HMPL-523 CYP3A/P-gp Inhibitor and CYP Inducer Study (NCT05720767) | Clinical Trial Compass
CompletedPhase 1
HMPL-523 CYP3A/P-gp Inhibitor and CYP Inducer Study
United States28 participantsStarted 2022-11-04
Plain-language summary
A Phase 1, Open-label, 2-Part, 2-Period Fixed-Sequence Crossover Study to Assess the Effect of Itraconazole, a CYP3A and P-glycoprotein Inhibitor, and the Effect of Rifampin, a CYP Enzyme Inducer, on the Pharmacokinetics of HMPL-523 in Healthy Volunteers
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion Criteria:
* 1\. The volunteer is male or female between the ages of 18 and 55 years old (inclusive) at the time of informed consent.
2\. The volunteer has a body mass index (BMI) \>18 and ≤29.9 kg/m2 at screening.
3\. Females must be postmenopausal (defined as absence of menses for at least one year without alternative medical cause) or permanently sterile by total hysterectomy, bilateral oophorectomy, or bilateral salpingectomy.
4\. Males, including those who have had a successful vasectomy, must use a condom during sexual intercourse with women of childbearing potential, starting from their first dose of study drug through 30 days after their last dose of study drug. Alternatively, abstinence is allowed if it is the normal and preferred lifestyle of the volunteer.
5\. The volunteer must provide written informed consent prior to any study specific screening procedures.
6\. The volunteer is willing and able to comply with all aspects of the protocol, as determined by the PI.
7\. The volunteer must have normal laboratory results for total bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT); creatinine clearance must be \> 90 mL/min estimated using the Cockcroft-Gault equation.
Exclusion Criteria:
* 1\. The volunteer has a known history of any gastrointestinal surgery or any condition possibly affecting drug absorption (eg, cholecystectomy, gastrectomy, achlorhydria, peptic ulcer disease, or history of stomach or intest…