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

Dyslipidemia Clinical Trial

Official title:

An Open-label, 2-Period, 2-Sequence Cross-over Study to Assess the Effect of AZD0780 on the Pharmacokinetics of Rosuvastatin in Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05787002
• Other study ID #: D7960C00002
• Status: Completed
• Phase: Phase 1
• Start date: March 9, 2023
• Est. completion date: May 15, 2023

Study information

• Verified date: May 2023
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 15, 2023
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

Drug:
• AZD0780
AZD0780 will be administered orally as a single dose after an overnight fast of at least 10 hours with approximately 240 mL of water.
• Rosuvastatin
Rosuvastatin will be administered orally as a single dose after an overnight fast of at least 10 hours with approximately 240 mL of water.

Locations

Country	Name	City	State
United States	Research Site	Brooklyn	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under plasma concentration-time curve from 0 to infinity (AUCinf) of Rosuvastatin	The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose
Primary	Area under the plasma concentration-curve from 0 to the last quantifiable concentration (AUClast) of Rosuvastatin	The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose
Primary	Maximum observed plasma concentration (Cmax) of Rosuvastatin	The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose
Primary	Terminal elimination half-life (t½?z) of Rosuvastatin	The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose
Primary	Time to reach maximum observed concentration (tmax) of Rosuvastatin	The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose
Primary	Apparent total body clearance (CL/F) of Rosuvastatin	The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose
Primary	Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F) of Rosuvastatin	The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose
Primary	Area under plasma concentration-time curve from 0 to infinity (AUCinf) of AZD0780	The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose
Primary	Area under the plasma concentration-curve from 0 to the last quantifiable concentration (AUClast) of AZD0780	The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose
Primary	Maximum observed plasma concentration (Cmax) of AZD0780	The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose
Primary	Time to reach maximum observed concentration (tmax) of AZD0780	The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose
Primary	Terminal elimination half-life (t½?z) of AZD0780	The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose
Primary	Apparent total body clearance (CL/F) of AZD0780	The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose
Primary	Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F) of AZD0780	The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose
Secondary	Number of participants with Adverse Events	The safety and tolerability of AZD0780 in combination with rosuvastatin in healthy participants will be assessed.	From Screening (= 28 days to Day -2) until Follow-up Visit (10 to 12 days post-final dose)