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

NCT04372394 | Completed Phase 1 FDA Drug

• 1 other identifier: 2019-012-00US1
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• AUC (0-t) of Surufatinib

  Pharmacokinetics of surufatinib by assessment of area under the plasma concentration time curve from zero to the last measurable concentration

  Up to Day 15

• AUC of Surufatinib

  Pharmacokinetics of surufatinib by assessment of area under the plasma concentration curve from zero extrapolated to infinity

  Up to Day 15

• Cmax of Surufatinib

  Pharmacokinetics of Surufatinib by assessment of maximum plasma Surufatinib concentration

  Up to Day 15

Secondary Outcomes (1)

• Number of participants with treatment emergent adverse events as assessed by CTCAE v5.0

  Up to Day 15

Study Arms (2)

Fed/Fasted

EXPERIMENTAL

surufatinib with food on Day 1 and surufatinib without food on Day 8

Drug: surufatinib

Fasted/Fed

EXPERIMENTAL

surufatinib without food on Day 1 and surufatinib with food on Day 8

Drug: surufatinib

Interventions

surufatinib DRUG

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

Fasted/Fed; Fed/Fasted

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Known food allergy to any content of the standard meal to be used in this study.
• 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 history of prolonged QTc syndrome or sudden death.
• A history of smoking or use of nicotine-containing substances within the previous 2 months.
• A history of drug or alcohol misuse in the previous 6 months.
• Has been diagnosed with acquired immune deficiency syndrome (AIDS) or are positive for human immunodeficiency virus (HIV), Hepatitis B virus (HBV), or Hepatitis C virus (HCV).
• Has participated in a clinical trial of other drug before screening, and the time since the last use of other study drug is less than 5 times the half- life or 4 weeks, whichever is longer, or the subject is currently enrolled in another clinical trial.
• Has received blood or blood products within 4 weeks, or donated blood or blood products within 8 weeks.
• Has used any over-the-counter (OTC) medications or prescription drugs within 2 weeks.

Sponsors & Collaborators

• Hutchison Medipharma Limited: lead

Study Sites (1)

Covance Clinical Research Unit

Dallas, Texas, 75247, United States

Location

MeSH Terms

Interventions

surufatinib

Study Officials

• Jeanelle Kam, MD

  Covance Clinical Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be randomly assigned to 1 of the 2 possible treatment sequences as follows: * Fed/Fasted: surufatinib with food on Day 1 and surufatinib without food on Day 8 * Fasting/Fed: surufatinib without food on Day 1 and surufatinib with food on Day 8

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: May 4, 2020
• Study Start: August 14, 2020
• Primary Completion: October 31, 2020
• Study Completion: March 2, 2021
• Last Updated: May 24, 2021

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)