US company started Fruquintinib Food Effect and Proton Pump Inhibitor Study
Hutchison Medipharma Limited is recruiting patients for the clinical trial of Fruquintinib Food Effect and Proton Pump Inhibitor.
The purpose of this study is to evaluate the effect of food and the effect of a proton pump inhibitor (rabeprazole) on the pharmacokinetics of fruquintinib.
Among primary outcome measures are AUC(0-t) of fruquintinib: area under the plasma-concentration time curve from time 0 to time of the last measurable concentration, AUC(0-inf) of fruquintinib and Cmax of fruquintinib.
Volunteers must meet the following criteria:
- Non-smoking, healthy male or female between the ages of 18 and 55 years (inclusive) at the time of informed consent.
- Body mass index (BMI) > 18 and ≤ 29 kg/m2.
- Females must be of non-childbearing potential (eg, postmenopausal or surgically sterile by total hysterectomy, bilateral oophorectomy, or bilateral tubal ligation).
- Males who have not had a successful vasectomy and are partners of women of childbearing potential must use, or their partners must use, a medically acceptable method of contraception starting for at least 1 menstrual cycle prior to and throughout the entire study period, and for 2 weeks after the last dose of study drug.
The study will take place at the WCCT, Cypress, California, United States.
The page dedicated to this clinical trial can be found here: https://ichgcp.net/clinical-trials-registry/NCT04645940
