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Healthy SubjectsPhase 1NCT05418582

Drug-drug Interactions Between DZD9008 and Itraconazole/Carbamazepine

A Phase 1 study testing DZD9008 and intraconazole and DZD9008 and carbamazepine in people with Healthy Subjects, run by Dizal Pharmaceuticals at 1 site in United States.

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

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 DZD9008 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?
DZD9008 and intraconazole and DZD9008 and carbamazepine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
25 Jan 2022to 8 Dec 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

  • Healthy subjects aging 18 to 55 years with Body mass index (BMI) 18.0 to 30.0 kg/m2.
  • Weight : ≥ 55 kg for males and ≥ 45 kg for females.
  • Healthy status as defined by the absence of evidence of any clinically significant, in the opinion of the Investigator, active or chronic disease following a detailed medical and surgical history, a complete physical examination.
  • Ability and willingness to abstain from alcohol-, caffeine-, and methylxanthine-containing beverages or food during the stay in study center.
  • 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 method(s) of contraception and comply with pregnancy precautions.
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  • All nonregular medication (including over-the-counter [OTC] medication, health supplements, and herbal remedies such as St. John's wort extract) must have been stopped at least 14 days or 5 half-lives, if known (whichever is longer) prior to the admission to the clinical research center.
  • Normal baseline pulmonary function tests (≥ 80% predicted normal for spirometry, lung volumes).
  • Normal baseline ECG (QTcF < 450 msec, PR < 220 msec).
  • Adequate organ function including hepatic, renal, cardiac, and bone marrow function, as determined by the Investigator.

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 dosing of study drug.
  • For all females of childbearing potential: positive pregnancy test at screening and 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 dosing of study drug.
  • Use of any investigational drug or device within 30 days of 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 subjects.
  • 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 (such as anaphylaxis, hepatotoxicity, or treatment with steroids or epinephrine). Confirmatory circumstances would include treatment with epinephrine or in Emergency Department.
  • History of allergy or hypersensitivity to DZD9008, or other drugs similar in class (EGFR/HER2/BTK inhibitor) or similar in chemical structure to DZD9008, 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, except for the following: surgically excised non-melanomatous skin cancers more than 5 years prior to receiving the investigational medicinal product.
  • Evidence of clinically significant or relevant renal, hematological, endocrine, pulmonary, GI, cardiovascular, hepatic, psychiatric, neurological, or allergic disease, as judged by the Investigator.
  • Manifestation of malabsorption due to prior GI surgery, GI disease, or any other reason that may affect the absorption of DZD9008.
  • Positive result from a COVID-19 test per local policy and requirement.
  • Positive test result for alcohol and/or drugs of abuse at screening or on Day1.
  • 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 (eg, alcohol, licit, or illict drugs) 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 (2 days) 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 (1 standard drink=12 oz beer, 5 oz wine, and 1.5 oz spirits). Alcohol consumption will be prohibited 72 hours prior to admission to the clinical facility and until discharge in the last study period.
  • Positive screening test for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, or HIV 1 and 2 antibodies.
  • Consumption of any nutrients known to modulate CYP450 enzymes activity (eg, grapefruit or grapefruit juice, pomelo juice, star fruit, or Seville [blood] orange products) within 14 days prior to administration of study drug and during the study (until after discharge in the last study period).
  • Abnormal echocardiogram (ECHO) at baseline (eg, left ventricular ejection fraction [LVEF] < 50%), 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 (eg, oxcarbazepine), or other drugs that are structurally-related to carbamazepine, which include, but are not limited to tricyclic antidepressants (eg, amitriptyline, desipramine, imipramine, protriptyline, or nortriptyline), as judged by the Investigator. (Part B Only)
  • Individuals who have Asian ancestry (including those who have one or more Asian grandparents). (Part B Only)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Pharmaceutical Research Associates, Inc.

    Lenexa, Kansas, 66219

Other trials in United States

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 of DZD9008 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 DZD9008 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 DZD9008 in healthy adult subjects (Part B).

Being tested
DZD9008 and intraconazole, DZD9008 and carbamazepine

What participants receive

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

  • DZD9008 and intraconazoleDrug

    All subjects will receive DZD9008 single dose on Day 1, and the second dose of DZD9008 along with itraconazole after the wash-out period.

  • DZD9008 and carbamazepineDrug

    All subjects will receive DZD9008 single dose on Day 1, and the second dose of DZD9008 along with carbamazepine after the wash-out period.

Study groups in NCT05418582
Study groupRoleWhat they receive
DZD9008 and itraconazoleExperimentalSubjects in arm 1 will receive DZD9008 single dose on Day 1, and the second dose of DZD9008 along with itraconazole after the wash-out period.
Receives: Drug: DZD9008 and intraconazole
DZD9008 and carbamazepineExperimentalSubjects in arm 2 will receive DZD9008 single dose on Day 1, and the second dose of DZD9008 along with carbamazepine after the wash-out period.
Receives: Drug: DZD9008 and carbamazepine

What is being measured

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

  1. Maximum plasma concentration (Cmax) of DZD9008 when dosed alone or coadministered with itraconazole (Part A）

    Measured: up to 11 days after study drug administration

  2. Time to reach maximum plasma concentration (tmax) of DZD9008 when dosed alone or coadministered with itraconazole (Part A)

    Measured: up to 11 days after study drug administration

  3. 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 11 days after study drug administration

  4. 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 11 days after study drug administration

  5. Maximum plasma concentration (Cmax) of DZD9008 when dosed alone or coadministered with carbamazepine (Part B)

    Measured: up to 10 days after study drug administration

  6. Time to reach maximum plasma concentration (tmax) of DZD9008 when dosed alone or coadministered with carbamazepine (Part B)

    Measured: up to 10 days after study drug administration

  7. 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

  8. 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.

  1. First posted14 Jun 2022
  2. Study start25 Jan 2022
  3. Primary completion1 Jun 2022
  4. Study completion8 Dec 2022

Resources

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
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05418582
Sponsor's protocol ID
DZ2021E0008
Status last verified
Jun 2023
First submitted
28 May 2022
Last updated
23 Jun 2023
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DZD9008 and intraconazole and DZD9008 and carbamazepine 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 10 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 23 Jun 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 DZD9008 when dosed alone or coadministered with itraconazole (Part A） (time frame: up to 11 days after study drug administration). 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?

On the ClinicalTrials.gov record for NCT05418582.

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 23 Jun 2023.

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