Surufatinib DDI With a PPI and a CYP3A Inducer (NCT04510649) | Clinical Trial Compass
CompletedPhase 1
Surufatinib DDI With a PPI and a CYP3A Inducer
United States28 participantsStarted 2020-07-09
Plain-language summary
The purpose of this is to evaluate the effect of proton pump inhibitor (rabeprazole) and the effect of a CYP3A inducer (rifampin) on the pharmacokinetics of Surufatinib.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion Criteria
* Non-smoking, healthy male or female between the ages of 18 and 55 years (inclusive)
* Body mass index (BMI) \> 18 and ≤ 29 kg/m2
* Females must be of non-childbearing potential or surgically sterile
* 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. Those with partners using hormonal contraceptives must also use an additional approved method of contraception such as a condom with spermicide. Males who have had a successful vasectomy (confirmed azoospermia, documentation needed) require no additional 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
* Known history of any GI surgery or any condition possibly affecting drug absorption, however appendectomy and hernia repair will be allowed
* Clinically significant illness within 8 weeks or a clinically significant infection within 4 weeks prior to first dose
* Known food allergy deemed clinically significant.
* Clinically significant deviation from normal in the physical examination, vit…
What they're measuring
1
AUC (0-t) of Surufatinib [ Time Frame: Up to Day 15 ] Pharmacokinetics of surufatinib by assessment of area under the plasma concentration time curve from zero to the last measurable concentration