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A Study to Assess the Effect of a Strong CYP3A Inhibitor, on Surufatinib in Healthy Subjects

NCT04372407 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2021-02-03

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

Surufatinib

Surufatinib: 200 mg as single dose on Days 1 and 9

DRUG

Itraconazole

Itraconazole: 200 mg BID on Day 5, then 200 mg QD on Days 6 to 14

Sponsors & Collaborators

  • Hutchison Medipharma Limited

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-09
Primary Completion
2020-09-29
Completion
2021-01-19
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04372407 on ClinicalTrials.gov