DyslipidemiaPhase 1NCT05787002
A Study to Assess the Effect of AZD0780 on the Pharmacokinetics of Rosuvastatin.
A Phase 1 study testing AZD0780 and Rosuvastatin in people with Dyslipidemia, run by AstraZeneca at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- AZD0780 and Rosuvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2023to 15 May 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Dyslipidemia
- Being tested
- AZD0780, Rosuvastatin
- Keywords
- Hypercholesterolemia, elevated Low-density lipoprotein-cholesterol (LDL-C) levels, Drug-drug interaction, Healthy Participants
- Medical subject headings
- Dyslipidemias, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD0780Drug
AZD0780 will be administered orally as a single dose after an overnight fast of at least 10 hours with approximately 240 mL of water.
RosuvastatinDrug
Rosuvastatin will be administered orally as a single dose after an overnight fast of at least 10 hours with approximately 240 mL of water.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: AZD0780; Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
The safety and tolerability of AZD0780 in combination with rosuvastatin in healthy participants will be assessed.
Measured: From Screening (≤ 28 days to Day -2) until Follow-up Visit (10 to 12 days post-final dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start9 Mar 2023
- Primary completion15 May 2023
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05787002
- Sponsor's protocol ID
- D7960C00002
- Status last verified
- Apr 2025
- First submitted
- 23 Feb 2023
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05787002
- Acronym / sponsor ID
- D7960C00002
- Conditions
- Dyslipidemia
- Keywords
- Hypercholesterolemia, elevated Low-density lipoprotein-cholesterol (LDL-C) levels, Drug-drug interaction, Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 28 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment sequence A-B | Experimental | Drug: AZD0780, Drug: RosuvastatinParticipants 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. |
| Treatment sequence B-A | Experimental | Drug: AZD0780, Drug: RosuvastatinParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD0780AZD0780 will be administered orally as a single dose after an overnight fast of at least 10 hours with approximately 240 mL of water. | Drug | Treatment sequence A-B, Treatment sequence B-A |
| RosuvastatinRosuvastatin will be administered orally as a single dose after an overnight fast of at least 10 hours with approximately 240 mL of water. | Drug | Treatment sequence A-B, Treatment sequence B-A |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- CSR Synopsis D7960C00002Link provided by the sponsor.
- Results of this clinical trial are available on www.astrazenecaclinicaltrials.comLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD0780 and Rosuvastatin in people with Dyslipidemia, run by AstraZeneca at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.