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

NCT06494644 | Completed Phase 1

• 2 other identifiers: D7860C000042023-509002-30-00
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Participants

Keywords

AZD6793; Itraconazole; Chronic obstructive pulmonary disease

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (1)

• Number of participants with adverse events

  From first dose (Day 1) until Follow-up (10-15 days post last itraconazole dose)

Study Arms (1)

AZD6793 and Itraconazole

EXPERIMENTAL

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; Drug: Itraconazole; Drug: AZD6793+ Itraconazole

Interventions

AZD6793 DRUG

Participants will receive single dose of AZD6793 on Day 1 in Period 1 and on Day 8 in combination with itraconazole in Period 3.

AZD6793 and Itraconazole

Itraconazole DRUG

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.

AZD6793 and Itraconazole

AZD6793+ Itraconazole DRUG

Participants will receive a combined dose of AZD6793 and itraconazole on Day 8 in Period 3.

AZD6793 and Itraconazole

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Berlin, 14050, Germany

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Itraconazole

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is an open-label, single-group, 3 period fixed sequence study.

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 10, 2024
• Study Start: July 23, 2024
• Primary Completion: October 5, 2024
• Study Completion: October 5, 2024
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• 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.
• 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.

Locations

DE (1)