A Bioavailability and Food Effect Study of AZD5462 in Healthy Volunteers

NCT05512806 | Completed Phase 1 FDA Drug

• 1 other identifier: D9090C00005
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess the pharmacokinetics of AZD5462 film-coated tablet formulation in healthy participants.

Conditions

Healthy Participants

Keywords

Healthy participants; Food effect; Relative bioavailability

Outcome Measures

Primary Outcomes (9)

• Area under plasma concentration time curve from zero to infinity (AUCinf)

  The AUCinf of a film-coated tablet of AZD5462 at 3 dose levels will be assessed.

  Day 1 to Day 17

• Area under the plasma concentration-curve from time zero to last quantifiable concentration (AUClast)

  The AUClast of a film-coated tablet of AZD5462 at 3 dose levels will be assessed.

  Day 1 to Day 17

• Maximum observed plasma (peak) drug concentration [Cmax]

  The Cmax of a film-coated tablet of AZD5462 at 3 dose levels will be assessed.

  Day 1 to Day 17

• Area under plasma concentration time curve from zero to infinity (AUCinf)

  The effect of a high-fat, high-calorie meal in comparison to fasting conditions on the AUCinf of AZD5462 after a single oral dose at 2 dose levels will be assessed.

  Day 1 to Day 17

• Area under the plasma concentration-curve from time zero to last quantifiable concentration (AUClast)

  The effect of a high-fat, high-calorie meal in comparison to fasting conditions on the AUClast of AZD5462 after a single oral dose at 2 dose levels will be assessed.

  Day 1 to Day 17

• Maximum observed plasma (peak) drug concentration [Cmax]

  The effect of a high-fat, high-calorie meal in comparison to fasting conditions on the Cmax of AZD5462 after a single oral dose at 2 dose levels will be assessed.

  Day 1 to Day 17

• Area under plasma concentration time curve from zero to infinity (AUCinf)

  The relative bioavailability of the film-coated tablet vs oral solution formulation will be determined by the assessment of AUCinf.

  Day 1 to Day 17

• Area under the plasma concentration-curve from time zero to last quantifiable concentration (AUClast)

  The relative bioavailability of the film-coated tablet vs oral solution formulation will be determined by the assessment of AUClast.

  Day 1 to Day 17

• Maximum observed plasma (peak) drug concentration [Cmax]

  The relative bioavailability of the film-coated tablet vs oral solution formulation will be determined by the assessment of Cmax.

  Day 1 to Day 17

Secondary Outcomes (1)

• Number of participants with Adverse Events (AEs), and Serious Adverse Events (SAEs)

  Until follow-up (Day 21)

Study Arms (6)

Treatment A

EXPERIMENTAL

Participants will receive Dose A orally as a film-coated tablet.

Drug: AZD5462

Treatment B

EXPERIMENTAL

Participants will receive Dose A orally as a film-coated tablet.

Drug: AZD5462

Treatment C

EXPERIMENTAL

Participants will receive Dose B orally as a film-coated tablet.

Drug: AZD5462

Treatment D

EXPERIMENTAL

Participants will receive Dose B orally as an oral solution.

Drug: AZD5462

Treatment E

EXPERIMENTAL

Participants will receive Dose C orally as a film-coated tablet.

Drug: AZD5462

Treatment F

EXPERIMENTAL

Participants will receive Dose C orally as a film-coated tablet.

Drug: AZD5462

Interventions

AZD5462 DRUG

Participants will receive AZD5462 orally.

Treatment A; Treatment B; Treatment C; Treatment D; Treatment E; Treatment F

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Provision of signed and dated, written informed consent prior to any study specific procedures.
• Healthy male and female participants aged 18 to 55 years at screening and admission with suitable veins for cannulation or repeated venipuncture.
• Females must have a negative pregnancy test at screening and on admission to the study center, 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)/Luteinizing hormone (LH) levels in the postmenopausal range.
• Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.
• Male participant must adhere to the contraception methods details.
• Have a Body mass index (BMI) between 18 and 32 kg/m2 inclusive and weigh at least 50 kg and no more than 105 kg inclusive at screening.

You may not qualify if:

• History of any clinically significant disease or disorder which may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
• Any of the below conditions:
• Systemic sclerosis.
• Moderate to severe valvular disease.
• Hypertrophic obstructive cardiomyopathy.
• Restrictive cardiomyopathy.
• Gilbert's syndrome.
• History of vascular or left ventricular aneurysms, or prior dissections.
• Any history of joint hypermobility, Marfan's Syndrome, or any connective tissue disorder.
• History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
• Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of Investigational medicinal product (IMP).
• Any laboratory values with the following deviations at screening, or admission to the study center:
• Total bilirubin \> Upper limit of normal (ULN).
• Alanine aminotransferase \> 1.5 × ULN.
• Aspartate aminotransferase \> 1.5 × ULN.

Sponsors & Collaborators

• AstraZeneca: lead
• Parexel: collaborator

Study Sites (1)

Research Site

Brooklyn, Maryland, 21225, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study due to which blinding is not applicable.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 23, 2022
• Study Start: August 24, 2022
• Primary Completion: November 7, 2022
• Study Completion: November 7, 2022
• Last Updated: November 9, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• 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 rerefer 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 de-identified 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.

Locations

US (1)