HealthyPhase 1NCT01311635
A Bioavailability Study Comparing 3 Different AZD1981 Tablets
A Phase 1 study testing AZD1981, current small-particle tablet, AZD1981, new small-particle tablet and AZD1981, new large-particle table in people with Healthy, run by AstraZeneca at 1 site in Sweden.
Trial summary
The purpose of this study is to study the relative bioavailability of AZD1981 when using a new tablet compared to the current tablet. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- AZD1981, current small-particle tablet, AZD1981, new small-particle tablet and AZD1981, new large-particle table
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2011to Jun 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and postmenopausal or surgically sterile female volunteers aged 18-55, inclusive
- Have a body mass index between 19-30 kg/m2 and weigh 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 contraceptive, unless their partners are post-menopausal, surgically sterile or using accepted contraceptive methods.
Who cannot join
- Any clinically significant disease or disorder
- Any clinically relevant abnormal findings in the physical examination, clinical chemistry, haematology, urinalysis, vital signs (including body temperature), or ECG assessments at Visit 1, or in vital signs (including body temperature) at Visit 2
- Prolonged QTcF >450 ms or shortened QTcF<340 ms at Visit 1 or family history of long QT syndrome
- History of, or current alcohol or drug abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open Label, Randomised, 4-way Crossover Study to Investigate the Relative Bioavailability of Single Dose AZD1981 Via 3 Different Tablets in Healthy Men and Healthy Women of Non-childbearing Potential
The purpose of this study is to study the relative bioavailability of AZD1981 when using a new tablet compared to the current tablet.
- Conditions
- Healthy
- Being tested
- AZD1981, current small-particle tablet, AZD1981, new small-particle tablet, AZD1981, new large-particle table
- Keywords
- Phase 1, bioavailability study, AZD1981, tablets, To study the relative bioavailability of single dose AZD1981 via three different tablets, To compare the bioavailability between three different AZD1981 tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD1981, current small-particle tabletDrug
3x100 mg per oral, single dose in fasted state
AZD1981, new small-particle tabletDrug
3x100 mg per oral, single dose
AZD1981, new large-particle tableDrug
3x100 mg per oral, single dose in fasted state
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Not described Receives: Drug: AZD1981, current small-particle tablet |
| Treatment B | Experimental | Not described Receives: Drug: AZD1981, new small-particle tablet |
| Treatment C | Experimental | Not described Receives: Drug: AZD1981, new small-particle tablet |
| Treatment D | Experimental | Not described Receives: Drug: AZD1981, new large-particle table |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the area under the plasma concentration time-curve from zero to infinity /AUC) and the maximum plasma concentration (Cmax) of AZD1981
Measured: Pharmacokinetic (PK) sampling continuously for 60 h after each single dose, ie day 1-3 for each period.
Secondary outcomes (2)
To evaluate basic systemic PK parameters as follows:
- AUC(0-t): area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration
- tmax: time to reach Cmax
- t1/2λz: terminal half-life
- CL/F: apparent plasma clearance
- MRT: apparent mean residence time
- Vz/F: apparent volume of distribution during terminal phase
Measured: PK sampling continuously for 60 h after each single dose, ie day 1-3 for each period
To evaluate the safety and tolerability of AZD1981 by assessment of adverse events, laboratory safety parameters, vital signs, ECG, physical examination and weight
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 posted9 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionMay 2011
- Study completionJun 2011
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Wolfgang Kühn, MD, Principal investigator, Quintiles AB, Phase 1 Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01311635
- Sponsor's protocol ID
- D9830C00020
- Status last verified
- Jul 2011
- First submitted
- 3 Mar 2011
- Last updated
- 7 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open Label, Randomised, 4-way Crossover Study to Investigate the Relative Bioavailability of Single Dose AZD1981 Via 3 Different Tablets in Healthy Men and Healthy Women of Non-childbearing Potential
- ClinicalTrials.gov ID
- NCT01311635
- Acronym / sponsor ID
- D9830C00020
- Conditions
- Healthy
- Keywords
- Phase 1, bioavailability study, AZD1981, tablets, To study the relative bioavailability of single dose AZD1981 via three different tablets, To compare the bioavailability between three different AZD1981 tablets
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- May 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 9 Mar 2011 (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 of this study is to study the relative bioavailability of AZD1981 when using a new tablet compared to the current tablet.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: AZD1981, current small-particle tablet |
| Treatment B | Experimental | Drug: AZD1981, new small-particle tablet |
| Treatment C | Experimental | Drug: AZD1981, new small-particle tablet |
| Treatment D | Experimental | Drug: AZD1981, new large-particle table |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male and postmenopausal or surgically sterile female volunteers aged 18-55, inclusive
- Have a body mass index between 19-30 kg/m2 and weigh 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 contraceptive, unless their partners are post-menopausal, surgically sterile or using accepted contraceptive methods.
Key exclusion criteria (4 listed)
- Any clinically significant disease or disorder
- Any clinically relevant abnormal findings in the physical examination, clinical chemistry, haematology, urinalysis, vital signs (including body temperature), or ECG assessments at Visit 1, or in vital signs (including body temperature) at Visit 2
- Prolonged QTcF >450 ms or shortened QTcF<340 ms at Visit 1 or family history of long QT syndrome
- History of, or current alcohol or drug abuse
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 |
|---|---|---|
| AZD1981, current small-particle tablet3x100 mg per oral, single dose in fasted state | Drug | Treatment A |
| AZD1981, new small-particle tablet3x100 mg per oral, single dose | Drug | Treatment B, Treatment C |
| AZD1981, new large-particle table3x100 mg per oral, single dose in fasted state | Drug | Treatment D |
Primary outcome
Assessment of the area under the plasma concentration time-curve from zero to infinity /AUC) and the maximum plasma concentration (Cmax) of AZD1981
Time frame: Pharmacokinetic (PK) sampling continuously for 60 h after each single dose, ie day 1-3 for each period.
2 secondary outcomes
To evaluate basic systemic PK parameters as follows:
Time frame: PK sampling continuously for 60 h after each single dose, ie day 1-3 for each period
To evaluate the safety and tolerability of AZD1981 by assessment of adverse events, laboratory safety parameters, vital signs, ECG, physical examination and weight
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 7 Jul 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.
Wolfgang Kühn, MD principal investigator
Quintiles AB, Phase 1 Services
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, current small-particle tablet, AZD1981, new small-particle tablet and AZD1981, new large-particle table 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 4 inclusion and 4 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 7 Jul 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?
Assessment of the area under the plasma concentration time-curve from zero to infinity /AUC) and the maximum plasma concentration (Cmax) of AZD1981 (time frame: Pharmacokinetic (PK) sampling continuously for 60 h after each single dose, ie day 1-3 for each period.). 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 7 Jul 2011; AzTrials last refreshed its copy on 28 Oct 2026.