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

AstraZeneca30 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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: * 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.

Locations (1)

Research Site

Brooklyn, Maryland, United States