A Study to Assess the Pharmacokinetics of AZD6793 When Administered Alone and in Combination With Itraconazole in Healthy Participants.

An Open-label, Single-group, Three-period, Fixed-sequence, Phase I Study to Assess the Pharmacokinetics of AZD6793 Tablets When Administered Alone and in Combination With Itraconazole Capsules in Healthy Adult Female and Male Participants.

The study will evaluate the pharmacokinetics (PK) of AZD6793 when administered alone and in combination with itraconazole in healthy adult participants.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: AZD6793; Drug: Itraconazole; Drug: AZD6793+ Itraconazole

Detailed Description

This is a single-group study with a duration of up to 8 weeks (maximum of 53 days) including Screening, Period 1, Period 2, Period 3 and Follow-up.

The study will comprise of:

• A screening period of 27 days
• Three treatment periods: Period 1 (Day -1 to Day 3): Single dose AZD6793 will be administered on Day 1 followed by a 3-day washout period; Period 2 (Day 4 to Day 7): Itraconazole will be administered from Day 4 through Day 7, starting with 2 doses of 200 mg itraconazole given 12 hours apart on Day 4, then 200 mg itraconazole will be given once a day on Day 5 through Day 7. Period 3 (Day 8 to Day 11): On Day 8, participants will be co-administered with AZD6793 and 200 mg itraconazole. Administration of 200 mg itraconazole will continue on Day 9 and Day 10. Participants will be discharged from the clinic on Day 11.
• A Follow-up Visit 10-15 days after the last itraconazole dose in Period 3.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 14050
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Main Inclusion Criteria:

• Female participants must have a negative pregnancy test at screening and on admission and must not be lactating.
• Females of childbearing potential must not be lactating and, if heterosexually active, must agree to use with their partner an approved method of highly effective contraception to avoid pregnancy.
• Females of non-childing potential must be confirmed at the Screening Visit.
• Sexually active fertile male participants with partners of childbearing potential must adhere to the contraception methods from Screening visit until 3 months after Follow-up visit.
• Participants with Body mass index between 18 and 30 kg/m², and at least 50 kg at the Screening Visit.
• Participants should be fully/sufficiently vaccinated against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as per current local regulations.

Main Exclusion Criteria:

• History of any clinically significant disease or disorder which 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, renal, or pancreatic disease, or any other clinically significant disease or disorder known to interfere with absorption, distribution, metabolism, or excretion of drugs.
• History of clinically significant chronic or active hematologic disease.
• Diagnosis or history of immunodeficiency or increased susceptibility to severe infection, or a clinically significant infection within 4 weeks of the Screening Visit.
• Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of study drug.
• Any laboratory values with deviations at the Screening Visit or on admission to the Clinical Unit. Abnormal values may be repeated at the discretion of the Investigator: Alanine transaminase (ALT) > Upper Limit Normal (ULN), Aspartate Transaminase (AST) > ULN, WBC count < Lower limit normal (LLN), Neutrophils > ULN or < LLN, Haemoglobin < 120 g/L, Bilirubin > ULN, Urinary albumin to creatinine ratio abnormal (≥ 3.4 mg/mmol), eGlomerular filtration rate (eGFR) < 85 mL/min/1.73 m² calculated using the CKD-EPI equation (eGFR will only be assessed at Screening).
• Any clinically important abnormalities in clinical chemistry, haematology, or urinalysis results at the screening.
• Positive or indeterminate QuantiFERON® TB test at the Screening Visit.
• Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, or Human immunodeficiency virus (HIV).
• Participants with a history or presence of vitiligo or significant (in the opinion of the investigator) skin depigmentation for any cause including drugs.
• Any clinically significant abnormal finding in vital signs, at the Screening Visit and/or on admission to the Clinical Unit.
• Any clinically important abnormalities in rhythm, conduction or morphology of the resting electrocardiogram (ECG) and any clinically important abnormalities in the 12 lead ECG.
• Current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the 3 months prior to screening.
• Known or suspected history of alcohol or drug abuse or excessive intake of alcohol.
• Positive screen for drugs of abuse, alcohol, or cotinine (nicotine) at screening visit or on admission to the Clinical Unit.
• History or presence of severe allergy/hypersensitivity.
• Excessive intake of caffeine-containing drinks or food.
• 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.
• Use of any prescribed or nonprescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, mega dose vitamins (intake of >3 times the recommended daily dose) and minerals during the 2 weeks or 5 half-lives of the medication, whichever is longer, prior to the first administration of study drug. The use of hormonal replacement therapy for females is not permitted.
• Plasma donation within 1 month of screening or any blood donation/loss more than 500 mL during the 3 months prior to screening.
• 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 study intervention in this study.
• Participants who have previously received AZD6793.
• Vulnerable participants.
• Participant has a positive test result for SARS-CoV-2 via RT-PCR on admission to the Clinical Unit.
• Participant has clinical signs and symptoms consistent with Coronavirus disease 2019 (COVID-19).
• Participant who had severe course of COVID-19.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: AZD6793 and Itraconazole; Participants will receive a single dose of AZD6793 on Day 1. On Day 4, the participant will receive 2 doses of 200 mg itraconazole 12 hours apart followed by a single dose of 200 mg itraconazole from Days 5 to 7. On Day 8, participants will receive a combined dose of AZD6793 and 200 mg itraconazole. On Day 9 and Day 10, the participants will receive a single dose of 200 mg itraconazole.

Drug: AZD6793; Participants will receive single dose of AZD6793 on Day 1 in Period 1 and on Day 8 in combination with itraconazole in Period 3.; Drug: Itraconazole; Participants will receive 2 doses of itraconazole on Day 4 and single dose from Day 5 to Day 7 in Period 2. On Day 8 participants will receive single dose of itraconazole combined with AZD6793 and then single dose of itraconazole from Day 9 to Day 10 in Period 3.; Drug: AZD6793+ Itraconazole; Participants will receive a combined dose of AZD6793 and itraconazole on Day 8 in Period 3.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum plasma drug concentration (Cmax)	The effect of itraconazole on the single-dose Cmax of AZD6793 will be evaluated in healthy participants.	Post-dose on Day 1 to Day 3; and Day 8 to Day 11
Area under plasma concentration-time curve from time 0 to the last quantifiable concentration (AUClast)	The effect of itraconazole on the single-dose AUClast of AZD6793 will be evaluated in healthy participants.	Post-dose on Day 1 to Day 3; and Day 8 to Day 11
Area under plasma concentration-time curve from time 0 to infinity (AUCinf)	The effect of itraconazole on the single-dose AUCinf of AZD6793 will be evaluated in healthy participants.	Post-dose on Day 1 to Day 3; and Day 8 to Day 11
Apparent total body clearance (CL/F)	The effect of itraconazole on the single-dose CL/F of AZD6793 will be evaluated in healthy participants.	Post-dose on Day 1 to Day 3; and Day 8 to Day 11
Terminal elimination half-life (t1/2λz)	The effect of itraconazole on the single-dose t1/2λz of AZD6793 will be evaluated in healthy participants.	Post-dose on Day 1 to Day 3; and Day 8 to Day 11
Time to reach maximum observed concentration (tmax)	The effect of itraconazole on the single-dose tmax of AZD6793 will be evaluated in healthy participants.	Post-dose on Day 1 to Day 3; and Day 8 to Day 11
Apparent volume of distribution during the terminal phase (Vz/F)	The effect of itraconazole on the single-dose Vz/F of AZD6793 will be evaluated in healthy participants.	Post-dose on Day 1 to Day 3; and Day 8 to Day 11
Ratio Area under plasma concentration-time curve from time 0 to infinity (RAUCinf)	The effect of itraconazole on the single-dose RAUCinf of AZD6793 will be evaluated in healthy participants.	Post-dose on Day 1 to Day 3; and Day 8 to Day 11
Ratio Area under plasma concentration-time curve from time 0 to the last quantifiable concentration (RAUClast)	The effect of itraconazole on the single-dose RAUClast of AZD6793 will be evaluated in healthy participants.	Post-dose on Day 1 to Day 3; and Day 8 to Day 11
Ratio Maximum plasma drug concentration (RCmax)	The effect of itraconazole on the single-dose RCmax of AZD6793 will be evaluated in healthy participants.	Post-dose on Day 1 to Day 3; and Day 8 to Day 11

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events	The safety and tolerability after administration of AZD6793 with itraconazole will be evaluated.	From first dose (Day 1) until Follow-up (10-15 days post last itraconazole dose)

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2024
• Primary Completion (Actual): October 5, 2024
• Study Completion (Actual): October 5, 2024

Study Registration Dates

• First Submitted: July 3, 2024
• First Submitted That Met QC Criteria: July 3, 2024
• First Posted (Actual): July 10, 2024

Study Record Updates

• Last Update Posted (Actual): May 31, 2025
• Last Update Submitted That Met QC Criteria: May 27, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Chronic obstructive pulmonary disease; Itraconazole; AZD6793
• Additional Relevant MeSH Terms: Anti-Infective Agents; Antifungal Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Enzyme Inhibitors; Steroid Synthesis Inhibitors; Hormone Antagonists; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP3A Inhibitors; 14-alpha Demethylase Inhibitors; Itraconazole; Hydroxyitraconazole
• Other Study ID Numbers: D7860C00004; 2023-509002-30-00 (Other Identifier: EU-CT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No