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

Study identifier:D6580C00016

ClinicalTrials.gov identifier:NCT05457270

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

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.

Medical condition

Healthy Volunteers

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD4831

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 11 Aug 2022

Primary Completion Date: 17 Oct 2022

Study Completion Date: 17 Oct 2022

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Oct 2024 by AstraZeneca

Collaborators

PAREXEL

Inclusion and exclusion criteria

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.

No locations available

Arms	Assigned Interventions
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 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.
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 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.

Documents available

redacted CSR Synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]