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Completed

NCT Number: NCT05457270

A 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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Brooklyn, Maryland, 21225, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • 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.

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:
  • 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.

Treatment and study plan

AZD4831

Drug

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Secondary outcomes

  1. Number of participants with Adverse Events (AEs)

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

    The safety and tolerability of single doses of AZD4831 in healthy volunteers will be assessed.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Parexel

Registry information

Official study 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.

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 13, 2022
Registry last updated
Nov 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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