AZD0780 for Drug Interaction Study

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: AstraZeneca

Must not be taking: Anticonvulsants, Enzyme inducers, PCSK9 inhibitors

Disqualifiers: Gastrointestinal disease, Liver disease, Drug abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

59 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires participants to stop taking any prescribed or nonprescribed medications, including hormone replacement therapy, antacids, and herbal remedies, for at least 2 weeks before starting the study. This means you will need to stop your current medications during this period.

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for healthy individuals aged 18 to 75 who are interested in helping study the effects of a new cholesterol medication, AZD0780. Participants should not have dyslipidemia or high cholesterol.

Inclusion Criteria

Provision of signed and dated, written informed consent prior to any study-specific procedures

I have tested negative for pregnancy before starting the trial.

I am a woman who cannot become pregnant.

Exclusion Criteria

I have recently used experimental drugs.

I have no conditions that affect how drugs are broken down in my body.

I have not donated blood or plasma recently.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4-5 weeks

Treatment Part 1

Participants receive AZD0780 alone and in combination with itraconazole

3-4 weeks

In-patient stay from Day -1 to Day 24

Treatment Part 2

Participants receive AZD0780 alone and in combination with carbamazepine

5-6 weeks

In-patient stay from Day -1 to Day 37

Treatment Part 3

Participants receive AZD0780 alone and in combination with midazolam

2-3 weeks

In-patient stay from Day -1 to Day 12

Treatment Part 4

Participants receive AZD0780 alone and in combination with EE and LNG

3-4 weeks

In-patient stay from Day -1 to Day 22

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

1 visit (in-person) 7 to 14 days post-discharge

Treatment Details

Interventions

• AZD0780

Trial Overview The study is looking at how the body processes a new drug called AZD0780 when taken alone and alongside other medications, Itraconazole and Carbamazepine. It's an open-label trial where everyone knows what treatment they're getting.

Participant Groups

Group I: Midazolam Cohort Experimental Treatment 2 Interventions

* 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).

Group II: Itraconazole Cohort Experimental Treatment 2 Interventions

* 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).

Group III: EE and LNG Cohort Experimental Treatment 2 Interventions

* 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).

Group IV: Carbamazepine Cohort Experimental Treatment 2 Interventions

* 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)

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology