil and AZD1305 in people with Healthy, run by AstraZeneca at 1 site in Germany.
Trial summary
The purpose is to study whether ketoconazole or verapamil have an effect on how AZD1305 is handled by the body, i.e the absorption, distribution, metabolism and excretion, when administered in combination with AZD1305. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ketoconazole, Verapamil and AZD1305
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2008to Nov 2008
- 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- A body mass index (BMI=weight/height2) of 19 to 30 kg/m2
Who cannot join
- Potassium outside normal reference values
- ECG findings outside normal range
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Single-centre, Randomised, Open, Three-way Crossover Study to Evaluate the Effect of Ketoconazole and Verapamil, Respectively, on the Pharmacokinetics of AZD1305 After Repeated Oral Adm of Ketoconazole and Verapamil and Single Oral Dosing of AZD1305 to Young Healthy Male Volunteers
The purpose is to study whether ketoconazole or verapamil have an effect on how AZD1305 is handled by the body, i.e the absorption, distribution, metabolism and excretion, when administered in combination with AZD1305.
- Conditions
- Healthy
- Being tested
- Ketoconazole, Verapamil, AZD1305
- Keywords
- AZD1305, Verapamil, Ketoconazole, pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetoconazoleDrug
Also called Fungoral
Tablet, administered as repeated doses.
VerapamilDrug
Also called Isoptin Retard
Extended Release tablet, administered as repeated doses.
AZD1305Drug
Extended Release tablet, administered as a single dose.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Ketoconazole tablet + AZD1305 Extended Release tablet Receives: Drug: Ketoconazole; Drug: AZD1305 |
| 2 | Experimental | Verapamil Extended Release tablet + AZD1305 Extended Release tablet Receives: Drug: Verapamil; Drug: AZD1305 |
| 3 | Experimental | AZD1305 Extended Release tablet Receives: Drug: AZD1305 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic variables
Measured: During all dosing visits
Secondary outcomes (1)
Adverse events, vital signs, ECG, laboratory variables and physical examination
Measured: 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 posted1 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionNov 2008
- Study completionNov 2008
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Helen Lunde, MD, Study director, AstraZeneca R&D, Mölndal, SwedenDago Mazur, MD, PhD, Principal investigator, PAREXEL International GmbH, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00707551
- Sponsor's protocol ID
- D3190C00009
- Other IDs
- 2008-000578-18 (EudraCT No), 2008
- Status last verified
- Dec 2010
- First submitted
- 27 Jun 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
- A Phase I, Single-centre, Randomised, Open, Three-way Crossover Study to Evaluate the Effect of Ketoconazole and Verapamil, Respectively, on the Pharmacokinetics of AZD1305 After Repeated Oral Adm of Ketoconazole and Verapamil and Single Oral Dosing of AZD1305 to Young Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT00707551
- Acronym / sponsor ID
- D3190C00009
- Conditions
- Healthy
- Keywords
- AZD1305, Verapamil, Ketoconazole, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 1 Jul 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.
The purpose is to study whether ketoconazole or verapamil have an effect on how AZD1305 is handled by the body, i.e the absorption, distribution, metabolism and excretion, when administered in combination with AZD1305.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Ketoconazole, Drug: AZD1305Ketoconazole tablet + AZD1305 Extended Release tablet |
| 2 | Experimental | Drug: Verapamil, Drug: AZD1305Verapamil Extended Release tablet + AZD1305 Extended Release tablet |
| 3 | Experimental | Drug: AZD1305AZD1305 Extended Release tablet |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- A body mass index (BMI=weight/height2) of 19 to 30 kg/m2
Key exclusion criteria (2 listed)
- Potassium outside normal reference values
- ECG findings outside normal range
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 |
|---|---|---|
| KetoconazoleAlso: FungoralTablet, administered as repeated doses. | Drug | 1 |
| VerapamilAlso: Isoptin RetardExtended Release tablet, administered as repeated doses. | Drug | 2 |
| AZD1305Extended Release tablet, administered as a single dose. | Drug | 1, 2, 3 |
Primary outcome
Pharmacokinetic variables
Time frame: During all dosing visits
1 secondary outcome
Adverse events, vital signs, ECG, laboratory variables and physical examination
Time frame: 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.
Helen Lunde, MD study director
AstraZeneca R&D, Mölndal, Sweden
Dago Mazur, MD, PhD principal investigator
PAREXEL International GmbH, Berlin, Germany
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 Ketoconazole, Verapamil and AZD1305 in people with Healthy, run by AstraZeneca at 1 site in Germany.
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 2 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 Germany. 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?
Pharmacokinetic variables (time frame: During all dosing visits). 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.