A Study To Evaluate The Effect Of Rifampicin Or Ltraconazole On Pharmacokinetics Of Ensartinib In Healthy Volunteers
NCT Number: NCT06492525
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy
Interventions: DRUG: Ensartinib|DRUG: Rifampicin|DRUG: Itraconazole|DRUG: Ensartinib
Sponsor: Betta Pharmaceuticals Co., Ltd.
Sex: ALL
Age: ADULT
Enrollment: 36
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-07
Completion Date: 2024-12
Locations: The Second Affiliated hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310009, China

Summary:
The purpose of this study is to estimate the effect of rifampicin or itraconazole on the single dose PK of ensartinib.

Primary Outcome Measures: Plasma AUC0-t for Ensartinib Given Alone and With Rifampicin, AUC0-t is the plasma area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (Clast)., Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose on Day 1 after Ensartinib 225 mg administration in Period 1, and at the same time points on Day 18 after Ensartinib 225 mg with rifampin administration in Period 2.|Plasma AUC0-t for Ensartinib Given Alone and With Itraconazole, AUC0-t is the plasma area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (Clast)., Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 hours post-dose on Day 1 after Ensartinib 100 mg administration in Period 1, and at the same time points on Day 12 after Ensartinib 100 mg with Itraconazole administration in Period 2.|Plasma AUC0-∞ for Ensartinib Given Alone and With Rifampicin, AUC0-∞ is the plasma area under the plasma concentration-time profile from time 0 extrapolated to infinite time., Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose on Day 1 after Ensartinib 225 mg administration in Period 1, and at the same time points on Day 18 after Ensartinib 225 mg with rifampin administration in Period 2.|Plasma AUC0-∞ for Ensartinib Given Alone and With Itraconazole, AUC0-∞ is the plasma area under the plasma concentration-time profile from time 0 extrapolated to infinite time., Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 hours post-dose on Day 1 after Ensartinib 100 mg administration in Period 1, and at the same time points on Day 12 after Ensartinib 100 mg with Itraconazole administration in Period 2.|Plasma Cmax for Ensartinib Given Alone and With Rifampicin, Maximum plasma concentration, Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose on Day 1 after Ensartinib 225 mg administration in Period 1, and at the same time points on Day 18 after Ensartinib 225 mg with rifampin administration in Period 2.|Plasma Cmax for Ensartinib Given Alone and With Itraconazole, Maximum plasma concentration, Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 hours post-dose on Day 1 after Ensartinib 100 mg administration in Period 1, and at the same time points on Day 12 after Ensartinib 100 mg with Itraconazole administration in Period 2.