A Study to Investigate the Pharmacokinetics of AZD2389 in Healthy Participants When Administered Alone and in Combination With Quinidine

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy Participants; Advanced Chronic Liver Disease

Treatments: Drug: Quinidine; Drug: AZD2389

Study type: Interventional

Funder types: Industry

Identifiers

NCT06974565

D7930C00006

Details and patient eligibility

About

The purpose of this study is to assess the pharmacokinetics (PK) and safety of AZD2389 when administered alone and in combination with quinidine in healthy participants.

Full description

This is a 2-way cross-over study to evaluate the effect of quinidine on the PK of AZD2389.

The study will include 2 Treatments - Treatment A - AZD2389 Treatment B - AZD2389 + quinidine

The study will comprise -

1. A Screening Period of maximum 28 days.
2. Period 1: single dose administration of Treatment A or Treatment B on Day 1. Period 2 will start after a washout period of at least 7 days.
3. Period 2: single dose of alternate treatment on Day 8.
4. A Follow-up Visit: participants will return for a Follow-up Visit, 7 to 14 days after the last AZD2389 PK sample in Period 2.

Participants will be randomized to one of the 2 treatment sequences -

1. Sequence AB: Treatment A in Period 1, Treatment B in Period 2.
2. Sequence BA: Treatment B in Period 1, Treatment A in Period 2.

Enrollment: 16 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and female (of non-childbearing potential) participants with suitable veins for cannulation or repeated venipuncture.
• All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
• Females of non-childbearing potential must be confirmed at the Screening Visit.
• Sexually active fertile male participants with partners of childbearing potential must adhere to the study specific contraception methods from the time of first administration of study intervention administration until 3 months after the study Follow-up Visit.
• Have a body mass index between 18 and 32 kg/m2, inclusive, and weigh at least 50 kg at the Screening Visit.

Exclusion criteria

• History of any clinically important 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.
• Any clinically important abnormalities in hematology, clinical chemistry, urinalysis, coagulation results or other laboratory values and vital signs.
• Any positive result on Screening for serum hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus antibody (HCV Ab), or human immunodeficiency virus (HIV).
• Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12-lead electrocardiogram (ECG) at Screening.
• Known or suspected history of alcohol or drug abuse or excessive intake of alcohol.
• Current smokers or those who have smoked or used nicotine products within the previous 3 months prior to screening.
• Positive screen for drugs of abuse, or alcohol or cotinine at Screening.
• History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity.
• History of hypersensitivity to dipeptidyl peptidase 4 (DPP4) inhibitors.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Sequence AB

Experimental group

Description:

Participants will receive a single dose of Treatment A (AZD2389) in Period 1 and a single dose of Treatment B (AZD2389 + quinidine) in Period 2.

Treatment:

Drug: AZD2389

Drug: Quinidine

Sequence BA

Experimental group

Description:

Participants will receive a single dose of Treatment B (AZD2389 + quinidine) in Period 1 and a single dose of Treatment A (AZD2389) in Period 2.

Treatment:

Drug: AZD2389

Drug: Quinidine