PharmakokineticPhase 1NCT01199341
A Drug-Drug Interaction Study to Study the Effect of AZD1981 on Warfarin
A Phase 1 study testing AZD1981 and Warfarin in people with Pharmakokinetic, run by AstraZeneca at 1 site in Sweden.
Trial summary
The primary purpose of this study is to determine whether the treatment with AZD1981 affect the exposure of Warfarin. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pharmakokinetic
- What is being tested?
- AZD1981 and Warfarin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2010to Dec 2010
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Have a body mass index between 19 and 30 kg/m2 and weight at least 65 kg and no more than 100 kg
- Be a non-smoker or ex-smoker who has stopped smoking for >6 months prior to screening
- Volunteers must be willing to use barrier methods of contraception during study and 3 months after the end of their participation in the study
Who cannot join
- Volunteer that is inferred to have an increased sensitivity to warfarin based on genotype of CYP2C9 and VKORC1.
- Any clinically significant disease or disorder
- Any clinically relevant abnormal findings in physical examination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open Label, Randomised, Parallel Group Study of Repeated Oral Doses of AZD1981 (100 mg Twice Daily and 400 mg Twice Daily) for Two Weeks and Single Doses of Warfarin (25 mg) to Evaluate the Pharmacokinetic Interaction of AZD1981 and Warfarin and the Effect of AZD1981 on Warfarin Pharmacodynamics in Healthy Male Volunteers
The primary purpose of this study is to determine whether the treatment with AZD1981 affect the exposure of Warfarin.
- Conditions
- Pharmakokinetic
- Being tested
- AZD1981, Warfarin
- Keywords
- Phase 1, Drug-Drug interaction, warfarin, AZD1981
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD1981Drug
100 mg per oral, twice daily for 14 days
WarfarinDrug
Also called Waran
10 x 2.5 mg per oral, once daily at day 1 and day 15
AZD1981Drug
4 x 100 mg per oral, twice daily for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | AZD1981, low dose, + Warfarin Receives: Drug: AZD1981; Drug: Warfarin |
| Treatment B | Experimental | AZD1981, high dose, + Warfarin Receives: Drug: Warfarin; Drug: AZD1981 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics for (R)- and (S)-Warfarin, respectively measured by Cmax and Area Under the Curve (AUC)
Measured: PK sampling will be performed regularly from Day 1 to Day 22
Secondary outcomes (3)
Explore possible changes in the anticoagulative activity of Warfarin measured by INR .
Measured: Will be performed at screening and at all visits during the study period.
Pharmacokinetics for AZD1981 measured by AUCτ, Css,max, tmax,ss and CLss/F
Measured: PK sampling will be performed regularly from Day 15 to Day 22.
Safety and tolerability of AZD1981
Measured: Safety will be monitored continuously and safety assessments will be made on several occasions throughout the whole study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmakokineticStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Christer Hultqvist, MD, Study director, AstraZenecaAslak Rautio, Principal investigator, Quintiles ABWofgang Kühn, MD, Principal investigator, Quintiles AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01199341
- Sponsor's protocol ID
- D9830C00017
- Other IDs
- 2010-021956-24
- Status last verified
- Feb 2011
- First submitted
- 9 Sep 2010
- Last updated
- 9 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open Label, Randomised, Parallel Group Study of Repeated Oral Doses of AZD1981 (100 mg Twice Daily and 400 mg Twice Daily) for Two Weeks and Single Doses of Warfarin (25 mg) to Evaluate the Pharmacokinetic Interaction of AZD1981 and Warfarin and the Effect of AZD1981 on Warfarin Pharmacodynamics in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01199341
- Acronym / sponsor ID
- D9830C00017
- Conditions
- Pharmakokinetic
- Keywords
- Phase 1, Drug-Drug interaction, warfarin, AZD1981
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 10 Sep 2010 (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 primary purpose of this study is to determine whether the treatment with AZD1981 affect the exposure of Warfarin.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: AZD1981, Drug: WarfarinAZD1981, low dose, + Warfarin |
| Treatment B | Experimental | Drug: Warfarin, Drug: AZD1981AZD1981, high dose, + Warfarin |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Have a body mass index between 19 and 30 kg/m2 and weight at least 65 kg and no more than 100 kg
- Be a non-smoker or ex-smoker who has stopped smoking for >6 months prior to screening
- Volunteers must be willing to use barrier methods of contraception during study and 3 months after the end of their participation in the study
Key exclusion criteria (3 listed)
- Volunteer that is inferred to have an increased sensitivity to warfarin based on genotype of CYP2C9 and VKORC1.
- Any clinically significant disease or disorder
- Any clinically relevant abnormal findings in physical examination
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 |
|---|---|---|
| AZD1981100 mg per oral, twice daily for 14 days | Drug | Treatment A |
| WarfarinAlso: Waran10 x 2.5 mg per oral, once daily at day 1 and day 15 | Drug | Treatment A, Treatment B |
| AZD19814 x 100 mg per oral, twice daily for 14 days | Drug | Treatment B |
Primary outcome
Pharmacokinetics for (R)- and (S)-Warfarin, respectively measured by Cmax and Area Under the Curve (AUC)
Time frame: PK sampling will be performed regularly from Day 1 to Day 22
3 secondary outcomes
Explore possible changes in the anticoagulative activity of Warfarin measured by INR .
Time frame: Will be performed at screening and at all visits during the study period.
Pharmacokinetics for AZD1981 measured by AUCτ, Css,max, tmax,ss and CLss/F
Time frame: PK sampling will be performed regularly from Day 15 to Day 22.
Safety and tolerability of AZD1981
Time frame: Safety will be monitored continuously and safety assessments will be made on several occasions throughout the whole 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 9 Feb 2011.
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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.
Christer Hultqvist, MD study director
AstraZeneca
Aslak Rautio principal investigator
Quintiles AB
Wofgang Kühn, MD principal investigator
Quintiles AB
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 AZD1981 and Warfarin in people with Pharmakokinetic, 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 3 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 9 Feb 2011. 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?
Pharmacokinetics for (R)- and (S)-Warfarin, respectively measured by Cmax and Area Under the Curve (AUC) (time frame: PK sampling will be performed regularly from Day 1 to Day 22). 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 9 Feb 2011; AzTrials last refreshed its copy on 30 Oct 2026.