Study to Assess the Effect of AZD4831 on the Pharmacokinetics (Drug Behavior in the Body) of Midazolam

NCT ID: NCT05052710

Last Updated: 2021-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-05
• Study Completion Date: 2021-11-29

Brief Summary

The study is an open-label, fixed-sequence, cross-over study conducted at a single Clinical Unit to assess the pharmacokinetics (PK) of midazolam in healthy male and female (non-childbearing potential) subjects when administered alone and in combination with AZD4831 after multiple doses (once daily) of AZD4831 for 10 consecutive days.

Detailed Description

The study will consist of 2 treatment periods and will comprise:

• A Screening period of maximum 28 days;
• Treatment Period 1 and Treatment Period 2:

Treatment Period 1: Midazolam only (Day 1). Treatment Period 2: AZD4831 only (Days 2 to 10, once daily dosing) and AZD4831 plus midazolam (Day 11).

• A final Follow-up Visit after the last administration of investigational medicinal product (IMP) (Day 20 [± 1 day]).

Each subject will be involved in the study for approximately 7 weeks.

Conditions

Healthy Volunteers

Keywords

Cardiovascular Disease; Drug-drug interaction; Pharmacokinetics; Myeloperoxidase inhibitor; Fixed-sequence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Arm

Subjects will receive midazolam on Day 1 and AZD4831 once daily from Days 2 to 10, and AZD4831 plus midazolam on Day 11.

Group Type: EXPERIMENTAL

AZD4831

Intervention Type: DRUG

Subjects will receive oral doses once daily from Days 2-11.

Midazolam

Intervention Type: DRUG

Subjects will receive oral single doses on Day 1 and Day 11.

Interventions

AZD4831

Subjects will receive oral doses once daily from Days 2-11.

Intervention Type: DRUG

Midazolam

Subjects will receive oral single doses on Day 1 and Day 11.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy male and/or female subjects with suitable veins for cannulation or repeated venepuncture.
• Males must be willing to use appropriate contraception methods.
• Females must not be lactating and must be of non-childbearing potential, confirmed at Screening.
• Have a body mass index between 18.5 and 30 kg/m^2 (inclusive) and weigh at least 50 kg and no more than 100 kg (inclusive) at Screening.

Exclusion Criteria

• History of any clinically significant disease or 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.
• A positive Corona Virus Disease 2019 test at Screening or admission to the Clinical Unit on Day -1.
• Any clinically significant abnormalities in clinical chemistry, haematology, or urinalysis results.
• Any clinically significant abnormal findings in vital signs.
• clinically significant abnormalities on 12-lead electrocardiogram.
• Any positive result at the Screening Visit for Hepatitis B surface antigen, hepatitis C virus antibody, and human immunodeficiency virus antibody.
• Known or suspected history of drug abuse in the last 2 years.
• Current smokers or those who have smoked or used nicotine products within the 3 months prior to the Screening Visit.
• Known or suspected history of alcohol or drug abuse.
• Use of any prescribed or non-prescribed medication.
• Subjects with acute pulmonary insufficiency, marked neuromuscular respiratory weakness, obsessional states, phobic states, sleep apnoea syndrome, or unstable myasthenia gravis.
• History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigatoror history of hypersensitivity to drugs with a similar chemical structure or class to AZD4831 or midazolam.
• History or ongoing allergy/hypersensitivity to drugs(including but not limited to rash, angioedema, acute urticaria).
• Subjects who, in the opinion of the Investigator, have any clinically significant skin condition.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research Site

Harrow, , United Kingdom

Countries

United Kingdom

Other Identifiers

D6580C00012

Identifier Type: -

Identifier Source: org_study_id