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Phase 1Completed

Drug-drug Interactions Between DZD9008 and Itraconazole/Carbamazepine

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

Sponsor
Dizal Pharmaceuticals (Industry)
Enrollment
40 enrolled
Conditions
Healthy Subjects
Interventions
DZD9008 and intraconazole; DZD9008 and carbamazepine
Ages
adults
Registry
NCT05418582

Full record on ClinicalTrials.gov

From the registry

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).

Primary outcomes

  • Maximum plasma concentration (Cmax) of DZD9008 when dosed alone or coadministered with itraconazole (Part A）
  • Time to reach maximum plasma concentration (tmax) of DZD9008 when dosed alone or coadministered with itraconazole (Part A)
  • 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)
  • Area under the concentration-time curve from time 0 to infinity (AUC0-inf) when dosed alone or coadministered with itraconazole (Part A)

History

  1. Last registry update

  2. Study completion

  3. Registered

  4. Primary completion

  5. Started