Healthy VolunteersPhase 1NCT05457270
A Study to Assess the Relative Bioavailability and Safety of Different Formulations of AZD4831 in Fasted State in Healthy Volunteers.
A Phase 1 study testing AZD4831 in people with Healthy Volunteers, run by AstraZeneca at 1 site in United States.
Trial summary
A study to assess the relative bioavailability and safety of different formulations of AZD4831 in fasted state in healthy volunteers. 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
- What is being tested?
- AZD4831
- 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 siteUnited States
- Study dates
- 11 Aug 2022to 17 Oct 2022
- 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 and dated, written informed consent prior to any study-specific procedures.
- Male participants must adhere to the contraception methods.
- Females must have a negative pregnancy test at screening and on admission to the Clinical Unit, must not be lactating and must be of non-childbearing potential, confirmed at screening by fulfilling one of the following criteria:
- Postmenopausal defined as amenorrhea for at least 12 months or more following cessation of all exogenous hormonal treatments and Follicle-stimulating hormone (FSH) levels in the postmenopausal range.
- Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.
- Have a Body mass index (BMI) between 18.5 and 30 kg/m2 (inclusive) and weigh at least 50 kg and no more than 100 kg inclusive at Screening.
Who cannot join
- Any clinically significant abnormalities on 12-lead Electrocardiogram (ECG) at the Screening Visit, as judged by the Investigator.
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IMP.
- History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Known or suspected Gilbert's syndrome.
- History or ongoing allergy/hypersensitivity to drugs (including, but not limited to rash, angioedema, acute urticaria).
- Use of drugs with enzyme-inducing properties such as St John's Wort within 3 weeks before the first administration of AZD4831.
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- Participants who previously received AZD4831.
- Any of the following signs or confirmation of COVID-19 infection:
- Participant has a positive SARS-CoV-2 reverse transcription-PCR test result within 2 weeks before the Screening Visit or between the Screening Visit and Randomization.
- Clinical signs and symptoms consistent with COVID-19 (eg, fever, dry cough, dyspnea, sore throat, fatigue) 2 weeks before the Screening Visit or between the Screening Visit and Randomization.
- Participant has been hospitalized with COVID-19 infection within the last 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Single-dose, Open-label, Single-center, Crossover Study to Assess the Relative Bioavailability and Safety of Different Formulations of AZD4831 in Fasted State in Healthy Volunteers.
A study to assess the relative bioavailability and safety of different formulations of AZD4831 in fasted state in healthy volunteers.
Read the detailed description
This study will be a randomized, open-label, 2-period, 2-treatment, single-dose, single-center, crossover study conducted at a single Clinical Unit. A total of 30 healthy male and female participants will be randomized to ensure that at least 26 participants are evaluable .
The study will comprise of:
- A Screening Period of maximum 28 days.
- Period 1: single oral dose AZD4831 Formulation A or B on Day 1.
- Period 2: single oral dose AZD4831 Formulation A or B on Day 1.
- A final Follow-up Visit after the last administration of Investigational medicinal product (IMP) (14 days [+ 3 days] post final dose).
There will be a minimum washout period of at least 14 days from the first dose of AZD4831.
Participants will receive single doses of AZD4831 (2 different formulations) on 2 occasions under fasted conditions.
Participants will be given the following treatments and randomly assigned to the treatment sequence(s): AB, BA
- Treatment 1 (Reference), AZD4831 Formulation A, oral dosage form), fasted.
- Treatment 2 (Test), AZD4831 Formulation B, oral dosage from), fasted.
- Conditions
- Healthy Volunteers
- Being tested
- AZD4831
- Keywords
- Relative Bioavailability, AZD4831, Heart failure with preserved ejection fraction, Cardiovascular disease
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD4831Drug
Participants will receive a single oral dose of AZD4831 Formulation A Or a single oral dose of AZD4831 Formulation B on Day 1 Period 1. Depending on what Formulation was received on Day 1 Period 1, participants will receive either a single oral dose of AZD4831 Formulation A Or a single oral dose of AZD4831 Formulation B on Day 1 of Period 2. Each period lasts for 8 days.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 (Formulation A + Formulation B) | Experimental | Participants will receive a single oral dose of Treatment 1: Formulation A followed by a washout period of at least 14 days from first dose of AZD4831. After the washout period, participants will receive a single oral dose of Treatment 2: AZD4831 Formulation B. Receives: Drug: AZD4831 |
| Sequence 2 (Formulation B + Formulation A) | Experimental | Participants will receive a single oral dose of Treatment 2: Formulation B followed by a washout period of at least 14 days from first dose of AZD4831. After the washout period, participants will receive a single oral dose of Treatment 1 Formulation A. Receives: Drug: AZD4831 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative bioavailability (Frel)
The relative bioavailability of a new AZD4831 formulation compared to the formulation used in an ongoing Phase 2b study and in a couple Phase 1 studies in healthy volunteers will be evaluated.
Measured: Day 1, Day 2 to Day 8 and Day 14
Maximum observed plasma (peak) drug concentration (Cmax)
The relative bioavailability of a new AZD4831 formulation compared to the formulation used in an ongoing Phase 2b study and in a couple Phase 1 studies in healthy volunteers will be evaluated.
Measured: Day 1, Day 2 to Day 8 and Day 14
Area under the plasma concentration-curve from zero to the last quantifiable concentration (AUClast)
The relative bioavailability of a new AZD4831 formulation compared to the formulation used in an ongoing Phase 2b study and in a couple Phase 1 studies in healthy volunteers will be evaluated.
Measured: Day 1, Day 2 to Day 8 and Day 14
Area under plasma concentration-time curve from zero to infinity (AUCinf)
The relative bioavailability of a new AZD4831 formulation compared to the formulation used in an ongoing Phase 2b study and in a couple Phase 1 studies in healthy volunteers will be evaluated.
Measured: Day 1, Day 2 to Day 8 and Day 14
Terminal rate constant, estimated by log-linear least squares regression of the terminal part of the concentration-time curve (λz)
The relative bioavailability of a new AZD4831 formulation compared to the formulation used in an ongoing Phase 2b study and in a couple Phase 1 studies in healthy volunteers will be evaluated.
Measured: Day 1, Day 2 to Day 8 and Day 14
Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2λz)
The relative bioavailability of a new AZD4831 formulation compared to the formulation used in an ongoing Phase 2b study and in a couple Phase 1 studies in healthy volunteers will be evaluated.
Measured: Day 1, Day 2 to Day 8 and Day 14
Time of last observed (quantifiable) concentration (tlast)
The relative bioavailability of a new AZD4831 formulation compared to the formulation used in an ongoing Phase 2b study and in a couple Phase 1 studies in healthy volunteers will be evaluated.
Measured: Day 1, Day 2 to Day 8 and Day 14
Last observed (quantifiable) concentration (Clast)
The relative bioavailability of a new AZD4831 formulation compared to the formulation used in an ongoing Phase 2b study and in a couple Phase 1 studies in healthy volunteers will be evaluated.
Measured: Day 1, Day 2 to Day 8 and Day 14
Time to reach peak or maximum observed concentration or response following drug administration (tmax)
The relative bioavailability of a new AZD4831 formulation compared to the formulation used in an ongoing Phase 2b study and in a couple Phase 1 studies in healthy volunteers will be evaluated.
Measured: Day 1, Day 2 to Day 8 and Day 14
Secondary outcomes (1)
Number of participants with Adverse Events (AEs)
The safety and tolerability of single doses of AZD4831 in healthy volunteers will be assessed.
Measured: From Screening until Follow up visit (At 14 days post final dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start11 Aug 2022
- Primary completion17 Oct 2022
- Study completion17 Oct 2022
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05457270
- Sponsor's protocol ID
- D6580C00016
- Status last verified
- Oct 2022
- First submitted
- 11 Jul 2022
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-dose, Open-label, Single-center, Crossover Study to Assess the Relative Bioavailability and Safety of Different Formulations of AZD4831 in Fasted State in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT05457270
- Acronym / sponsor ID
- D6580C00016
- Conditions
- Healthy Volunteers
- Keywords
- Relative Bioavailability, AZD4831, Heart failure with preserved ejection fraction, Cardiovascular disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 11 Aug 2022 (actual)
- Primary completion
- 17 Oct 2022 (actual)
- Study completion
- 17 Oct 2022 (actual)
- First posted
- 13 Jul 2022 (actual)
- 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 assess the relative bioavailability and safety of different formulations of AZD4831 in fasted state in healthy volunteers.
Detailed description
This study will be a randomized, open-label, 2-period, 2-treatment, single-dose, single-center, crossover study conducted at a single Clinical Unit. A total of 30 healthy male and female participants will be randomized to ensure that at least 26 participants are evaluable .
The study will comprise of:
- A Screening Period of maximum 28 days.
- Period 1: single oral dose AZD4831 Formulation A or B on Day 1.
- Period 2: single oral dose AZD4831 Formulation A or B on Day 1.
- A final Follow-up Visit after the last administration of Investigational medicinal product (IMP) (14 days [+ 3 days] post final dose).
There will be a minimum washout period of at least 14 days from the first dose of AZD4831.
Participants will receive single doses of AZD4831 (2 different formulations) on 2 occasions under fasted conditions.
Participants will be given the following treatments and randomly assigned to the treatment sequence(s): AB, BA
- Treatment 1 (Reference), AZD4831 Formulation A, oral dosage form), fasted.
- Treatment 2 (Test), AZD4831 Formulation B, oral dosage from), fasted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 (Formulation A + Formulation B) | Experimental | Drug: AZD4831Participants will receive a single oral dose of Treatment 1: Formulation A followed by a washout period of at least 14 days from first dose of AZD4831. After the washout period, participants will receive a single oral dose of Treatment 2: AZD4831 Formulation B. |
| Sequence 2 (Formulation B + Formulation A) | Experimental | Drug: AZD4831Participants will receive a single oral dose of Treatment 2: Formulation B followed by a washout period of at least 14 days from first dose of AZD4831. After the washout period, participants will receive a single oral dose of Treatment 1 Formulation A. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Provision of signed and dated, written informed consent prior to any study-specific procedures.
- Male participants must adhere to the contraception methods.
- Females must have a negative pregnancy test at screening and on admission to the Clinical Unit, must not be lactating and must be of non-childbearing potential, confirmed at screening by fulfilling one of the following criteria:
- Have a Body mass index (BMI) between 18.5 and 30 kg/m2 (inclusive) and weigh at least 50 kg and no more than 100 kg inclusive at Screening.
Key exclusion criteria (11 listed)
- Any clinically significant abnormalities on 12-lead Electrocardiogram (ECG) at the Screening Visit, as judged by the Investigator.
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IMP.
- History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Known or suspected Gilbert's syndrome.
- History or ongoing allergy/hypersensitivity to drugs (including, but not limited to rash, angioedema, acute urticaria).
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 |
|---|---|---|
| AZD4831Participants will receive a single oral dose of AZD4831 Formulation A Or a single oral dose of AZD4831 Formulation B on Day 1 Period 1. Depending on what Formulation was received on Day 1 Period 1, participants will receive either a single oral dose of AZD4831 Formulation A Or a single oral dose of AZD4831 Formulation B on Day 1 of Period 2. Each period lasts for 8 days. | Drug | Sequence 1 (Formulation A + Formulation B), Sequence 2 (Formulation B + Formulation A) |
Primary outcome
Relative bioavailability (Frel)
Time frame: Day 1, Day 2 to Day 8 and Day 14
The relative bioavailability of a new AZD4831 formulation compared to the formulation used in an ongoing Phase 2b study and in a couple Phase 1 studies in healthy volunteers will be evaluated.
Maximum observed plasma (peak) drug concentration (Cmax)
Time frame: Day 1, Day 2 to Day 8 and Day 14
The relative bioavailability of a new AZD4831 formulation compared to the formulation used in an ongoing Phase 2b study and in a couple Phase 1 studies in healthy volunteers will be evaluated.
Area under the plasma concentration-curve from zero to the last quantifiable concentration (AUClast)
Time frame: Day 1, Day 2 to Day 8 and Day 14
The relative bioavailability of a new AZD4831 formulation compared to the formulation used in an ongoing Phase 2b study and in a couple Phase 1 studies in healthy volunteers will be evaluated.
Area under plasma concentration-time curve from zero to infinity (AUCinf)
Time frame: Day 1, Day 2 to Day 8 and Day 14
The relative bioavailability of a new AZD4831 formulation compared to the formulation used in an ongoing Phase 2b study and in a couple Phase 1 studies in healthy volunteers will be evaluated.
Terminal rate constant, estimated by log-linear least squares regression of the terminal part of the concentration-time curve (λz)
Time frame: Day 1, Day 2 to Day 8 and Day 14
The relative bioavailability of a new AZD4831 formulation compared to the formulation used in an ongoing Phase 2b study and in a couple Phase 1 studies in healthy volunteers will be evaluated.
Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2λz)
Time frame: Day 1, Day 2 to Day 8 and Day 14
The relative bioavailability of a new AZD4831 formulation compared to the formulation used in an ongoing Phase 2b study and in a couple Phase 1 studies in healthy volunteers will be evaluated.
Time of last observed (quantifiable) concentration (tlast)
Time frame: Day 1, Day 2 to Day 8 and Day 14
The relative bioavailability of a new AZD4831 formulation compared to the formulation used in an ongoing Phase 2b study and in a couple Phase 1 studies in healthy volunteers will be evaluated.
Last observed (quantifiable) concentration (Clast)
Time frame: Day 1, Day 2 to Day 8 and Day 14
The relative bioavailability of a new AZD4831 formulation compared to the formulation used in an ongoing Phase 2b study and in a couple Phase 1 studies in healthy volunteers will be evaluated.
Time to reach peak or maximum observed concentration or response following drug administration (tmax)
Time frame: Day 1, Day 2 to Day 8 and Day 14
The relative bioavailability of a new AZD4831 formulation compared to the formulation used in an ongoing Phase 2b study and in a couple Phase 1 studies in healthy volunteers will be evaluated.
1 secondary outcome
Number of participants with Adverse Events (AEs)
Time frame: From Screening until Follow up visit (At 14 days post final dose)
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 1 Nov 2022.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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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 AZD4831 in people with Healthy Volunteers, 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 6 inclusion and 11 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 1 Nov 2022. 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?
Relative bioavailability (Frel) (time frame: Day 1, Day 2 to Day 8 and Day 14). The study lists 9 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 1 Nov 2022; AzTrials last refreshed its copy on 6 Nov 2026.