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

Sponsor

AstraZeneca (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05787002

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dyslipidemia	Drug: AZD0780 Drug: Rosuvastatin	Phase 1

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention 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.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)

Primary Purpose:

Other

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

Actual Study Start Date :

Mar 9, 2023

Anticipated Primary Completion Date :

Apr 29, 2023

Anticipated Study Completion Date :

May 9, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Area under plasma concentration-time curve from 0 to infinity (AUCinf) of Rosuvastatin [Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose]
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 [Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose]
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
Maximum observed plasma concentration (Cmax) of Rosuvastatin [Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose]
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
Terminal elimination half-life (t½λz) of Rosuvastatin [Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose]
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
Time to reach maximum observed concentration (tmax) of Rosuvastatin [Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose]
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
Apparent total body clearance (CL/F) of Rosuvastatin [Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose]
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 [Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose]
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 [Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose]
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 [Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose]
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
Maximum observed plasma concentration (Cmax) of AZD0780 [Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose]
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
Time to reach maximum observed concentration (tmax) of AZD0780 [Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose]
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
Terminal elimination half-life (t½λz) of AZD0780 [Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose]
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
Apparent total body clearance (CL/F) of AZD0780 [Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose]
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 [Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose]
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.

Secondary Outcome Measures

Number of participants with Adverse Events [From Screening (≤ 28 days to Day -2) until Follow-up Visit (10 to 12 days post-final dose)]
The safety and tolerability of AZD0780 in combination with rosuvastatin in healthy participants will be assessed.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Brooklyn	Maryland	United States	21225

Sponsors and Collaborators

AstraZeneca

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT05787002

Other Study ID Numbers:

D7960C00002

First Posted:

Mar 28, 2023

Last Update Posted:

Mar 28, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by AstraZeneca

Hypercholesterolemia

elevated Low-density lipoprotein-cholesterol (LDL-C) levels

Drug-drug interaction

Healthy Participants

Additional relevant MeSH terms:

Dyslipidemias

Rosuvastatin Calcium

Study Results

No Results Posted as of Mar 28, 2023