Healthy VolunteersPhase 1BANCT02039180
Relative Bioavailability Study to Assess Two Solid Formulations Compared to an Oral Solution of AZD3293 in Healthy Male and Non-Fertile Female Subjects
A Phase 1 study testing AZD3293 oral solution, AZD3293 tablet formulation A and AZD3293 tablet formulation B in people with Healthy Volunteers and Pharmacologic Action, run by AstraZeneca at 1 site in United States.
Trial summary
This is an open-label, randomized, 3-period crossover, single dose study. Three (3) single doses of AZD3293 (2 different tablet formulations, and an oral solution) will be administered with a washout period of at least 1 week between the doses to investigate the relative bioavailability of AZD3293 after administration… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Pharmacologic Action
- What is being tested?
- AZD3293 oral solution, AZD3293 tablet formulation A and AZD3293 tablet formulation B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Mar 2014
- 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
- Provision of signed, written, and dated informed consent prior to any study-specific procedures
- Healthy subjects must be able to understand and be willing to comply with study procedures, restrictions, and requirements.
- Male and non-fertile female healthy subjects, aged 18 to 55 years
- Body weight ≥50 to ≤100 kg and body mass index (BMI) ≥19 to ≤30 kg/m2
- Clinically normal findings on physical examination in relation to age, as judged by the Investigator
Who cannot join
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
- History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
- History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder according to the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV), as assessed by the Mini-International Neuropsychiatric Interview (MINI)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label, Randomized, Single-dose, 3-period Cross-over, Relative Bioavailability Study to Assess Two Solid Formulations Compared to an Oral Solution of AZD3293 in Healthy Male and Non-Fertile Female Subjects
This is an open-label, randomized, 3-period crossover, single dose study. Three (3) single doses of AZD3293 (2 different tablet formulations, and an oral solution) will be administered with a washout period of at least 1 week between the doses to investigate the relative bioavailability of AZD3293 after administration via 2 tablet formulations compared with oral solution and to evaluate basic systemic pharmacokinetic parameters of the tablet formulations compared to the oral solution of AZD3293.
The safety and tolerability of AZD3293 in healthy subjects will also be assessed in the study. AZD3293 is being developed for the treatment of Alzheimer's disease
- Conditions
- Healthy Volunteers, Pharmacologic Action
- Being tested
- AZD3293 oral solution, AZD3293 tablet formulation A, AZD3293 tablet formulation B
- Keywords
- phase I, healthy volunteers, AZD3293, bioavailability, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD3293 oral solutionDrug
Also called Beta secretase inhibitor
Subjects will receive AZD3293 as a tablet (Formulation A; Formulation B) and solution as a single dose on Day 1, Day 8 or Day 15.
AZD3293 tablet formulation ADrug
Also called beta secretase inhibitor
Subjects will receive AZD3293 as a tablet (Formulation A; Formulation B) and a solution as a single dose on Day 1, Day 8, or Day 15.
AZD3293 tablet formulation BDrug
Also called Beta secretase inhibitor
Subjects will receive AZD3293 as a tablet (Formulation A; Formulation B) and a solution as a single dose on Day 1, Day 8 or Day 15.
| Study group | Role | What they receive |
|---|---|---|
| AZD3293 oral solution | Experimental | single doses in random order in 3 study periods for each subject (Day 1 or Day 8 or Day 15) Receives: Drug: AZD3293 oral solution |
| AZD3293 tablet formulation A | Experimental | single doses in random order in 3 study periods for each subject (Day 1 or Day 8 or Day 15) Receives: Drug: AZD3293 tablet formulation A |
| AZD3293 tablet formulation B | Experimental | single doses in random order in 3 study periods for each subject (Day 1 or Day 8 or Day 15) Receives: Drug: AZD3293 tablet formulation B |
What is being measured
The primary outcome is the main question the study is designed to answer.
The relative bioavailability of AZD3293 after administration via 2 tablet formulations compared with oral solution by assessment of the area under the plasma concentration-time curve from zero to infinity for the tablet formulations and the oral solutio
Blood samples for determination of plasma concentrations of AZD3293 and its active metabolite will be collected at pre-dose (15 or 30 min) and 30 min, 1h, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56 and 72 hours post-dose starting on Days 1, 8 \& 15 and analyzed according to fully validated methods.
Measured: up to day 18 (Day 1 - 72 hrs post-dose on Day 15)
To compare the tablet formulations of AZD3293 with the oral solution of AZD3293 by evaluation of the basic pharmacokinetic parameters for each formulation
Blood samples for determination of plasma concentrations of AZD3293 and its active metabolite will be collected at pre-dose (15 or 30 min) and 30 min, 1h, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56 and 72 hours post-dose starting on Days 1, 8 \& 15 and analyzed according to fully validated methods.
Measured: up to day 18 (Day 1 - 72 hrs post-dose on Day 15)
Secondary outcomes (4)
Safety profile in terms of Adverse events assessment
Measured: From Baseline and up to day 25
Safety and tolerability in terms of lab tests assessment (hematology, chemistry, urinalysis)
Measured: From Baseline and up to day 25
Safety and tolerability in terms of vital signs assessment (blood pressure, pulse and body temperature) and physical exams
Measured: From baseline and up to day 25
Safety and tolerability by assessing changes in electrocardiogram (ECG) parameters
Measured: from baseline and up until day 25
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02039180
- Sponsor's protocol ID
- D5010C00005
- Acronym
- BA
- Status last verified
- Apr 2014
- First submitted
- 16 Jan 2014
- Last updated
- 24 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Randomized, Single-dose, 3-period Cross-over, Relative Bioavailability Study to Assess Two Solid Formulations Compared to an Oral Solution of AZD3293 in Healthy Male and Non-Fertile Female Subjects
- ClinicalTrials.gov ID
- NCT02039180
- Acronym / sponsor ID
- BA / D5010C00005
- Conditions
- Healthy Volunteers, Pharmacologic Action
- Keywords
- phase I, healthy volunteers, AZD3293, bioavailability, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 17 Jan 2014 (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.
This is an open-label, randomized, 3-period crossover, single dose study. Three (3) single doses of AZD3293 (2 different tablet formulations, and an oral solution) will be administered with a washout period of at least 1 week between the doses to investigate the relative bioavailability of AZD3293 after administration via 2 tablet formulations compared with oral solution and to evaluate basic systemic pharmacokinetic parameters of the tablet formulations compared to the oral solution of AZD3293.
The safety and tolerability of AZD3293 in healthy subjects will also be assessed in the study. AZD3293 is being developed for the treatment of Alzheimer's disease
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AZD3293 oral solution | Experimental | Drug: AZD3293 oral solutionsingle doses in random order in 3 study periods for each subject (Day 1 or Day 8 or Day 15) |
| AZD3293 tablet formulation A | Experimental | Drug: AZD3293 tablet formulation Asingle doses in random order in 3 study periods for each subject (Day 1 or Day 8 or Day 15) |
| AZD3293 tablet formulation B | Experimental | Drug: AZD3293 tablet formulation Bsingle doses in random order in 3 study periods for each subject (Day 1 or Day 8 or Day 15) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Provision of signed, written, and dated informed consent prior to any study-specific procedures
- Healthy subjects must be able to understand and be willing to comply with study procedures, restrictions, and requirements.
- Male and non-fertile female healthy subjects, aged 18 to 55 years
- Body weight ≥50 to ≤100 kg and body mass index (BMI) ≥19 to ≤30 kg/m2
- Clinically normal findings on physical examination in relation to age, as judged by the Investigator
Key exclusion criteria (3 listed)
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
- History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
- History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder according to the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV), as assessed by the Mini-International Neuropsychiatric Interview (MINI)
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 |
|---|---|---|
| AZD3293 oral solutionAlso: Beta secretase inhibitorSubjects will receive AZD3293 as a tablet (Formulation A; Formulation B) and solution as a single dose on Day 1, Day 8 or Day 15. | Drug | AZD3293 oral solution |
| AZD3293 tablet formulation AAlso: beta secretase inhibitorSubjects will receive AZD3293 as a tablet (Formulation A; Formulation B) and a solution as a single dose on Day 1, Day 8, or Day 15. | Drug | AZD3293 tablet formulation A |
| AZD3293 tablet formulation BAlso: Beta secretase inhibitorSubjects will receive AZD3293 as a tablet (Formulation A; Formulation B) and a solution as a single dose on Day 1, Day 8 or Day 15. | Drug | AZD3293 tablet formulation B |
Primary outcome
The relative bioavailability of AZD3293 after administration via 2 tablet formulations compared with oral solution by assessment of the area under the plasma concentration-time curve from zero to infinity for the tablet formulations and the oral solutio
Time frame: up to day 18 (Day 1 - 72 hrs post-dose on Day 15)
Blood samples for determination of plasma concentrations of AZD3293 and its active metabolite will be collected at pre-dose (15 or 30 min) and 30 min, 1h, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56 and 72 hours post-dose starting on Days 1, 8 \& 15 and analyzed according to fully validated methods.
To compare the tablet formulations of AZD3293 with the oral solution of AZD3293 by evaluation of the basic pharmacokinetic parameters for each formulation
Time frame: up to day 18 (Day 1 - 72 hrs post-dose on Day 15)
Blood samples for determination of plasma concentrations of AZD3293 and its active metabolite will be collected at pre-dose (15 or 30 min) and 30 min, 1h, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56 and 72 hours post-dose starting on Days 1, 8 \& 15 and analyzed according to fully validated methods.
4 secondary outcomes
Safety profile in terms of Adverse events assessment
Time frame: From Baseline and up to day 25
Safety and tolerability in terms of lab tests assessment (hematology, chemistry, urinalysis)
Time frame: From Baseline and up to day 25
Safety and tolerability in terms of vital signs assessment (blood pressure, pulse and body temperature) and physical exams
Time frame: From baseline and up to day 25
Safety and tolerability by assessing changes in electrocardiogram (ECG) parameters
Time frame: from baseline and up until day 25
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 24 Apr 2014.
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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 AZD3293 oral solution, AZD3293 tablet formulation A and AZD3293 tablet formulation B in people with Healthy Volunteers and Pharmacologic Action, run by AstraZeneca at 1 site in United States.
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 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 24 Apr 2014. 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 States. 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?
The relative bioavailability of AZD3293 after administration via 2 tablet formulations compared with oral solution by assessment of the area under the plasma concentration-time curve from zero to infinity for the tablet formulations and the oral solutio (time frame: up to day 18 (Day 1 - 72 hrs post-dose on Day 15)). The study lists 2 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 24 Apr 2014.