Healthy SubjectsPhase 1NCT05486949
Drug-drug Interactions Between AZD4205 and Itraconazole/Carbamazepine
A Phase 1 study testing AZD4205 and carbamazepine and AZD4205 and itraconazole in people with Healthy Subjects, run by Dizal Pharmaceuticals at 1 site in United States.
Trial summary
This is a Phase 1, single-center, nonrandomized, open-label, 2-part, fixed-sequence, drug-drug interaction (DDI) study to assess the effect of multiple doses of itraconazole, a CYP3A4 enzyme inhibitor, on the single dose PK of AZD4205 in healthy adult subjects (Part A) and to assess the effect of multiple doses of… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- AZD4205 and carbamazepine and AZD4205 and itraconazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2022to 11 Oct 2022
- 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
Who may be able to join
- Willing to participate in the study, give written informed consent, and comply with the study restrictions.
- Sex: male or female; females may be of childbearing potential, of nonchildbearing potential, or postmenopausal.
- Age: 18 to 55 years, inclusive, at screening.
- Body mass index (BMI): 18.0 to 30.0 kg/m2, inclusive, at screening.
- Weight: ≥55 kg for males and ≥45 kg for females at screening.
- Status: healthy subjects.
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- Healthy status as defined by the absence of evidence of any clinically significant, in the opinion of the investigator, active, or chronic disease.
- Ability and willingness to abstain from alcohol-, caffeine-, and methylxanthine containing beverages or food from 72 hours (3 days) prior to admission until discharge from the clinical facility.
- No clinically significant hematological or coagulation abnormalities, as judged by the investigator.
- Male subjects and female subjects of childbearing potential must agree to use protocol specified methods of contraception and comply with pregnancy precautions as described in the protocol.
- All prescription medications must have been stopped at least 28 days or 5 half lives, if known prior to the admission to the clinical research center.
- All over the counter medication must have been stopped at least 14 days or 5 half-lives, prior to the admission to the clinical research center.
- Normal baseline ECG (QTcF <450 msec, PR <220 msec).
- Adequate organ function, defined by the absence of any clinically significant abnormalities, as judged by the investigator, of the relevant baseline clinical safety assessments.
Who cannot join
- Employee of PRA or the sponsor.
- Any condition which, in the opinion of the investigator, would interfere with the subject's ability to provide informed consent, comply with study instructions, confound interpretation of study results, or endanger the subject if he or she takes part in the trial.
- Women who are pregnant, lactating, or planning to attempt to become pregnant during this study or within 30 days after the last dose of study drug.
- For all females of childbearing potential: positive pregnancy test at screening or at admission to the clinic.
- Males with female partners who are pregnant, lactating, or planning to attempt to become pregnant during this study or within 90 days after the last dose of study drug.
- Use of any investigational drug or device within 30 days, or investigational biologics within 120 days before the first dose of study drug.
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- Any disease which, in the opinion of the investigator, poses an unacceptable risk to the subject.
- Clinically relevant issues of visual function as determined from the medical history and physical exams, as judged by the investigator.
- Clinically significant history of any drug sensitivity, drug allergy, or food allergy, as determined by the investigator.
- History of allergy or hypersensitivity to AZD4205, or other drugs similar in class or similar in chemical structure to AZD4205, as judged by the investigator.
- History of major surgery or blood transfusion within 30 days prior to the first drug administration.
- History of malignancy of any type.
- Evidence of clinically significant or relevant renal, hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease.
- Manifestation of malabsorption due to prior gastrointestinal surgery, gastrointestinal disease, or any other reason that may affect the absorption of AZD4205.
- Positive result from a COVID-19 test per site policy and requirement.
- Positive test result for alcohol and/or drugs of abuse at screening or on Day -1.
- Positive test result from Quantiferon-TB Gold test.
- Presence of pulmonary infections or other clinically significant active infection within 30 days of informed consent.
- Received COVID-19 vaccine or any live vaccine within 4 weeks prior to the first dose of the investigational medicinal product.
- Self-reported substance abuse within 12 months of screening.
- Using tobacco or nicotine products within 90 days prior to the first drug administration.
- Strenuous activity, sunbathing, and contact sports within 48 hours prior to admission to the clinical facility through follow-up.
- History of donation of more than 500 mL of blood within 60 days prior to dosing in the clinical research center or planned donation before 30 days has elapsed since intake of study drug.
- Plasma or platelet donation within 7 days of dosing and through follow-up.
- History within the previous 12 months of alcohol consumption exceeding 2 standard drinks per day on average.
- Positive screening test for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, or HIV 1 and 2 antibodies.
- Consumption of any nutrients/foods known to modulate CYP450 enzyme activity within 7 days prior to administration of study drug and during the study.
- Abnormal echocardiogram (ECHO) at baseline, as judged by the investigator.
- History of allergy, severe adverse reaction, intolerance, or hypersensitivity to itraconazole or other azole antifungals, as determined by the investigator (Part A Only).
- History of allergy, severe adverse reaction, intolerance, or hypersensitivity to carbamazepine, carboxamide derivatives, or other drugs that are structurally related to carbamazepine, as judged by the investigator (Part B Only).
- Individuals who have Asian ancestry (including those who have 1 or more Asian grandparent, Part B Only).
Trial locations and contacts
1 site in 1 country.
United States1 site
Pharmaceutical Research Associates, Inc.
Lenexa, Kansas, 66219
About this study
Official title: A Phase 1, Single-Center, Nonrandomized, Open-Label, 2-Part, Fixed-Sequence, Drug-Drug Interaction Study to Assess the Pharmacokinetics and Safety of AZD4205 When Orally Administered Alone, When Coadministered With Itraconazole, and When Coadministered With Carbamazepine in Healthy Adult Subjects
This is a Phase 1, single-center, nonrandomized, open-label, 2-part, fixed-sequence, drug-drug interaction (DDI) study to assess the effect of multiple doses of itraconazole, a CYP3A4 enzyme inhibitor, on the single dose PK of AZD4205 in healthy adult subjects (Part A) and to assess the effect of multiple doses of carbamazepine, a CYP3A4 inducer, on the single dose PK of AZD4205 in healthy adult subjects (Part B).
- Conditions
- Healthy Subjects
- Being tested
- AZD4205 and carbamazepine, AZD4205 and itraconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD4205 and carbamazepineDrug
All subjects will receive AZD4205 single dose on Day 1, and the second dose of AZD4205 along with carbamazepine after the wash-out period.
AZD4205 and itraconazoleDrug
All subjects will receive AZD4205 single dose on Day 1, and the second dose of AZD4205 along with itraconazole after the wash-out period.
| Study group | Role | What they receive |
|---|---|---|
| AZD4205 and carbamazepine | Experimental | Subjects in arm 1 will receive AZD4205 single dose on Day 1, and the second dose of AZD4205 along with carbamazepine after the wash-out period. Receives: Drug: AZD4205 and carbamazepine |
| AZD4205 and itraconazole | Experimental | Subjects in arm 2 will receive AZD4205 single dose on Day 1, and the second dose of AZD4205 along with itraconazole after the wash-out period. Receives: Drug: AZD4205 and itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax) of AZD4205 when dosed alone or coadministered with itraconazole (Part A)
Measured: up to 10 days after study drug administration when AZD4205 dosed alone; up to 18 days after study drug administration when coadministered with itraconazole
Time to reach maximum plasma concentration (tmax) of AZD4205 when dosed alone or coadministered with itraconazole (Part A)
Measured: up to 10 days after study drug administration when AZD4205 dosed alone; up to 18 days after study drug administration when coadministered with itraconazole
Area under the concentration-time curve from time 0 to time of last quantifiable concentration (AUC0-t) when dosed alone or coadministered with itraconazole (Part A)
Measured: up to 10 days after study drug administration when AZD4205 dosed alone; up to 18 days after study drug administration when coadministered with itraconazole
Area under the concentration-time curve from time 0 to infinity (AUC0-inf) when dosed alone or coadministered with itraconazole (Part A)
Measured: up to 10 days after study drug administration when AZD4205 dosed alone; up to 18 days after study drug administration when coadministered with itraconazole
Maximum plasma concentration (Cmax) of AZD4205 when dosed alone or coadministered with carbamazepine (Part B)
Measured: up to 10 days after study drug administration
Time to reach maximum plasma concentration (tmax) of AZD4205 when dosed alone or coadministered with carbamazepine (Part B)
Measured: up to 10 days after study drug administration
Area under the concentration-time curve from time 0 to time of last quantifiable concentration (AUC0-t) when dosed alone or coadministered with carbamazepine (Part B)
Measured: up to 10 days after study drug administration
Area under the concentration-time curve from time 0 to infinity (AUC0-inf) when dosed alone or coadministered with carbamazepine (Part B)
Measured: up to 10 days after study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start27 Jul 2022
- Primary completion8 Oct 2022
- Study completion11 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Dizal PharmaceuticalsThe 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
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dizal Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shirlian Xu, Study director, Dizal Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05486949
- Sponsor's protocol ID
- DZ2021J0002
- Status last verified
- Jan 2023
- First submitted
- 2 Aug 2022
- Last updated
- 1 Feb 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-Center, Nonrandomized, Open-Label, 2-Part, Fixed-Sequence, Drug-Drug Interaction Study to Assess the Pharmacokinetics and Safety of AZD4205 When Orally Administered Alone, When Coadministered With Itraconazole, and When Coadministered With Carbamazepine in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT05486949
- Acronym / sponsor ID
- DZ2021J0002
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Dizal PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 27 Jul 2022 (actual)
- Primary completion
- 8 Oct 2022 (actual)
- Study completion
- 11 Oct 2022 (actual)
- First posted
- 4 Aug 2022 (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.
This is a Phase 1, single-center, nonrandomized, open-label, 2-part, fixed-sequence, drug-drug interaction (DDI) study to assess the effect of multiple doses of itraconazole, a CYP3A4 enzyme inhibitor, on the single dose PK of AZD4205 in healthy adult subjects (Part A) and to assess the effect of multiple doses of carbamazepine, a CYP3A4 inducer, on the single dose PK of AZD4205 in healthy adult subjects (Part B).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AZD4205 and carbamazepine | Experimental | Drug: AZD4205 and carbamazepineSubjects in arm 1 will receive AZD4205 single dose on Day 1, and the second dose of AZD4205 along with carbamazepine after the wash-out period. |
| AZD4205 and itraconazole | Experimental | Drug: AZD4205 and itraconazoleSubjects in arm 2 will receive AZD4205 single dose on Day 1, and the second dose of AZD4205 along with itraconazole after the wash-out period. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Willing to participate in the study, give written informed consent, and comply with the study restrictions.
- Sex: male or female; females may be of childbearing potential, of nonchildbearing potential, or postmenopausal.
- Age: 18 to 55 years, inclusive, at screening.
- Body mass index (BMI): 18.0 to 30.0 kg/m2, inclusive, at screening.
- Weight: ≥55 kg for males and ≥45 kg for females at screening.
Key exclusion criteria (31 listed)
- Employee of PRA or the sponsor.
- Any condition which, in the opinion of the investigator, would interfere with the subject's ability to provide informed consent, comply with study instructions, confound interpretation of study results, or endanger the subject if he or she takes part in the trial.
- Women who are pregnant, lactating, or planning to attempt to become pregnant during this study or within 30 days after the last dose of study drug.
- For all females of childbearing potential: positive pregnancy test at screening or at admission to the clinic.
- Males with female partners who are pregnant, lactating, or planning to attempt to become pregnant during this study or within 90 days after the last dose of study drug.
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 |
|---|---|---|
| AZD4205 and carbamazepineAll subjects will receive AZD4205 single dose on Day 1, and the second dose of AZD4205 along with carbamazepine after the wash-out period. | Drug | AZD4205 and carbamazepine |
| AZD4205 and itraconazoleAll subjects will receive AZD4205 single dose on Day 1, and the second dose of AZD4205 along with itraconazole after the wash-out period. | Drug | AZD4205 and itraconazole |
Primary outcome
Maximum plasma concentration (Cmax) of AZD4205 when dosed alone or coadministered with itraconazole (Part A)
Time frame: up to 10 days after study drug administration when AZD4205 dosed alone; up to 18 days after study drug administration when coadministered with itraconazole
Time to reach maximum plasma concentration (tmax) of AZD4205 when dosed alone or coadministered with itraconazole (Part A)
Time frame: up to 10 days after study drug administration when AZD4205 dosed alone; up to 18 days after study drug administration when coadministered with itraconazole
Area under the concentration-time curve from time 0 to time of last quantifiable concentration (AUC0-t) when dosed alone or coadministered with itraconazole (Part A)
Time frame: up to 10 days after study drug administration when AZD4205 dosed alone; up to 18 days after study drug administration when coadministered with itraconazole
Area under the concentration-time curve from time 0 to infinity (AUC0-inf) when dosed alone or coadministered with itraconazole (Part A)
Time frame: up to 10 days after study drug administration when AZD4205 dosed alone; up to 18 days after study drug administration when coadministered with itraconazole
Maximum plasma concentration (Cmax) of AZD4205 when dosed alone or coadministered with carbamazepine (Part B)
Time frame: up to 10 days after study drug administration
Time to reach maximum plasma concentration (tmax) of AZD4205 when dosed alone or coadministered with carbamazepine (Part B)
Time frame: up to 10 days after study drug administration
Area under the concentration-time curve from time 0 to time of last quantifiable concentration (AUC0-t) when dosed alone or coadministered with carbamazepine (Part B)
Time frame: up to 10 days after study drug administration
Area under the concentration-time curve from time 0 to infinity (AUC0-inf) when dosed alone or coadministered with carbamazepine (Part B)
Time frame: up to 10 days after study drug administration
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 1 Feb 2023.
- Individual participant dataSharing planned: No
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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.
Shirlian Xu study director
Dizal Pharma
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 AZD4205 and carbamazepine and AZD4205 and itraconazole in people with Healthy Subjects, run by Dizal Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 31 exclusion criteria. 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 1 Feb 2023. 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 United States. 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 concentration (Cmax) of AZD4205 when dosed alone or coadministered with itraconazole (Part A) (time frame: up to 10 days after study drug administration when AZD4205 dosed alone; up to 18 days after study drug administration when coadministered with itraconazole). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Feb 2023.