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

AstraZeneca

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: AZD4831

Drug: Midazolam

Study type

Interventional

Funder types

Industry

Identifiers

NCT05052710

D6580C00012

Details and patient eligibility

About

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.

Full 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.

Enrollment

14 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.