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

NCT05787002 | Completed Phase 1 FDA Drug

• 1 other identifier: D7960C00002
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dyslipidemia

Keywords

Hypercholesterolemia; elevated Low-density lipoprotein-cholesterol (LDL-C) levels; Drug-drug interaction; Healthy Participants

Outcome Measures

Primary Outcomes (14)

• 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 Outcomes (1)

• Number of participants with Adverse Events

  From Screening (≤ 28 days to Day -2) until Follow-up Visit (10 to 12 days post-final dose)

Study Arms (2)

Treatment sequence A-B

EXPERIMENTAL

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; Drug: Rosuvastatin

Treatment sequence B-A

EXPERIMENTAL

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; Drug: Rosuvastatin

Interventions

AZD0780 DRUG

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

Treatment sequence A-B; Treatment sequence B-A

Rosuvastatin DRUG

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

Treatment sequence A-B; Treatment sequence B-A

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Brooklyn, Maryland, 21225, United States

Location

Related Links

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

MeSH Terms

Conditions

Dyslipidemias; Hypercholesterolemia

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperlipidemias

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be randomized, in a 1:1 ratio into each of the treatment arms prior to the study commencing. Each participant will receive 2 treatments in total throughout the study.

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 28, 2023
• Study Start: March 9, 2023
• Primary Completion: May 15, 2023
• Study Completion: May 15, 2023
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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.
• 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.

Locations

US (1)