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A Study to Assess the Effect of a High Fat Meal on Surufatinib in Healthy Subjects

NCT04372394 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2021-05-24

No results posted yet for this study

Summary

This study will be a 2-period study conducted with 26 healthy male or female subjects. Subjects will be randomly assigned to either receive a single dose of surufatinib with food in period 1, then without food in period 2, or vice-versa.

Conditions

  • Healthy

Interventions

DRUG

surufatinib

Surufatinib: 300 mg as a single dose on Days 1 and 8 with or without food

Sponsors & Collaborators

  • Hutchison Medipharma Limited

    lead INDUSTRY

Principal Investigators

  • Jeanelle Kam, MD · Covance Clinical Research Unit

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-08-14
Primary Completion
2020-10-31
Completion
2021-03-02
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 NCT04372394 on ClinicalTrials.gov