Healthy ParticipantsPhase 1NCT06494644

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

A Phase 1 study testing AZD6793, Itraconazole and AZD6793+ Itraconazole in people with Healthy Participants, run by AstraZeneca at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Participants
What is being tested?: AZD6793, Itraconazole and AZD6793+ Itraconazole
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 17 participants
Where: 1 siteGermany
Study dates: 23 Jul 2024to 5 Oct 2024
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 55 years
All sexes
Healthy volunteers accepted
Adult

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.

Trial locations and contacts

1 site in 1 country.

Germany1 site

Research Site
Berlin, 14050

Other trials in Germany

About this study

Official title: 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.

Read the 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.

Conditions: Healthy Participants
Being tested: AZD6793, Itraconazole, AZD6793+ Itraconazole
Keywords: AZD6793, Itraconazole, Chronic obstructive pulmonary disease
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AZD6793Drug
Participants will receive single dose of AZD6793 on Day 1 in Period 1 and on Day 8 in combination with itraconazole in Period 3.
ItraconazoleDrug
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+ ItraconazoleDrug
Participants will receive a combined dose of AZD6793 and itraconazole on Day 8 in Period 3.

Study groups in NCT06494644
Study group	Role	What they receive
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. Receives: Drug: AZD6793; Drug: Itraconazole; Drug: AZD6793+ Itraconazole

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum plasma drug concentration (Cmax)
The effect of itraconazole on the single-dose Cmax of AZD6793 will be evaluated in healthy participants.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Post-dose on Day 1 to Day 3; and Day 8 to Day 11

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Jul 20245 Oct 2024

First posted10 Jul 2024
Study start23 Jul 2024
Primary completion5 Oct 2024
Study completion5 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy ParticipantsStudies 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: Not applicable
Intervention model: Single group
Model description: This is an open-label, single-group, 3 period fixed sequence study.
Masking: None (open label)
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06494644
Sponsor's protocol ID: D7860C00004
Other IDs: 2023-509002-30-00, 2023
Status last verified: May 2025
First submitted: 3 Jul 2024
Last updated: 31 May 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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.
ClinicalTrials.gov ID: NCT06494644
Acronym / sponsor ID: D7860C00004
Conditions: Healthy Participants
Keywords: AZD6793, Itraconazole, Chronic obstructive pulmonary disease
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 23 Jul 2024 (actual)
Primary completion: 5 Oct 2024 (actual)
Study completion: 5 Oct 2024 (actual)
First posted: 10 Jul 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.

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

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 design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: This is an open-label, single-group, 3 period fixed sequence study.

Arm	Type	Receives
AZD6793 and Itraconazole	Experimental	Drug: AZD6793, Drug: Itraconazole, Drug: AZD6793+ ItraconazoleParticipants 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.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

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
AZD6793Participants will receive single dose of AZD6793 on Day 1 in Period 1 and on Day 8 in combination with itraconazole in Period 3.	Drug	AZD6793 and Itraconazole
ItraconazoleParticipants 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 and Itraconazole
AZD6793+ ItraconazoleParticipants will receive a combined dose of AZD6793 and itraconazole on Day 8 in Period 3.	Drug	AZD6793 and Itraconazole

Primary outcome

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

1 secondary outcome

Number of participants with adverse events
Time frame: From first dose (Day 1) until Follow-up (10-15 days post last itraconazole dose)

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 31 May 2025.
Individual participant dataSharing planned: Yes. 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.

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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 AZD6793, Itraconazole and AZD6793+ Itraconazole in people with Healthy Participants, run by AstraZeneca at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 31 May 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 Germany. 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?

Maximum plasma drug concentration (Cmax) (time frame: Post-dose on Day 1 to Day 3; and Day 8 to Day 11). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06494644.

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 31 May 2025.