search
Back to results

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

Primary Purpose

Dyslipidemia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AZD0780
Rosuvastatin
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Dyslipidemia focused on measuring Hypercholesterolemia, elevated Low-density lipoprotein-cholesterol (LDL-C) levels, Drug-drug interaction, Healthy Participants

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts 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

Sites / Locations

  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Treatment sequence A-B

Treatment sequence B-A

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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.
Maximum observed plasma concentration (Cmax) of Rosuvastatin
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
Terminal elimination half-life (t½λz) of Rosuvastatin
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
Time to reach maximum observed concentration (tmax) of Rosuvastatin
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
Apparent total body clearance (CL/F) of Rosuvastatin
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
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.
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.
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.
Maximum observed plasma concentration (Cmax) of AZD0780
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
Time to reach maximum observed concentration (tmax) of AZD0780
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
Terminal elimination half-life (t½λz) of AZD0780
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
Apparent total body clearance (CL/F) of AZD0780
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
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.

Secondary Outcome Measures

Number of participants with Adverse Events
The safety and tolerability of AZD0780 in combination with rosuvastatin in healthy participants will be assessed.

Full Information

First Posted
February 23, 2023
Last Updated
May 30, 2023
Sponsor
AstraZeneca
search

1. Study Identification

Unique Protocol Identification Number
NCT05787002
Brief Title
A Study to Assess the Effect of AZD0780 on the Pharmacokinetics of Rosuvastatin.
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 9, 2023 (Actual)
Primary Completion Date
May 15, 2023 (Actual)
Study Completion Date
May 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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: A Screening Period of maximum 28 days. Two Treatment Periods up to 3 days 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia
Keywords
Hypercholesterolemia, elevated Low-density lipoprotein-cholesterol (LDL-C) levels, Drug-drug interaction, Healthy Participants

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment sequence A-B
Arm Type
Experimental
Arm 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.
Arm Title
Treatment sequence B-A
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
AZD0780
Intervention Description
AZD0780 will be administered orally as a single dose after an overnight fast of at least 10 hours with approximately 240 mL of water.
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Intervention Description
Rosuvastatin will be administered orally as a single dose after an overnight fast of at least 10 hours with approximately 240 mL of water.
Primary Outcome Measure Information:
Title
Area under plasma concentration-time curve from 0 to infinity (AUCinf) of Rosuvastatin
Description
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
Time Frame
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose
Title
Area under the plasma concentration-curve from 0 to the last quantifiable concentration (AUClast) of Rosuvastatin
Description
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
Time Frame
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose
Title
Maximum observed plasma concentration (Cmax) of Rosuvastatin
Description
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
Time Frame
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose
Title
Terminal elimination half-life (t½λz) of Rosuvastatin
Description
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
Time Frame
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose
Title
Time to reach maximum observed concentration (tmax) of Rosuvastatin
Description
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
Time Frame
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose
Title
Apparent total body clearance (CL/F) of Rosuvastatin
Description
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
Time Frame
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose
Title
Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F) of Rosuvastatin
Description
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
Time Frame
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose
Title
Area under plasma concentration-time curve from 0 to infinity (AUCinf) of AZD0780
Description
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
Time Frame
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose
Title
Area under the plasma concentration-curve from 0 to the last quantifiable concentration (AUClast) of AZD0780
Description
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
Time Frame
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose
Title
Maximum observed plasma concentration (Cmax) of AZD0780
Description
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
Time Frame
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose
Title
Time to reach maximum observed concentration (tmax) of AZD0780
Description
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
Time Frame
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose
Title
Terminal elimination half-life (t½λz) of AZD0780
Description
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
Time Frame
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose
Title
Apparent total body clearance (CL/F) of AZD0780
Description
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
Time Frame
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose
Title
Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F) of AZD0780
Description
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
Time Frame
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 Measure Information:
Title
Number of participants with Adverse Events
Description
The safety and tolerability of AZD0780 in combination with rosuvastatin in healthy participants will be assessed.
Time Frame
From Screening (≤ 28 days to Day -2) until Follow-up Visit (10 to 12 days post-final dose)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Research Site
City
Brooklyn
State/Province
Maryland
ZIP/Postal Code
21225
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home

Learn more about this trial

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

We'll reach out to this number within 24 hrs