A Study To Evaluate The Effect Of Rifampicin Or Ltraconazole On Pharmacokinetics Of Ensartinib In Healthy Volunteers

ConditionHealthy
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorBetta Pharmaceuticals Co., Ltd.

About this trial

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

Eligibility criteria

Qualifiers

Male body weight ≥ 50kg, female body weight ≥ 45kg, body mass index (BMI) within the range of 19 ~ 26kg /m2;

Clinical laboratory evaluations within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator;

The subjects should took effective contraceptive measures voluntarily from informed consent until 3 months after Study Completion;

Able to comprehend and willing to sign an informed consent form.

Disqualifiers

Those with a history of chronic systemic or serious diseases such as cardiovascular, liver, kidney, lung, gastrointestinal, nervous, musculoskeletal, hematopoietic or metabolic diseases, especially surgical conditions or conditions that may affect drug absorption, distribution, metabolism and excretion;

Family history or presence of long QTc syndrome; History or presence of an abnormal ECG;

Hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), treponema pallidum antibody or human immunodeficiency virus antigen/antibody (HIV-Ag/Ab) is positive;

Use of any medications (prescription drugs, over-the-counter drugs, Chinese herbal medicines, health products, moderate or strong CYP3A inhibitors or inducers, etc) within 14 days prior to the first administration;

Trial design

Treatments tested in this trial

  • Ensartinib
  • Rifampicin
  • Itraconazole
  • Ensartinib

Treatment groups

36 Participants
are divided into 2 treatment groups