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A Study to Investigate the Pharmacokinetics of AZD0780 When Administered Alone and in Combination With Itraconazole and Carbamazepine in Healthy Participants Aged 18 to 75 Years of Age

Phase 1

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have a BMI between 18 and 35 kg/m2 inclusive and weigh at least 50 kg at the Screening Visit and on admission to the Clinical Unit

Be older than 18 years old

Must not have

Recent plasma or blood donation

Inability to communicate reliably with the Investigator

Timeline

Screening 3 weeks

Treatment Varies

Follow Up period 1 (day 1 to 11 both parts) and period 3 (day 14-24 part 1 and day 27-37 part 2)

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how a medication called AZD0780 behaves in the body when taken alone and when taken with other medications, itraconazole and carbamazepine, in healthy individuals

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects may include issues related to liver function changes due to Itraconazole, dizziness or drowsiness from Carbamazepine, and any unknown risks associated with the new drug AZD0780.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My BMI is between 18 and 35, and I weigh at least 50 kg.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not donated blood or plasma recently.

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I can communicate clearly with my doctor.

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I am not taking any drugs that increase enzyme activity.

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My HLA type has been confirmed.

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I have had stomach or intestine surgery that affects how I absorb food or medicine.

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I am taking PCSK9 inhibitors.

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I have liver problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ period 1 (day 1 to 11 both parts) and period 3 (day 14-24 part 1 and day 27-37 part 2)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~period 1 (day 1 to 11 both parts) and period 3 (day 14-24 part 1 and day 27-37 part 2)

This trial's timeline: 3 weeks for screening, Varies for treatment, and period 1 (day 1 to 11 both parts) and period 3 (day 14-24 part 1 and day 27-37 part 2) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

AUCinf (Area under concentration-time curve from time 0 to infinity)

AUClast (Area under concentration curve from time 0 to the last quantifiable concentration)

Cmax (Maximum observed drug concentration)

Secondary study objectives

Adverse Events and Serious Adverse Events (AEs and SAEs)

CL/F (Apparent total body clearance)

Number of participants with abnormal laboratory test results

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Itraconazole CohortExperimental Treatment2 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 II: Carbamazepine CohortExperimental Treatment2 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)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Itraconazole

2017

Completed Phase 2

~830

AZD0780

2024

Completed Phase 2

~630