HealthyPhase 1NCT01330758

A Study to Compare Two Different Tablet Formulations of AZD8931 in Healthy Males and Females

A Phase 1 study testing AZD8931 in people with Healthy, run by AstraZeneca at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

A study to compare two different tablet formulations of AZD8931 in healthy males and females. 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?: AZD8931
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 1 siteUnited Kingdom
Study dates: Apr 2011to May 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

Male or female subjects aged 18 to 55 years
Females must have a negative pregnancy test at screening and on admission to the unit, must not be lactating and must be of non-child bearing potential
Body mass index between 19 and 30 kg/m2 and weight at least 50 kg and no more than 100 kg
Male subjects must be willing to use barrier methods of contraception
Be willing and able to comply with study procedures, restrictions and requirements

Who cannot join

History of any clinically significant disease or disorder
Any clinically significant abnormalities at screening
Use of any prescribed or non-prescribed medication within 2 weeks
Receipt of another NCE or participation in any other clinical trial within 3 months
Subjects who have previously received AZD8931

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Research Site
London

Other trials in United Kingdom

About this study

Official title: A Phase I, Randomised, Open-label, Cross-over, Single-centre Study in Healthy Male and Non-fertile Female Volunteers to Determine the Relative Bioavailability of the Phase II Wet Granulation Tablet Formulation Compared to the Phase II/III Roller Compacted Tablet Formulation of AZD8931

A study to compare two different tablet formulations of AZD8931 in healthy males and females.

Conditions: Healthy
Being tested: AZD8931
Keywords: Phase I, Healthy male and non-fertile female volunteers, Bioavailability, AZD8931

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AZD8931Drug
40 mg AZD8931 wet granulation tablet formulation
AZD8931Drug
40 mg AZD8931 roller compacted tablet formulation

Study groups in NCT01330758
Study group	Role	What they receive
40 mg AZD8931 wet granulation tablet formulation	Active comparator	Not described Receives: Drug: AZD8931
40 mg AZD8931 roller compacted tablet formulation	Experimental	Not described Receives: Drug: AZD8931

What is being measured

The primary outcome is the main question the study is designed to answer.

To determine the relative bioavailability of 40 mg AZD8931 Phase II wet granulation tablet formulation in relation to the 40mg AZD8931 Phase II/III roller compacted tablet formulation.
Measured: Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period

Secondary outcomes (1)

To further investigate the safety and tolerability variables (adverse events,vital signs, ECG, physical examination, safety labs).
Measured: From screening period through to 5 to 10 days after visit 3. An average time of 7 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2011May 2011

First posted7 Apr 2011 (estimated)
Study startApr 2011
Primary completionMay 2011
Study completionMay 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
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 26 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01330758
Sponsor's protocol ID: D0102C00005
Status last verified: Jul 2011
First submitted: 22 Mar 2011
Last updated: 29 Jul 2011
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 29 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Randomised, Open-label, Cross-over, Single-centre Study in Healthy Male and Non-fertile Female Volunteers to Determine the Relative Bioavailability of the Phase II Wet Granulation Tablet Formulation Compared to the Phase II/III Roller Compacted Tablet Formulation of AZD8931
ClinicalTrials.gov ID: NCT01330758
Acronym / sponsor ID: D0102C00005
Conditions: Healthy
Keywords: Phase I, Healthy male and non-fertile female volunteers, Bioavailability, AZD8931
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (estimated)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Apr 2011
Primary completion: May 2011 (actual)
Study completion: May 2011 (actual)
First posted: 7 Apr 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.

A study to compare two different tablet formulations of AZD8931 in healthy males and females.

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
40 mg AZD8931 wet granulation tablet formulation	Active comparator	Drug: AZD8931
40 mg AZD8931 roller compacted tablet formulation	Experimental	Drug: AZD8931

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Male or female subjects aged 18 to 55 years
Females must have a negative pregnancy test at screening and on admission to the unit, must not be lactating and must be of non-child bearing potential
Body mass index between 19 and 30 kg/m2 and weight at least 50 kg and no more than 100 kg
Male subjects must be willing to use barrier methods of contraception
Be willing and able to comply with study procedures, restrictions and requirements

Key exclusion criteria (5 listed)

History of any clinically significant disease or disorder
Any clinically significant abnormalities at screening
Use of any prescribed or non-prescribed medication within 2 weeks
Receipt of another NCE or participation in any other clinical trial within 3 months
Subjects who have previously received AZD8931

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
AZD893140 mg AZD8931 wet granulation tablet formulation	Drug	40 mg AZD8931 wet granulation tablet formulation
AZD893140 mg AZD8931 roller compacted tablet formulation	Drug	40 mg AZD8931 roller compacted tablet formulation

Primary outcome

To determine the relative bioavailability of 40 mg AZD8931 Phase II wet granulation tablet formulation in relation to the 40mg AZD8931 Phase II/III roller compacted tablet formulation.
Time frame: Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period

1 secondary outcome

To further investigate the safety and tolerability variables (adverse events,vital signs, ECG, physical examination, safety labs).
Time frame: From screening period through to 5 to 10 days after visit 3. An average time of 7 weeks.

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 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.

Mary Stuart study director

AstraZeneca,1F64, Mereside, Alderley Park, Macclesfield, Cheshire,SK10 4TG UK

Dr Darren Wilbraham, DICP, MBBS principal investigator

Quintiles Drug Research Unit at Guy's Hospital

Jason Clark, BSc study director

Quintiles Drug Research Unit at Guy's Hospital

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 AZD8931 in people with Healthy, run by AstraZeneca at 1 site in United Kingdom.

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 5 inclusion and 5 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 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 United Kingdom. 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?

To determine the relative bioavailability of 40 mg AZD8931 Phase II wet granulation tablet formulation in relation to the 40mg AZD8931 Phase II/III roller compacted tablet formulation. (time frame: Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01330758.

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 Jul 2011.