NCT05457270

Brief Summary

A study to assess the relative bioavailability and safety of different formulations of AZD4831 in fasted state in healthy volunteers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started Aug 2022

Shorter than P25 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 13, 2022

Completed
29 days until next milestone

Study Start

First participant enrolled

August 11, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2022

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

2 months

First QC Date

July 11, 2022

Last Update Submit

October 31, 2022

Conditions

Healthy Volunteers

Keywords

Relative BioavailabilityAZD4831Heart failure with preserved ejection fractionCardiovascular disease

Outcome Measures

Primary Outcomes (9)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    Day 1, Day 2 to Day 8 and Day 14

Secondary Outcomes (1)

  • Number of participants with Adverse Events (AEs)

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

Study Arms (2)

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.

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.

Drug: AZD4831

Interventions

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.

Sequence 1 (Formulation A + Formulation B)Sequence 2 (Formulation B + Formulation A)

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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:
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Brooklyn, Maryland, 21225, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

AZD4831

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2022

First Posted

July 13, 2022

Study Start

August 11, 2022

Primary Completion

October 17, 2022

Study Completion

October 17, 2022

Last Updated

November 1, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will share

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.

Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Access Criteria
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
More information

Locations

US(1)