DyslipidaemiaPhase 1NCT06671405
An Open-label Study in Healthy Participants to Evaluate AZD0780 as an Object or Precipitant of CYP3A4-mediated Drug-drug Interactions
A Phase 1 study testing AZD0780, Itraconazole and Carbamazepine in people with Dyslipidaemia, run by AstraZeneca at 1 site in United States.
Trial summary
An open-label, fixed sequence study in healthy participants to assess the pharmacokinetics of AZD0780 when administered alone and in combination with itraconazole and carbamazepine, and to assess the pharmacokinetics of midazolam and ethinyl estradiol/levonorgestrel (EE and LNG) when administered alone and in… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidaemia
- What is being tested?
- AZD0780, Itraconazole and Carbamazepine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2024to 17 Feb 2025
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older 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 75 years with suitable veins for cannulation or repeated venipuncture. Part 4 only: Healthy female participants of non-childbearing potential aged 18 to 75 years with suitable veins for cannulation or repeated venipuncture.
- All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
- Females of non-childbearing potential must be confirmed at the Screening Visit by fulfilling one of the following criteria:
- Postmenopausal defined as amenorrhea for at least 12 months following cessation of all exogenous hormonal treatments and FSH levels in the postmenopausal range.
- Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation or tubal occlusion.
- Sexually active fertile male participants with partners of childbearing potential must adhere to the contraception methods detailed in Appendix C 2.1 from the time of first administration of AZD0780 administration until 3 months after the study Follow-up Visit.
- Have a BMI between 18 and 35 kg/m2 inclusive and weight at least 50 kg at the Screening Visit and on admission to the Clinical Unit.
Who cannot join
- History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
- History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Any prior gastrointestinal surgery which may affect absorption, eg, gastric bypass or resection.
- Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.
- Any laboratory values with the following deviations at the Screening Visit or on admission to the Clinical Unit. Abnormal values may be repeated once at the discretion of the Investigator.
- Any clinically important abnormalities in clinical chemistry, hematology, or urinalysis results other than those described under exclusion criterion number 5, at screening and/or admission to the Clinical Unit, as judged by the Investigator. Abnormal values may be repeated once at the discretion of the Investigator.
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- Any positive result at Screening for serum HBsAg, HBcAb, HCV, or HIV.
- Any clinically significant abnormal findings in abnormal vital signs, after at least 10 minutes supine rest, at Screening and on admission to the Clinical Unit, as judged by the Investigator. Abnormal values may be repeated once at the discretion of the Investigator..
- Any clinically important abnormalities in rhythm, conduction or morphology of the resting ECG and any clinically important abnormalities in the 12-lead ECG as considered by the Investigator that may interfere with the interpretation of QTc interval changes.
- Current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the previous 3 months prior to screening.
- Known or suspected history of alcohol or drug abuse or excessive intake of alcohol as judged by the Investigator.
- Positive screen for drugs of abuse, alcohol, or cotinine at Screening or on admission to the Clinical Unit.
- History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD0780, itraconazole (Part 1 only), carbamazepine (Part 2 only), midazolam (Part 3 only), or EE/LNG (Part 4 only).
- Excessive intake of caffeine-containing drinks or food (eg, coffee, tea, chocolate) defined as the regular consumption of more than 500 mg of caffeine per day (eg, > 5 cups of coffee [one cup ~100 mg caffeine]; one cup of tea ~30 mg caffeine) or would likely be unable to refrain from the use of caffeine-containing beverages during confinement at the Clinical Unit.
- Use of drugs with enzyme inducing properties such as St John's Wort within 3 weeks prior to the first administration of study intervention.
- Use of any prescribed or nonprescribed medication including hormone replacement therapy, antacids or acid reducing agents (including proton pump inhibitors),analgesics (other than paracetamol/acetaminophen), herbal remedies, mega dose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the 2 weeks prior to the first administration of study intervention or longer if the medication has a long half-life.
- Plasma donation within one month of the Screening Visit or any blood donation/blood loss > 500 mL during the 3 months prior to the Screening Visit.
- Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 30 days or 5 half-lives (whichever is longest) of the first administration of the study intervention in this study. NOTE: participants consented and screened, but not enrolled/randomized in this study or a previous Phase I study, are not excluded. NOTE: All follow-up activities in a previous research study (including last study visit, unresolved AEs, or abnormal laboratory values) have to be completed prior to the Screening Visit. NOTE: Participants must be checked in VCT in the USA.
- Participants who have previously received AZD0780 within 60 days prior to Screening.
- Current/previous use of drugs that reduce or inhibit PCSK9 (approved or investigational; within 12 months of enrolment). Any current/previous use of inclisiran.
- Elevated or abnormal liver enzymes or active liver disease, or who have experienced liver toxicity with other drugs.
- Known or confirmed for HLA-A*3101 and/or HLA-B*1502 allele at Screening (Part 2 only).
- Participant who previously experienced hypersensitivity reaction to anticonvulsants including phenytoin, primidone, and phenobarbital.
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the Clinical Unit).
- Judgment by the Investigator that the participant should not participate in the study if they have any ongoing or recent (ie, during the Screening period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions, and requirements.
- Participants who are vegans or have medical dietary restrictions.
- Participants who cannot communicate reliably with the Investigator.
- Vulnerable participants, eg, kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label Study in Healthy Participants to Assess the Pharmacokinetics of AZD0780 When Administered Alone and in Combination With Itraconazole or Carbamazepine, and to Assess the Pharmacokinetics of Midazolam, and Ethinyl Estradiol/Levonorgestrel When Administered Alone and in Combination With AZD0780
An open-label, fixed sequence study in healthy participants to assess the pharmacokinetics of AZD0780 when administered alone and in combination with itraconazole and carbamazepine, and to assess the pharmacokinetics of midazolam and ethinyl estradiol/levonorgestrel (EE and LNG) when administered alone and in combination with AZD0780.
Read the detailed description
The purpose of this study is to quantify the effect of itraconazole, a strong CYP3A inhibitor, and carbamazepine, a strong CYP3A inducer, on the PK of AZD0780 in healthy participants. This study will also evaluate AZD0780 as a precipitant of CYP3A4 mediated DDI by examining the PK of midazolam (a CYP3A4 substrate) and EE and LNG (CYP3A4 substrates) alone and in combination with AZD0780 in healthy participants.
The study duration (including screening period) will be approximately 9 to 10 weeks for Part 1, 12 to 14 weeks for Part 2, 6 to 8 weeks for Part 3, and 8 to 10 weeks for Part 4 (optional).
Study visits and treatment:
- Part 1: Participants who are eligible to participate in this study will stay at the Clinical Unit from Day -1 to Day 24 and return to the Clinical Unit again for a Follow-up Visit, 7 to 14 days after the last PK sample.
- Part 2: Participants who are eligible to participate in this study will stay at the Clinical Unit from Day -1 to Day 37 and return to the Clinical Unit again for a Follow-up Visit, 7 to 14 days after the last PK sample.
- Part 3: Participants who are eligible to participate in this study will stay at the Clinical Unit from Day -1 to Day 12 and return to the Clinical Unit again for a Follow-up Visit, 7 to 14 days after the last PK sample.
- Part 4 (optional): Participants who are eligible to participate in this study will stay at the Clinical Unit from Day -1 to Day 22 and return to the Clinical Unit again for a Follow-up Visit, 7 to 14 days after the last PK sample.
Number of Participants:
Approximately 78 participants will be enrolled in this study; 18 participants in Part 1 (itraconazole Cohort), 24 participants in Part 2 (carbamazepine Cohort), 18 participants in Part 3 (midazolam Cohort), and 18 Participants in Part 4 (EE and LNG Cohort) (optional).
- Conditions
- Dyslipidaemia
- Being tested
- AZD0780, Itraconazole, Carbamazepine, Midazolam, Ethinyl estradiol/levonorgestrel
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD0780Drug
Dose 1 and Dose 2
ItraconazoleDrug
- Period 2 (itraconazole administration only).
- Period 3 (AZD0780 + itraconazole administration).
CarbamazepineDrug
- Period 2 (carbamazepine administration only).
- Period 3 (AZD0780 + carbamazepine administration only).
MidazolamDrug
- Period 1 (midazolam administration only).
- Period 3 (AZD0780 + midazolam administration).
Ethinyl estradiol/levonorgestrelDrug
- Period 1 (EE and LNG administration only).
- Period 3 (AZD0780 + EE and LNG administration).
| Study group | Role | What they receive |
|---|---|---|
| Itraconazole Cohort | Experimental | * All participants will receive 2 single doses of dose 1 of AZD0780 and 14 doses of itraconazole, under fed conditions.
* This part will consist of Period 1 (AZD0780 administration only), Period 2 (itraconazole administration only), and Period 3 (AZD0780 + itraconazole administration). Receives: Drug: AZD0780; Drug: Itraconazole |
| Carbamazepine Cohort | Experimental | * All participants will receive 2 single doses of dose 1 of AZD0780 and 6 doses of 100 mg, 6 doses of 200 mg, and 40 doses of 300 mg carbamazepine, under fed conditions.
* This part will consist of Period 1 (AZD0780 administration only), Period 2 (carbamazepine administration only), and Period 3 (AZD0780 + carbamazepine administration) Receives: Drug: AZD0780; Drug: Carbamazepine |
| Midazolam Cohort | Experimental | * All participants will receive 10 single doses of AZD0780 dose 2 and 2 doses of midazolam. On midazolam dosing days, participants will receive midazolam under fasted conditions.
* This part will consist of Period 1 (midazolam administration only), Period 2 (AZD0780 administration only), and Period 3 (AZD0780 + midazolam administration). Receives: Drug: AZD0780; Drug: Midazolam |
| EE and LNG Cohort | Experimental | * All participants will receive 15 single doses of AZD0780 dose 2 and 2 doses of EE and LNG. On EE and LNG dosing days, participants will receive EE and LNG under fasted conditions.
* This part will consist of Period 1 (EE and LNG administration only), Period 2 (AZD0780 administration only), and Period 3 (AZD0780 + EE and LNG administration). Receives: Drug: AZD0780; Drug: Ethinyl estradiol/levonorgestrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCinf (Area under concentration-time curve from time 0 to infinity)
To describe the PK of AZD0780 when administered alone and in combination with itraconazole and carbamazepine.
Measured: Period 1 (Day 1 to 11 Cohort 1 and Cohort 2) and Period 3 (Day 14-24 Part 1 and Day 27-37 Part 2)
AUClast (Area under concentration curve from time 0 to the last quantifiable concentration)
To describe the PK of AZD0780 when administered alone and in combination with itraconazole and carbamazepine.
Measured: Period 1 (Day 1 to 11 Cohort 1 and Cohort 2) and Period 3 (Day 14-24 Part 1 and Day 27-37 Part 2)
Cmax (Maximum observed drug concentration)
To describe the PK of AZD0780 when administered alone and in combination with itraconazole and carbamazepine.
Measured: Period 1 (Day 1 to 11 Cohort 1 and Cohort 2) and Period 3 (Day 14-24 Part 1 and Day 27-37 Part 2)
AUCinf
To assess the effect of AZD0780 on the PK of midazolam (Part 3) and EE and LNG (Part 4).
Measured: Period 1 (Day 1 to 2 Part 3 and Day 1 to 7 Part 4) and Period 3 (Day 11-12 Part 3 and Day 16 to 22 Part 4)
AUClast
To assess the effect of AZD0780 on the PK of midazolam (Part 3) and EE and LNG (Part 4).
Measured: Period 1 (Day 1 to 2 Part 3 and Day 1 to 7 Part 4) and Period 3 (Day 11-12 Part 3 and Day 16 to 22 Part 4)
Cmax
To assess the effect of AZD0780 on the PK of midazolam (Part 3) and EE and LNG (Part 4).
Measured: Period 1 (Day 1 to 2 Part 3 and Day 1 to 7 Part 4) and Period 3 (Day 11-12 Part 3 and Day 16 to 22 Part 4)
Secondary outcomes (11)
CL/F (Apparent total body clearance)
To describe the PK of AZD0780 when administered alone, in combination with itraconazole or in combination with carbamazepine.
Measured: Period 1 (Day 1 to 11 Cohort 1 and Cohort 2) and Period 3 (Day 14-24 Part 1 and Day 27-37 Part 2)
t½λz (Terminal elimination half-life)
To describe the PK of AZD0780 when administered alone, in combination with itraconazole or in combination with carbamazepine.
Measured: Period 1 (Day 1 to 11 Cohort 1 and Cohort 2) and Period 3 (Day 14-24 Part 1 and Day 27-37 Part 2)
tmax (Time to reach maximum observed concentration)
To describe the PK of AZD0780 when administered alone, in combination with itraconazole or in combination with carbamazepine.
Measured: Period 1 (Day 1 to 11 Cohort 1 and Cohort 2) and Period 3 (Day 14-24 Part 1 and Day 27-37 Part 2)
Vz/F (Apparent volume of distribution based on the terminal phase)
To describe the PK of AZD0780 when administered alone, in combination with itraconazole or in combination with carbamazepine.
Measured: Period 1 (Day 1 to 11 Cohort 1 and Cohort 2) and Period 3 (Day 14-24 Part 1 and Day 27-37 Part 2)
Number of participants with Adverse Events and Serious Adverse Events (AEs and SAEs)
To assess the safety and tolerability of AZD0780 when administered alone and in combination with itraconazole, carbamazepine, midazolam and EE and LNG.
Measured: From Baseline until Follow-up Visit (7 to 14 days post-discharge)
Number of participants with treatment emergent abnormal ECGs
To assess the safety and tolerability of AZD0780 when administered alone and in combination with itraconazole, carbamazepine, midazolam and EE and LNG.
Measured: From Baseline until Follow-up Visit (7 to 14 days post-discharge)
Vital signs and laboratory test results
To assess the safety and tolerability of AZD0780 when administered alone and in combination with itraconazole, carbamazepine, midazolam and EE and LNG.
Measured: From Baseline until Follow-up Visit (7 to 14 days post-discharge)
CL/F
To describe the PK of midazolam (Part 3) and EE and LNG (Part 4) when administered alone and in combination with AZD0780.
Measured: Period 1 (Day 1 to 2 Part 3 and Day 1 to 7 Part 4) and Period 3 (Day 11-12 Part 3 and Day 16 to 22 Part 4)
t½λz
To describe the PK of midazolam (Part 3) and EE and LNG (Part 4) when administered alone and in combination with AZD0780.
Measured: Period 1 (Day 1 to 2 Part 3 and Day 1 to 7 Part 4) and Period 3 (Day 11-12 Part 3 and Day 16 to 22 Part 4)
tmax
TTo describe the PK of midazolam (Part 3) and EE and LNG (Part 4) when administered alone and in combination with AZD0780.
Measured: Period 1 (Day 1 to 2 Part 3 and Day 1 to 7 Part 4) and Period 3 (Day 11-12 Part 3 and Day 16 to 22 Part 4)
Vz/F
To describe the PK of midazolam (Part 3) and EE and LNG (Part 4) when administered alone and in combination with AZD0780.
Measured: Period 1 (Day 1 to 2 Part 3 and Day 1 to 7 Part 4) and Period 3 (Day 11-12 Part 3 and Day 16 to 22 Part 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start25 Sep 2024
- Primary completion17 Feb 2025
- Study completion17 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidaemiaStudies 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- DDI study, open label, fixed sequence
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06671405
- Sponsor's protocol ID
- D7960C00011
- Status last verified
- Apr 2025
- First submitted
- 23 Sep 2024
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
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 Study in Healthy Participants to Assess the Pharmacokinetics of AZD0780 When Administered Alone and in Combination With Itraconazole or Carbamazepine, and to Assess the Pharmacokinetics of Midazolam, and Ethinyl Estradiol/Levonorgestrel When Administered Alone and in Combination With AZD0780
- ClinicalTrials.gov ID
- NCT06671405
- Acronym / sponsor ID
- D7960C00011
- Conditions
- Dyslipidaemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2024 (actual)
- Primary completion
- 17 Feb 2025 (actual)
- Study completion
- 17 Feb 2025 (actual)
- First posted
- 4 Nov 2024 (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.
An open-label, fixed sequence study in healthy participants to assess the pharmacokinetics of AZD0780 when administered alone and in combination with itraconazole and carbamazepine, and to assess the pharmacokinetics of midazolam and ethinyl estradiol/levonorgestrel (EE and LNG) when administered alone and in combination with AZD0780.
Detailed description
The purpose of this study is to quantify the effect of itraconazole, a strong CYP3A inhibitor, and carbamazepine, a strong CYP3A inducer, on the PK of AZD0780 in healthy participants. This study will also evaluate AZD0780 as a precipitant of CYP3A4 mediated DDI by examining the PK of midazolam (a CYP3A4 substrate) and EE and LNG (CYP3A4 substrates) alone and in combination with AZD0780 in healthy participants.
The study duration (including screening period) will be approximately 9 to 10 weeks for Part 1, 12 to 14 weeks for Part 2, 6 to 8 weeks for Part 3, and 8 to 10 weeks for Part 4 (optional).
Study visits and treatment:
- Part 1: Participants who are eligible to participate in this study will stay at the Clinical Unit from Day -1 to Day 24 and return to the Clinical Unit again for a Follow-up Visit, 7 to 14 days after the last PK sample.
- Part 2: Participants who are eligible to participate in this study will stay at the Clinical Unit from Day -1 to Day 37 and return to the Clinical Unit again for a Follow-up Visit, 7 to 14 days after the last PK sample.
- Part 3: Participants who are eligible to participate in this study will stay at the Clinical Unit from Day -1 to Day 12 and return to the Clinical Unit again for a Follow-up Visit, 7 to 14 days after the last PK sample.
- Part 4 (optional): Participants who are eligible to participate in this study will stay at the Clinical Unit from Day -1 to Day 22 and return to the Clinical Unit again for a Follow-up Visit, 7 to 14 days after the last PK sample.
Number of Participants:
Approximately 78 participants will be enrolled in this study; 18 participants in Part 1 (itraconazole Cohort), 24 participants in Part 2 (carbamazepine Cohort), 18 participants in Part 3 (midazolam Cohort), and 18 Participants in Part 4 (EE and LNG Cohort) (optional).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- DDI study, open label, fixed sequence
| Arm | Type | Receives |
|---|---|---|
| Itraconazole Cohort | Experimental | Drug: AZD0780, Drug: Itraconazole* All participants will receive 2 single doses of dose 1 of AZD0780 and 14 doses of itraconazole, under fed conditions. * This part will consist of Period 1 (AZD0780 administration only), Period 2 (itraconazole administration only), and Period 3 (AZD0780 + itraconazole administration). |
| Carbamazepine Cohort | Experimental | Drug: AZD0780, Drug: Carbamazepine* All participants will receive 2 single doses of dose 1 of AZD0780 and 6 doses of 100 mg, 6 doses of 200 mg, and 40 doses of 300 mg carbamazepine, under fed conditions. * This part will consist of Period 1 (AZD0780 administration only), Period 2 (carbamazepine administration only), and Period 3 (AZD0780 + carbamazepine administration) |
| Midazolam Cohort | Experimental | Drug: AZD0780, Drug: Midazolam* All participants will receive 10 single doses of AZD0780 dose 2 and 2 doses of midazolam. On midazolam dosing days, participants will receive midazolam under fasted conditions. * This part will consist of Period 1 (midazolam administration only), Period 2 (AZD0780 administration only), and Period 3 (AZD0780 + midazolam administration). |
| EE and LNG Cohort | Experimental | Drug: AZD0780, Drug: Ethinyl estradiol/levonorgestrel* All participants will receive 15 single doses of AZD0780 dose 2 and 2 doses of EE and LNG. On EE and LNG dosing days, participants will receive EE and LNG under fasted conditions. * This part will consist of Period 1 (EE and LNG administration only), Period 2 (AZD0780 administration only), and Period 3 (AZD0780 + EE and LNG administration). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 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 75 years with suitable veins for cannulation or repeated venipuncture. Part 4 only: Healthy female participants of non-childbearing potential aged 18 to 75 years with suitable veins for cannulation or repeated venipuncture.
- All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
- Females of non-childbearing potential must be confirmed at the Screening Visit by fulfilling one of the following criteria:
- Sexually active fertile male participants with partners of childbearing potential must adhere to the contraception methods detailed in Appendix C 2.1 from the time of first administration of AZD0780 administration until 3 months after the study Follow-up Visit.
Key exclusion criteria (28 listed)
- History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
- History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Any prior gastrointestinal surgery which may affect absorption, eg, gastric bypass or resection.
- Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.
- Any laboratory values with the following deviations at the Screening Visit or on admission to the Clinical Unit. Abnormal values may be repeated once at the discretion of the Investigator.
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 |
|---|---|---|
| AZD0780Dose 1 and Dose 2 | Drug | Carbamazepine Cohort, EE and LNG Cohort, Itraconazole Cohort, Midazolam Cohort |
| Itraconazole* Period 2 (itraconazole administration only). * Period 3 (AZD0780 + itraconazole administration). | Drug | Itraconazole Cohort |
| Carbamazepine* Period 2 (carbamazepine administration only). * Period 3 (AZD0780 + carbamazepine administration only). | Drug | Carbamazepine Cohort |
| Midazolam* Period 1 (midazolam administration only). * Period 3 (AZD0780 + midazolam administration). | Drug | Midazolam Cohort |
| Ethinyl estradiol/levonorgestrel* Period 1 (EE and LNG administration only). * Period 3 (AZD0780 + EE and LNG administration). | Drug | EE and LNG Cohort |
Primary outcome
AUCinf (Area under concentration-time curve from time 0 to infinity)
Time frame: Period 1 (Day 1 to 11 Cohort 1 and Cohort 2) and Period 3 (Day 14-24 Part 1 and Day 27-37 Part 2)
To describe the PK of AZD0780 when administered alone and in combination with itraconazole and carbamazepine.
AUClast (Area under concentration curve from time 0 to the last quantifiable concentration)
Time frame: Period 1 (Day 1 to 11 Cohort 1 and Cohort 2) and Period 3 (Day 14-24 Part 1 and Day 27-37 Part 2)
To describe the PK of AZD0780 when administered alone and in combination with itraconazole and carbamazepine.
Cmax (Maximum observed drug concentration)
Time frame: Period 1 (Day 1 to 11 Cohort 1 and Cohort 2) and Period 3 (Day 14-24 Part 1 and Day 27-37 Part 2)
To describe the PK of AZD0780 when administered alone and in combination with itraconazole and carbamazepine.
AUCinf
Time frame: Period 1 (Day 1 to 2 Part 3 and Day 1 to 7 Part 4) and Period 3 (Day 11-12 Part 3 and Day 16 to 22 Part 4)
To assess the effect of AZD0780 on the PK of midazolam (Part 3) and EE and LNG (Part 4).
AUClast
Time frame: Period 1 (Day 1 to 2 Part 3 and Day 1 to 7 Part 4) and Period 3 (Day 11-12 Part 3 and Day 16 to 22 Part 4)
To assess the effect of AZD0780 on the PK of midazolam (Part 3) and EE and LNG (Part 4).
Cmax
Time frame: Period 1 (Day 1 to 2 Part 3 and Day 1 to 7 Part 4) and Period 3 (Day 11-12 Part 3 and Day 16 to 22 Part 4)
To assess the effect of AZD0780 on the PK of midazolam (Part 3) and EE and LNG (Part 4).
11 secondary outcomes
CL/F (Apparent total body clearance)
Time frame: Period 1 (Day 1 to 11 Cohort 1 and Cohort 2) and Period 3 (Day 14-24 Part 1 and Day 27-37 Part 2)
t½λz (Terminal elimination half-life)
Time frame: Period 1 (Day 1 to 11 Cohort 1 and Cohort 2) and Period 3 (Day 14-24 Part 1 and Day 27-37 Part 2)
tmax (Time to reach maximum observed concentration)
Time frame: Period 1 (Day 1 to 11 Cohort 1 and Cohort 2) and Period 3 (Day 14-24 Part 1 and Day 27-37 Part 2)
Vz/F (Apparent volume of distribution based on the terminal phase)
Time frame: Period 1 (Day 1 to 11 Cohort 1 and Cohort 2) and Period 3 (Day 14-24 Part 1 and Day 27-37 Part 2)
Number of participants with Adverse Events and Serious Adverse Events (AEs and SAEs)
Time frame: From Baseline until Follow-up Visit (7 to 14 days post-discharge)
Number of participants with treatment emergent abnormal ECGs
Time frame: From Baseline until Follow-up Visit (7 to 14 days post-discharge)
Vital signs and laboratory test results
Time frame: From Baseline until Follow-up Visit (7 to 14 days post-discharge)
CL/F
Time frame: Period 1 (Day 1 to 2 Part 3 and Day 1 to 7 Part 4) and Period 3 (Day 11-12 Part 3 and Day 16 to 22 Part 4)
t½λz
Time frame: Period 1 (Day 1 to 2 Part 3 and Day 1 to 7 Part 4) and Period 3 (Day 11-12 Part 3 and Day 16 to 22 Part 4)
tmax
Time frame: Period 1 (Day 1 to 2 Part 3 and Day 1 to 7 Part 4) and Period 3 (Day 11-12 Part 3 and Day 16 to 22 Part 4)
Vz/F
Time frame: Period 1 (Day 1 to 2 Part 3 and Day 1 to 7 Part 4) and Period 3 (Day 11-12 Part 3 and Day 16 to 22 Part 4)
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.
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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, Itraconazole and Carbamazepine in people with Dyslipidaemia, 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 8 inclusion and 28 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?
AUCinf (Area under concentration-time curve from time 0 to infinity) (time frame: Period 1 (Day 1 to 11 Cohort 1 and Cohort 2) and Period 3 (Day 14-24 Part 1 and Day 27-37 Part 2)). The study lists 6 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.