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CompletedNCT05457270Updated Nov 1, 2022

A Study to Assess the Relative Bioavailability and Safety of Different Formulations of AZD4831 in Fasted State in Healthy Volunteers.

A Phase 1 interventional study of AZD4831 in Healthy Volunteers, sponsored by AstraZeneca. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-01.

Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Oct 2022, 3 years 11 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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.
02

Conditions studied

  • Healthy Volunteers

Keywords

  • Relative Bioavailability
  • AZD4831
  • Heart failure with preserved ejection fraction
  • Cardiovascular disease
03

In context

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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:

    1. 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.
    2. 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • Participants who previously received AZD4831.

  • Any of the following signs or confirmation of COVID-19 infection:

    1. 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.
    2. 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.
    3. Participant has been hospitalized with COVID-19 infection within the last 3 months.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Sequence 1 (Formulation A + Formulation B)

    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.

    Drug: AZD4831

  • Experimental
    Sequence 2 (Formulation B + Formulation A)

    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.

    Drug: AZD4831

Interventions

  • DrugAZD4831

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 1, Day 2 to Day 8 and Day 14

  2. 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.

    Time frame: Day 1, Day 2 to Day 8 and Day 14

  3. 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.

    Time frame: Day 1, Day 2 to Day 8 and Day 14

  4. 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.

    Time frame: Day 1, Day 2 to Day 8 and Day 14

  5. 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.

    Time frame: Day 1, Day 2 to Day 8 and Day 14

  6. 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.

    Time frame: Day 1, Day 2 to Day 8 and Day 14

  7. 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.

    Time frame: Day 1, Day 2 to Day 8 and Day 14

  8. 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.

    Time frame: Day 1, Day 2 to Day 8 and Day 14

  9. 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.

    Time frame: 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.

    Time frame: From Screening until Follow up visit (At 14 days post final dose)

07

Study locations

1 site
  • Research Site
    Brooklyn, Maryland 21225, United States
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05457270
Lead sponsor
AstraZeneca
Collaborators
Parexel
Responsible party
Sponsor
First posted
Jul 13, 2022
Start date
Aug 11, 2022
Primary completion
Oct 17, 2022
Completion
Oct 17, 2022
Last update
Nov 1, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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