PharmacokineticsPhase 1NCT01214122
A Drug-Drug Interaction Study Between AZD9668 and Warfarin to Study the Effect of AZD9668 on the Metabolism and Effect of Warfarin
A Phase 1 study testing AZD9668 and Warfarin in people with Pharmacokinetics and Pharmacodynamics, run by AstraZeneca at 2 sites in Sweden.
Trial summary
The primary purpose of this study is to determine whether the treatment with AZD9668 will affect the metabolism and effect 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
- Pharmacokinetics, Pharmacodynamics
- What is being tested?
- AZD9668 and Warfarin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesSweden
- Study dates
- Nov 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
- Provision of signed informed consent (including genotyping screening sample for CYP2C9 and VKORC1) prior to any study specific procedures
- Subjects must be willing to use a barrier method of contraception, unless their partners are post-menopausal or surgically sterile, or if a female partner is of childbearing potential the subject must use a barrier method of contraception (condom) and the partner must use accepted contraceptive methods (oral contraceptive, implant, long term injectable contraceptive or intrauterine device), from first dose of IP (warfarin and AZD9668) until 3 months after last dose of IP (warfarin and AZD9668)
- Have a body mass index between 19 and 30 kg/m2 (inclusive) and a weight between 50 and 100 kg (inclusive)
- Be a non-smoker or ex-smoker who has stopped smoking for >6 months prior to Visit 1.
Who cannot join
- Any clinically significant disease or disorder
- Subject predicted to have high sensitivity to warfarin based on CYP2C9 and VKORC1 genotypes
- Any clinically relevant abnormal findings in physical examination
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Phase I, Open Label, Fixed Sequence, Single Centre Study in Healthy Volunteers to Investigate the Effects of Repeated Oral Doses AZD9668 on the Pharmacokinetics and Pharmacodynamics of a Single Dose of Warfarin
The primary purpose of this study is to determine whether the treatment with AZD9668 will affect the metabolism and effect of Warfarin.
- Conditions
- Pharmacokinetics, Pharmacodynamics
- Being tested
- AZD9668, Warfarin
- Keywords
- Phase 1, Drug-Drug interaction, warfarin, AZD9668, resulting from AZD9668 and Warfarin interaction, pharmacokinetics, pharmacodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD9668Drug
60 mg orally twice daily for 11 days
WarfarinDrug
10 x 2.5 (25) mg orally once daily on day 1 and on day 14
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | AZD9668 - 2 x30mg tablets Receives: Drug: AZD9668 |
| Treatment B | Experimental | Warfarin - 10 x2.5 mg tablets Receives: Drug: Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)
Measured: Pharmacokinetic (PK) sampling will be performed day 1
Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)
Measured: Pharmacokinetic (PK) sampling will be performed day 2
Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)
Measured: Pharmacokinetic (PK) sampling will be performed day 3
Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)
Measured: Pharmacokinetic (PK) sampling will be performed day 4
Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)
Measured: Pharmacokinetic (PK) sampling will be performed day 5
Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)
Measured: Pharmacokinetic (PK) sampling will be performed day 6
Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)
Measured: Pharmacokinetic (PK) sampling will be performed day 7
Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)
Measured: Pharmacokinetic (PK) sampling will be performed day 8
Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)
Measured: Pharmacokinetic (PK) sampling will be performed day 9
Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)
Measured: Pharmacokinetic (PK) sampling will be performed day 10
Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)
Measured: Pharmacokinetic (PK) sampling will be performed day 11
Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)
Measured: Pharmacokinetic (PK) sampling will be performed day 12
Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)
Measured: Pharmacokinetic (PK) sampling will be performed day 13
Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)
Measured: Pharmacokinetic (PK) sampling will be performed day 14
Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)
Measured: Pharmacokinetic (PK) sampling will be performed day 15
Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)
Measured: Pharmacokinetic (PK) sampling will be performed day 16
Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)
Measured: Pharmacokinetic (PK) sampling will be performed day 17
Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)
Measured: Pharmacokinetic (PK) sampling will be performed day 18
Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)
Measured: Pharmacokinetic (PK) sampling will be performed day 19
Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)
Measured: Pharmacokinetic (PK) sampling will be performed day 20
Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)
Measured: Pharmacokinetic (PK) sampling will be performed day 21
Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)
Measured: Pharmacokinetic (PK) sampling will be performed day 22
Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)
Measured: Pharmacokinetic (PK) sampling will be performed day 23
Pharmacodynamics measured by maximum international normalised ratio ( INRmax)
Measured: International normalised ratio (INR) sampling will be performed day 1
Pharmacodynamics measured by maximum international normalised ratio ( INRmax)
Measured: International normalised ratio (INR) sampling will be performed day 2
Pharmacodynamics measured by maximum international normalised ratio ( INRmax)
Measured: International normalised ratio (INR) sampling will be performed day 3
Pharmacodynamics measured by maximum international normalised ratio ( INRmax)
Measured: International normalised ratio (INR) sampling will be performed day 4
Pharmacodynamics measured by maximum international normalised ratio ( INRmax)
Measured: International normalised ratio (INR) sampling will be performed day 5
Pharmacodynamics measured by maximum international normalised ratio ( INRmax)
Measured: International normalised ratio (INR) sampling will be performed day 6
Pharmacodynamics measured by maximum international normalised ratio ( INRmax)
Measured: International normalised ratio (INR) sampling will be performed day 7
Pharmacodynamics measured by maximum international normalised ratio ( INRmax)
Measured: International normalised ratio (INR) sampling will be performed day 8
Pharmacodynamics measured by maximum international normalised ratio ( INRmax)
Measured: International normalised ratio (INR) sampling will be performed day 9
Pharmacodynamics measured by maximum international normalised ratio ( INRmax)
Measured: International normalised ratio (INR) sampling will be performed day 10
Pharmacodynamics measured by maximum international normalised ratio ( INRmax)
Measured: International normalised ratio (INR) sampling will be performed day 11
Pharmacodynamics measured by maximum international normalised ratio ( INRmax)
Measured: International normalised ratio (INR) sampling will be performed day 12
Pharmacodynamics measured by maximum international normalised ratio ( INRmax)
Measured: International normalised ratio (INR) sampling will be performed day 13
Pharmacodynamics measured by maximum international normalised ratio ( INRmax)
Measured: International normalised ratio (INR) sampling will be performed day 14
Pharmacodynamics measured by maximum international normalised ratio ( INRmax)
Measured: International normalised ratio (INR) sampling will be performed day 15
Pharmacodynamics measured by maximum international normalised ratio ( INRmax)
Measured: International normalised ratio (INR) sampling will be performed day 16
Pharmacodynamics measured by maximum international normalised ratio ( INRmax)
Measured: International normalised ratio (INR) sampling will be performed day 17
Pharmacodynamics measured by maximum international normalised ratio ( INRmax)
Measured: International normalised ratio (INR) sampling will be performed day 18
Pharmacodynamics measured by maximum international normalised ratio ( INRmax)
Measured: International normalised ratio (INR) sampling will be performed day 19
Pharmacodynamics measured by maximum international normalised ratio ( INRmax)
Measured: International normalised ratio (INR) sampling will be performed day 20
Pharmacodynamics measured by maximum international normalised ratio ( INRmax)
Measured: International normalised ratio (INR) sampling will be performed day 21
Pharmacodynamics measured by maximum international normalised ratio ( INRmax)
Measured: International normalised ratio (INR) sampling will be performed day 22
Pharmacodynamics measured by maximum international normalised ratio ( INRmax)
Measured: International normalised ratio (INR) sampling will be performed day 23
Secondary outcomes (10)
Pharmacokinetics for AZD9668 measured by Css,max
Measured: Range from day 9 to 23
Pharmacokinetics for AZD9668 measured by tss,max
Measured: Range from day 9 to 23
Pharmacokinetics for AZD9668 measured by Css,min
Measured: Range from day 9 to 23
Pharmacokinetics for AZD9668 measured by CLss/F
Measured: Range from day 9 to 23
Severity of Adverse Events as a Measure of Safety and Tolerability
Measured: Adverse events will be collected pre-dose, during treatment and at follow up
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: Adverse events will be collected pre-dose, during treatment and at follow up
Pharmacokinetics for (R)- and (S)- Warfarin measured tmax.
Measured: Range from day 1 to 23
Pharmacokinetics for (R)- and (S)- Warfarin measured t½.
Measured: Range from day 1 to 23
Pharmacokinetics for (R)- and (S)- Warfarin measured CL/F.
Measured: Range from day 1 to 23
Pharmacokinetics for (R)- and (S)- Warfarin measured Vz/F.
Measured: Range from day 1 to 23
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2010 (estimated)
- Study startNov 2010
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Christopher D O'Brien, MD, PhD, Study director, AstraZeneca R&DIngemar Bylesjö, MD, Principal investigator, Berzelius Clinical Reseach CentreWolfgang Kühn, MD, Principal investigator, Quintiles AB, Phase 1 Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01214122
- Sponsor's protocol ID
- D0520C00013
- Other IDs
- 2010-022360-12
- Status last verified
- Jan 2013
- First submitted
- 21 Sep 2010
- Last updated
- 29 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open Label, Fixed Sequence, Single Centre Study in Healthy Volunteers to Investigate the Effects of Repeated Oral Doses AZD9668 on the Pharmacokinetics and Pharmacodynamics of a Single Dose of Warfarin
- ClinicalTrials.gov ID
- NCT01214122
- Acronym / sponsor ID
- D0520C00013
- Conditions
- Pharmacokinetics, Pharmacodynamics
- Keywords
- Phase 1, Drug-Drug interaction, warfarin, AZD9668, resulting from AZD9668 and Warfarin interaction, pharmacokinetics, pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 4 Oct 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 AZD9668 will affect the metabolism and effect of Warfarin.
Study design
- Primary purpose
- Basic science
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: AZD9668AZD9668 - 2 x30mg tablets |
| Treatment B | Experimental | Drug: WarfarinWarfarin - 10 x2.5 mg tablets |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Provision of signed informed consent (including genotyping screening sample for CYP2C9 and VKORC1) prior to any study specific procedures
- Subjects must be willing to use a barrier method of contraception, unless their partners are post-menopausal or surgically sterile, or if a female partner is of childbearing potential the subject must use a barrier method of contraception (condom) and the partner must use accepted contraceptive methods (oral contraceptive, implant, long term injectable contraceptive or intrauterine device), from first dose of IP (warfarin and AZD9668) until 3 months after last dose of IP (warfarin and AZD9668)
- Have a body mass index between 19 and 30 kg/m2 (inclusive) and a weight between 50 and 100 kg (inclusive)
- Be a non-smoker or ex-smoker who has stopped smoking for >6 months prior to Visit 1.
Key exclusion criteria (3 listed)
- Any clinically significant disease or disorder
- Subject predicted to have high sensitivity to warfarin based on CYP2C9 and VKORC1 genotypes
- 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 |
|---|---|---|
| AZD966860 mg orally twice daily for 11 days | Drug | Treatment A |
| Warfarin10 x 2.5 (25) mg orally once daily on day 1 and on day 14 | Drug | Treatment B |
Primary outcome
Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)
Time frame: Pharmacokinetic (PK) sampling will be performed day 1
Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)
Time frame: Pharmacokinetic (PK) sampling will be performed day 2
Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)
Time frame: Pharmacokinetic (PK) sampling will be performed day 3
Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)
Time frame: Pharmacokinetic (PK) sampling will be performed day 4
Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)
Time frame: Pharmacokinetic (PK) sampling will be performed day 5
Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)
Time frame: Pharmacokinetic (PK) sampling will be performed day 6
Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)
Time frame: Pharmacokinetic (PK) sampling will be performed day 7
Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)
Time frame: Pharmacokinetic (PK) sampling will be performed day 8
Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)
Time frame: Pharmacokinetic (PK) sampling will be performed day 9
Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)
Time frame: Pharmacokinetic (PK) sampling will be performed day 10
Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)
Time frame: Pharmacokinetic (PK) sampling will be performed day 11
Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)
Time frame: Pharmacokinetic (PK) sampling will be performed day 12
Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)
Time frame: Pharmacokinetic (PK) sampling will be performed day 13
Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)
Time frame: Pharmacokinetic (PK) sampling will be performed day 14
Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)
Time frame: Pharmacokinetic (PK) sampling will be performed day 15
Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)
Time frame: Pharmacokinetic (PK) sampling will be performed day 16
Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)
Time frame: Pharmacokinetic (PK) sampling will be performed day 17
Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)
Time frame: Pharmacokinetic (PK) sampling will be performed day 18
Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)
Time frame: Pharmacokinetic (PK) sampling will be performed day 19
Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)
Time frame: Pharmacokinetic (PK) sampling will be performed day 20
Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)
Time frame: Pharmacokinetic (PK) sampling will be performed day 21
Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)
Time frame: Pharmacokinetic (PK) sampling will be performed day 22
Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)
Time frame: Pharmacokinetic (PK) sampling will be performed day 23
Pharmacodynamics measured by maximum international normalised ratio ( INRmax)
Time frame: International normalised ratio (INR) sampling will be performed day 1
Pharmacodynamics measured by maximum international normalised ratio ( INRmax)
Time frame: International normalised ratio (INR) sampling will be performed day 2
Pharmacodynamics measured by maximum international normalised ratio ( INRmax)
Time frame: International normalised ratio (INR) sampling will be performed day 3
Pharmacodynamics measured by maximum international normalised ratio ( INRmax)
Time frame: International normalised ratio (INR) sampling will be performed day 4
Pharmacodynamics measured by maximum international normalised ratio ( INRmax)
Time frame: International normalised ratio (INR) sampling will be performed day 5
Pharmacodynamics measured by maximum international normalised ratio ( INRmax)
Time frame: International normalised ratio (INR) sampling will be performed day 6
Pharmacodynamics measured by maximum international normalised ratio ( INRmax)
Time frame: International normalised ratio (INR) sampling will be performed day 7
Pharmacodynamics measured by maximum international normalised ratio ( INRmax)
Time frame: International normalised ratio (INR) sampling will be performed day 8
Pharmacodynamics measured by maximum international normalised ratio ( INRmax)
Time frame: International normalised ratio (INR) sampling will be performed day 9
Pharmacodynamics measured by maximum international normalised ratio ( INRmax)
Time frame: International normalised ratio (INR) sampling will be performed day 10
Pharmacodynamics measured by maximum international normalised ratio ( INRmax)
Time frame: International normalised ratio (INR) sampling will be performed day 11
Pharmacodynamics measured by maximum international normalised ratio ( INRmax)
Time frame: International normalised ratio (INR) sampling will be performed day 12
Pharmacodynamics measured by maximum international normalised ratio ( INRmax)
Time frame: International normalised ratio (INR) sampling will be performed day 13
Pharmacodynamics measured by maximum international normalised ratio ( INRmax)
Time frame: International normalised ratio (INR) sampling will be performed day 14
Pharmacodynamics measured by maximum international normalised ratio ( INRmax)
Time frame: International normalised ratio (INR) sampling will be performed day 15
Pharmacodynamics measured by maximum international normalised ratio ( INRmax)
Time frame: International normalised ratio (INR) sampling will be performed day 16
Pharmacodynamics measured by maximum international normalised ratio ( INRmax)
Time frame: International normalised ratio (INR) sampling will be performed day 17
Pharmacodynamics measured by maximum international normalised ratio ( INRmax)
Time frame: International normalised ratio (INR) sampling will be performed day 18
Pharmacodynamics measured by maximum international normalised ratio ( INRmax)
Time frame: International normalised ratio (INR) sampling will be performed day 19
Pharmacodynamics measured by maximum international normalised ratio ( INRmax)
Time frame: International normalised ratio (INR) sampling will be performed day 20
Pharmacodynamics measured by maximum international normalised ratio ( INRmax)
Time frame: International normalised ratio (INR) sampling will be performed day 21
Pharmacodynamics measured by maximum international normalised ratio ( INRmax)
Time frame: International normalised ratio (INR) sampling will be performed day 22
Pharmacodynamics measured by maximum international normalised ratio ( INRmax)
Time frame: International normalised ratio (INR) sampling will be performed day 23
10 secondary outcomes
Pharmacokinetics for AZD9668 measured by Css,max
Time frame: Range from day 9 to 23
Pharmacokinetics for AZD9668 measured by tss,max
Time frame: Range from day 9 to 23
Pharmacokinetics for AZD9668 measured by Css,min
Time frame: Range from day 9 to 23
Pharmacokinetics for AZD9668 measured by CLss/F
Time frame: Range from day 9 to 23
Severity of Adverse Events as a Measure of Safety and Tolerability
Time frame: Adverse events will be collected pre-dose, during treatment and at follow up
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Adverse events will be collected pre-dose, during treatment and at follow up
Pharmacokinetics for (R)- and (S)- Warfarin measured tmax.
Time frame: Range from day 1 to 23
Pharmacokinetics for (R)- and (S)- Warfarin measured t½.
Time frame: Range from day 1 to 23
Pharmacokinetics for (R)- and (S)- Warfarin measured CL/F.
Time frame: Range from day 1 to 23
Pharmacokinetics for (R)- and (S)- Warfarin measured Vz/F.
Time frame: Range from day 1 to 23
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2013.
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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.
Christopher D O'Brien, MD, PhD study director
AstraZeneca R&D
Ingemar Bylesjö, MD principal investigator
Berzelius Clinical Reseach Centre
Wolfgang Kühn, MD principal investigator
Quintiles AB, Phase 1 Services
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD9668 and Warfarin in people with Pharmacokinetics and Pharmacodynamics, run by AstraZeneca at 2 sites 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 4 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: withdrawn, as of the sponsor's last update on 29 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was withdrawn before enrolling participants, so there are no results.
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, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC) (time frame: Pharmacokinetic (PK) sampling will be performed day 1). The study lists 46 primary outcomes in all. 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 29 Jan 2013.