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

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

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.

Study Overview

• Status: Completed
• Conditions: Dyslipidemia
• Intervention / Treatment: Drug: AZD0780; Drug: Rosuvastatin

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Brooklyn, Maryland, United States, 21225
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment sequence A-B; 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.	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.; Drug: 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.
Experimental: Treatment sequence B-A; 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.	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.; Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Terminal elimination half-life (t½λz) 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
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
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
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
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
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
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
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
Terminal elimination half-life (t½λz) 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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

Helpful Links

• CSR Synopsis D7960C00002
• Results of this clinical trial are available on www.astrazenecaclinicaltrials.com

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2023
• Primary Completion (Actual): May 15, 2023
• Study Completion (Actual): May 15, 2023

Study Registration Dates

• First Submitted: February 23, 2023
• First Submitted That Met QC Criteria: March 27, 2023
• First Posted (Actual): March 28, 2023

Study Record Updates

• Last Update Posted (Actual): April 27, 2025
• Last Update Submitted That Met QC Criteria: April 25, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Hypercholesterolemia; Healthy Participants; Drug-drug interaction; elevated Low-density lipoprotein-cholesterol (LDL-C) levels
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium
• Other Study ID Numbers: D7960C00002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No