A Study to Assess the Effect of AZD0780 on the Pharmacokinetics of Rosuvastatin.

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Dyslipidemia

Treatments: Drug: Rosuvastatin; Drug: AZD0780

Study type: Interventional

Funder types: Industry

Identifiers

NCT05787002

D7960C00002

Details and patient eligibility

About

The purpose of the study is to assess the effect of AZD0780 on the pharmacokinetics of rosuvastatin, and to assess the safety and tolerability of AZD0780 single dose, in healthy participants administered alone and in combination with rosuvastatin.

Full description

Eligible participants will be randomized, in a 1:1 ratio into 2 of the treatment arms. Each participant will receive 2 treatments in total throughout the study. The following treatments will be given in randomized order in fasting state:

Treatment A: single dose of rosuvastatin tablet alone

Treatment B: single dose of rosuvastatin tablet + AZD0780 tablet

The study will comprise:

1. A Screening Period of maximum 28 days.
2. Two Treatment Periods up to 3 days
3. A follow-up period of 10 to 12 days after the last administration of the study drug.

Following an overnight fast (minimum 10 hours) participants will receive either of the two treatments and will remain resident in the Clinical Unit until up to 48 hours after dosing of the study drug (up to Day 3).

The total duration of the study will be up to 9 weeks.

Enrollment: 16 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Provision of signed and dated, written informed consent prior to any study specific procedures.
• Healthy male and female participants (of non-childbearing potential) aged 18 to 60 years, inclusive, with suitable veins for cannulation or repeated venipuncture.
• Females must have a negative pregnancy test at screening and must not be lactating
• Participants with BMI between 18 and 30 kg/m^2, inclusive, and weighing between 50 kg and 100 kg, inclusive

Exclusion criteria

• History or presence of gastrointestinal, hepatic or renal disease, or any other clinically significant disease or disorder
• Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, or HIV.
• Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) first vaccination within 30 days prior to randomization and second vaccination within 10 days of screening
• Confirmed Coronavirus disease 2019 (COVID-19) infection at admission, by Polymerase chain reaction (PCR) test
• Plasma donation within 1 month of screening or any blood donation/loss more than 500 mL during the 3 months prior to screening
• History or presence of severe allergy/hypersensitivity
• Current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the 3 months prior to screening
• Positive screen for drugs of abuse, alcohol, or cotinine at screening
• Use of drugs with enzyme-inducing properties such as St John's Wort within 3 weeks prior to the first administration of the study drug
• Any clinically significant abnormalities in clinical chemistry, hematology, coagulation, urinalysis results, ECG or vital signs

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Treatment sequence A-B

Experimental group

Description:

Participants will receive treatments in the following sequence, a single dose of rosuvastatin tablet alone (Treatment A) in period 1, and then a single dose of rosuvastatin tablet + Dose X AZD0780 tablet (Treatment B) in period 2.

Treatment:

Drug: AZD0780

Drug: Rosuvastatin

Treatment sequence B-A

Experimental group

Description:

Participants will receive 1 treatment during each study period in the following sequence: a single dose of rosuvastatin tablet + AZD0780 tablet (Treatment B) in period 1 and then a single dose of rosuvastatin tablet alone (Treatment A) in period 2.

Treatment:

Drug: AZD0780

Drug: Rosuvastatin