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CompletedNCT05486949Updated Feb 1, 2023

Drug-drug Interactions Between AZD4205 and Itraconazole/Carbamazepine

A Phase 1 interventional study of AZD4205 and carbamazepine and AZD4205 and itraconazole in Healthy Subjects, sponsored by Dizal Pharmaceuticals. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-01.

Sponsored by Dizal Pharmaceuticals · Phase 1, Interventional, and Other

From the registry’s dates

  • Primary completion was Oct 2022, 4 years ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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 carbamazepine, a CYP3A4 inducer, on the single dose PK of AZD4205 in healthy adult subjects (Part B).

02

Conditions studied

  • Healthy Subjects
03

In context

Lead sponsor

Dizal Pharmaceuticals is the lead sponsor of 37 studies on the registry; 15 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 1 (7%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Willing to participate in the study, give written informed consent, and comply with the study restrictions.
  2. Sex: male or female; females may be of childbearing potential, of nonchildbearing potential, or postmenopausal.
  3. Age: 18 to 55 years, inclusive, at screening.
  4. Body mass index (BMI): 18.0 to 30.0 kg/m2, inclusive, at screening.
  5. Weight: ≥55 kg for males and ≥45 kg for females at screening.
  6. Status: healthy subjects.
  7. Healthy status as defined by the absence of evidence of any clinically significant, in the opinion of the investigator, active, or chronic disease.
  8. 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.
  9. No clinically significant hematological or coagulation abnormalities, as judged by the investigator.
  10. 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.
  11. 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.
  12. 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.
  13. Normal baseline ECG (QTcF \<450 msec, PR \<220 msec).
  14. Adequate organ function, defined by the absence of any clinically significant abnormalities, as judged by the investigator, of the relevant baseline clinical safety assessments.

Exclusion criteria

Exclusion Criteria:

  1. Employee of PRA or the sponsor.
  2. 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.
  3. 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.
  4. For all females of childbearing potential: positive pregnancy test at screening or at admission to the clinic.
  5. 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.
  6. Use of any investigational drug or device within 30 days, or investigational biologics within 120 days before the first dose of study drug.
  7. Any disease which, in the opinion of the investigator, poses an unacceptable risk to the subject.
  8. Clinically relevant issues of visual function as determined from the medical history and physical exams, as judged by the investigator.
  9. Clinically significant history of any drug sensitivity, drug allergy, or food allergy, as determined by the investigator.
  10. 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.
  11. History of major surgery or blood transfusion within 30 days prior to the first drug administration.
  12. History of malignancy of any type.
  13. Evidence of clinically significant or relevant renal, hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease.
  14. Manifestation of malabsorption due to prior gastrointestinal surgery, gastrointestinal disease, or any other reason that may affect the absorption of AZD4205.
  15. Positive result from a COVID-19 test per site policy and requirement.
  16. Positive test result for alcohol and/or drugs of abuse at screening or on Day -1.
  17. Positive test result from Quantiferon-TB Gold test.
  18. Presence of pulmonary infections or other clinically significant active infection within 30 days of informed consent.
  19. Received COVID-19 vaccine or any live vaccine within 4 weeks prior to the first dose of the investigational medicinal product.
  20. Self-reported substance abuse within 12 months of screening.
  21. Using tobacco or nicotine products within 90 days prior to the first drug administration.
  22. Strenuous activity, sunbathing, and contact sports within 48 hours prior to admission to the clinical facility through follow-up.
  23. 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.
  24. Plasma or platelet donation within 7 days of dosing and through follow-up.
  25. History within the previous 12 months of alcohol consumption exceeding 2 standard drinks per day on average.
  26. Positive screening test for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, or HIV 1 and 2 antibodies.
  27. Consumption of any nutrients/foods known to modulate CYP450 enzyme activity within 7 days prior to administration of study drug and during the study.
  28. Abnormal echocardiogram (ECHO) at baseline, as judged by the investigator.
  29. History of allergy, severe adverse reaction, intolerance, or hypersensitivity to itraconazole or other azole antifungals, as determined by the investigator (Part A Only).
  30. 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).
  31. Individuals who have Asian ancestry (including those who have 1 or more Asian grandparent, Part B Only).
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    AZD4205 and carbamazepine

    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.

    Drug: AZD4205 and carbamazepine

  • Experimental
    AZD4205 and itraconazole

    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.

    Drug: AZD4205 and itraconazole

Interventions

  • DrugAZD4205 and carbamazepine

    All subjects will receive AZD4205 single dose on Day 1, and the second dose of AZD4205 along with carbamazepine after the wash-out period.

  • DrugAZD4205 and itraconazole

    All subjects will receive AZD4205 single dose on Day 1, and the second dose of AZD4205 along with itraconazole after the wash-out period.

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  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)

    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

  4. 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

  5. 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

  6. 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

  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)

    Time frame: 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)

    Time frame: up to 10 days after study drug administration

07

Study locations

1 site
  • Pharmaceutical Research Associates, Inc.
    Lenexa, Kansas 66219, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05486949
Lead sponsor
Dizal Pharmaceuticals
Responsible party
Sponsor
First posted
Aug 4, 2022
Start date
Jul 27, 2022
Primary completion
Oct 8, 2022
Completion
Oct 11, 2022
Last update
Feb 1, 2023

Study contacts

Shirlian Xu
study director · Dizal Pharma

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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