Assessing the Effect of DZD9008 on the Pharmacokinetics of the Cocktail Probes Representative for CYP3A4, P-gp, BCRP and OATP1B1 in Patients with EGFR or HER2 Mutant Advanced Non-small Cell Lung Cancer (WU-KONG19)

PHASE1CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

July 31, 2023

Primary Completion Date

May 16, 2024

Study Completion Date

September 28, 2024

Conditions
Non-small Cell Lung Cancer
Interventions
DRUG

DZD9008 and Probe drugs (midazolam, digoxin, rosuvastatin)

Patients will receive single oral doses of probe drugs alone and after at least 27 days of treatment with DZD9008, 300 mg, once daily, until a treatment discontinuation criterion is met. Each patient will receive a single oral dose of DZD9008 on Day 7, and DZD9008 once daily for 27 days from Day 9 to Day 35. Patients will also receive a single oral dose of 2 mg midazolam on Day 1 and Day 32, and oral dose of 10 mg rosuvastatin and 0.25 mg digoxin cocktail on Day 2, Day 7 and Day 33.

Trial Locations (1)

250117

Shandong Cancer Hospital (Shandong Provincial Institute of Cancer Prevention and Treatment), Jinan

Sponsors
All Listed Sponsors
lead

Dizal Pharmaceuticals

INDUSTRY