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

• Status: Recruiting
• Trial end date: 2021-11-26
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AstraZeneca
• Treatments: Midazolam

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.