A Study to Assess the Effect of a Strong CYP3A Inhibitor, on Surufatinib in Healthy Subjects (NCT04372407) | Clinical Trial Compass
CompletedPhase 1
A Study to Assess the Effect of a Strong CYP3A Inhibitor, on Surufatinib in Healthy Subjects
United States13 participantsStarted 2020-07-09
Plain-language summary
This study will be a 2-period study conducted with 14 healthy male or female subjects. Subjects will be administered surufatinib alone in Period 1 and in combination with itraconazole in Period 2.
Who can participate
Age range18 Years – 55 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Non-smoking, healthy male or female between the ages of 18 and 55 years old (inclusive).
* Body mass index (BMI) \> 18 and ≤ 29 kg/m2.
* Females must be of non-childbearing potential, or of childbearing potential and agree to use a medically acceptable method of contraception.
* Males who have not had a successful vasectomy and are partners of women of childbearing potential must use, or their partners must use, a highly effective method of contraception starting for at least one menstrual cycle prior to and throughout the entire study period, and for 2 weeks after the last dose of study drug. Those with partners using hormonal contraceptives must also use an additional approved method of contraception. No sperm donation is allowed during the study period and for 90 days after study drug discontinuation.
Exclusion Criteria:
* Evidence of clinically significant cardiovascular, hepatic, GI, renal, respiratory, endocrine, hematological, neurological, or psychiatric disease or abnormalities or had a known history of any GI surgery or cholecystectomy.
* Clinically significant illness within 8 weeks or had a clinically significant infection within 4 weeks prior to the first dose.
* Clinically significant deviation from normal in the physical examination, vital signs, or clinical laboratory determinations.
* Systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg.
* The subject has a clinically significant ECG abnormality, or had a family hi…