Drug InteractionPhase 1NCT01254461
A Drug-Drug Interaction Study Between AZD1981 and Pravastatin to Study the Effect of AZD1981 on the Kinetics of Pravastatin
A Phase 1 study testing AZD1981 and pravastatin in people with Drug Interaction, run by AstraZeneca at 1 site in Sweden.
Trial summary
The primary purpose of this study is to determine whether the treatment with AZD1981 will affect the pharmacokinetics of pravastatin. 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
- Drug Interaction
- What is being tested?
- AZD1981 and pravastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2011to Apr 2011
- 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
- Healthy male volunteers aged 18 to 55, inclusive
- Have a body mass index between 19 and 30 kg/m2 and weight at least 50 kg and no more than 100 kg, inclusive
- 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
- 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 Via Tablet) for Eight Days and Single Doses of Pravastatin (Pravachol® Tablet 40 mg) to Evaluate the Pharmacokinetic Interaction of AZD1981 and Pravastatin in Healthy Male Volunteers
The primary purpose of this study is to determine whether the treatment with AZD1981 will affect the pharmacokinetics of pravastatin.
- Conditions
- Drug Interaction
- Being tested
- AZD1981, pravastatin
- Keywords
- Phase 1, Drug-Drug interaction, pravastatin, AZD1981, The pharmacokinetics resulting from AZD1981 and pravastatin interaction, The effects of taking a combination of AZD1981 and pravastatin
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 8 days
AZD1981Drug
4x100 mg per oral, twice daily for 8 days
pravastatinDrug
Also called pravachol
40 mg, once daily at Day 1, period A and Day 8, period B
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: AZD1981; Drug: pravastatin |
| B | Experimental | Not described Receives: Drug: AZD1981; Drug: pravastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics for pravastatin measured by Cmax and AUC
Pharmacokinetics for pravastatin measured by Cmax and AUC
Measured: Pharmacokinetic (PK) sampling will be performed on Day 1, period A and on Day 7-8, period B
Secondary outcomes (3)
AUC
Pharmacokinetics for pravastatin measured by AUC[0-t],Cmax (tmax), CL/F, t1/2λz, Vz/F, MRT
Measured: PK sampling will be performed on Day 1, period A and on Day 7-8, period B
AUCτ
Pharmacokinetics for AZD1981 measured by AUCτ,Css,max, Css, max (tmax ss), CLss/F, t1/2λz, Vz/F, MRT
Measured: PK sampling will be performed on Day 7 and Day 8, period B
Safety and tolerability
Safety and tolerability of AZD1981
Measured: Safety will be monitored continously 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 posted6 Dec 2010 (estimated)
- Study startFeb 2011
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug InteractionStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01254461
- Sponsor's protocol ID
- D9830C00016
- Other IDs
- 2010-023876-14
- Status last verified
- Apr 2011
- First submitted
- 3 Dec 2010
- Last updated
- 29 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 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 Via Tablet) for Eight Days and Single Doses of Pravastatin (Pravachol® Tablet 40 mg) to Evaluate the Pharmacokinetic Interaction of AZD1981 and Pravastatin in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01254461
- Acronym / sponsor ID
- D9830C00016
- Conditions
- Drug Interaction
- Keywords
- Phase 1, Drug-Drug interaction, pravastatin, AZD1981, The pharmacokinetics resulting from AZD1981 and pravastatin interaction, The effects of taking a combination of AZD1981 and pravastatin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 6 Dec 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 will affect the pharmacokinetics of pravastatin.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: AZD1981, Drug: pravastatin |
| B | Experimental | Drug: AZD1981, Drug: pravastatin |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male volunteers aged 18 to 55, inclusive
- Have a body mass index between 19 and 30 kg/m2 and weight at least 50 kg and no more than 100 kg, inclusive
- 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 (2 listed)
- 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 8 days | Drug | A |
| AZD19814x100 mg per oral, twice daily for 8 days | Drug | B |
| pravastatinAlso: pravachol40 mg, once daily at Day 1, period A and Day 8, period B | Drug | A, B |
Primary outcome
Pharmacokinetics for pravastatin measured by Cmax and AUC
Time frame: Pharmacokinetic (PK) sampling will be performed on Day 1, period A and on Day 7-8, period B
Pharmacokinetics for pravastatin measured by Cmax and AUC
3 secondary outcomes
AUC
Time frame: PK sampling will be performed on Day 1, period A and on Day 7-8, period B
AUCτ
Time frame: PK sampling will be performed on Day 7 and Day 8, period B
Safety and tolerability
Time frame: Safety will be monitored continously 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 29 Apr 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.
The record lists no contact. Use the official record to reach the sponsor.
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 pravastatin in people with Drug Interaction, 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 4 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 29 Apr 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 pravastatin measured by Cmax and AUC (time frame: Pharmacokinetic (PK) sampling will be performed on Day 1, period A and on Day 7-8, period B). 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 Apr 2011.