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Drug-drug Interactions Between DZD9008 and Itraconazole/Carbamazepine

NCT05418582 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-06-23

No results posted yet for this 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 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).

Conditions

  • Healthy Subjects

Interventions

DRUG

DZD9008 and intraconazole

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

DRUG

DZD9008 and carbamazepine

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

Sponsors & Collaborators

  • Dizal Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Tianwei Zhang · Dizal Pharma

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-25
Primary Completion
2022-06-01
Completion
2022-12-08
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05418582 on ClinicalTrials.gov