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OpenTrials
Completed

NCT Number: NCT05787002

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Brooklyn, Maryland, 21225, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Area under plasma concentration-time curve from 0 to infinity (AUCinf) of Rosuvastatin

    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

    The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.

  2. Area under the plasma concentration-curve from 0 to the last quantifiable concentration (AUClast) of Rosuvastatin

    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

    The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.

  3. Maximum observed plasma concentration (Cmax) of Rosuvastatin

    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

    The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.

  4. Terminal elimination half-life (t½λz) of Rosuvastatin

    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

    The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.

  5. Time to reach maximum observed concentration (tmax) of Rosuvastatin

    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

    The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.

  6. Apparent total body clearance (CL/F) of Rosuvastatin

    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

    The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.

  7. Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F) of Rosuvastatin

    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

    The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.

  8. Area under plasma concentration-time curve from 0 to infinity (AUCinf) of AZD0780

    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

    The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.

  9. Area under the plasma concentration-curve from 0 to the last quantifiable concentration (AUClast) of AZD0780

    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

    The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.

  10. Maximum observed plasma concentration (Cmax) of AZD0780

    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

    The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.

  11. Time to reach maximum observed concentration (tmax) of AZD0780

    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

    The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.

  12. Terminal elimination half-life (t½λz) of AZD0780

    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

    The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.

  13. Apparent total body clearance (CL/F) of AZD0780

    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

    The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.

  14. Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F) of AZD0780

    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

    The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.

Secondary outcomes

  1. Number of participants with Adverse Events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 28, 2023
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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