Surufatinib DDI With a PPI and a CYP3A Inducer

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Part A; Drug: Part B

• Registration Number: NCT04510649
• Lead Sponsor: Hutchison Medipharma Limited

Brief 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.

Detailed Description

This study will be a single center, open-label, 2 part, 2 period fixed-sequence crossover study to be conducted with 28 healthy male and female subjects (part A and part B). Subjects will be enrolled in either part A or part B.

In Part A, subjects will be administered surufatinib alone in treatment Period 1 and co-administered with rabeprazole in treatment Period 2.

In Part B, subjects will be administered surufatinib alone in treatment Period 1 and co-administered with rifampin in treatment Period 2.

PK samples will be collected through out both study periods.Subjects will be confined in the clinic from check-in on Day -1 through the end-of study visit on Day 15 (part A) and Day 16 (part B).

Study Timeline

• Study Start: 2020-07-09
• Status Verified: 2020-08
• Study First Submitted: 2020-08-10
• Study First Submitted QC: 2020-08-10
• Study First Posted: 2020-08-12
• Primary Completion: 2020-09-11
• Study Completion: 2021-03-02
• Last Update Submitted: 2021-06-16
• Last Update Posted: 2021-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Surufatinib and Rabeprazole (Part A)	Part A	Part A: Surufatinib 300 mg on study days 1 and 11 Rabeprazole 40 mg on study days 5 - 11
Surufatinib and Rifampin (Part B)	Part B	Part B: Surufatinib 300 mg on study days 1 and 12 Rifampin 600 mg on study days 5-15

Primary Outcome Measures

Name	Time	Method
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	up to 16 days	Pharmacokinetics of surufatinib by assessment of area under the plasma concentration time curve from zero to the last measurable concentration
AUC of Surufatinib	up to 16 days	Pharmacokinetics of surufatinib by assessment of area under the plasma concentration curve from zero extrapolated to infinity (if data permit)
Cmax of Surufatinib	up to 16 days	Pharmacokinetics of Surufatinib by assessment of maximum plasma Surufatinib concentration

Secondary Outcome Measures

Name	Time	Method
Number of participants with treatment emergent adverse events as assessed by CTCAE v5.0	up to 16 days	To evaluate the safety, in healthy subjects, of a single dose of 300 mg surufatinib administered alone and with rabeprazole or rifampin

Trial Locations

Locations (1)

West Coast Clinical Trials (WCCT); 🇺🇸 Cypress, California, United States