Surufatinib DDI With a PPI and a CYP3A Inducer

NCT04510649 | Completed Phase 1 FDA Drug

• 1 other identifier: 2020-012-00US1
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• 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

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

  up to 16 days

• AUC of Surufatinib

  Pharmacokinetics of surufatinib by assessment of area under the plasma concentration curve from zero extrapolated to infinity (if data permit)

  up to 16 days

• Cmax of Surufatinib

  Pharmacokinetics of Surufatinib by assessment of maximum plasma Surufatinib concentration

  up to 16 days

Secondary Outcomes (1)

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

  up to 16 days

Study Arms (2)

Surufatinib and Rabeprazole (Part A)

EXPERIMENTAL

Part A: Surufatinib 300 mg on study days 1 and 11 Rabeprazole 40 mg on study days 5 - 11

Drug: Part A

Surufatinib and Rifampin (Part B)

EXPERIMENTAL

Part B: Surufatinib 300 mg on study days 1 and 12 Rifampin 600 mg on study days 5-15

Drug: Part B

Interventions

Part A DRUG

in Part A, all subjects will receive Surufatinib 300 mg in a single dose on study days 1 and 11 and receive Rabeprazole 30 mg single dose on study days 5 through 11

Also known as: Rabeprazole 30 mg

Surufatinib and Rabeprazole (Part A)

Part B DRUG

in Part B, all subjects will receive Surufatinib 300 mg in a single dose on study days 1 and 12 and receive Rifampin 600 mg single dose on study days 5 through 16

Also known as: Rifampin 600 mg

Surufatinib and Rifampin (Part B)

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 (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.

You may not qualify if:

• 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, vital signs, or clinical laboratory determinations
• Systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg
• Clinically significant ECG abnormality, including a marked baseline prolongation of QT/QTc interval (eg, repeated demonstration of a QTcF interval \> 480 msec), or had a family history of prolonged QTc syndrome or sudden death
• Has Gilbert's syndrome as indicated by total bilirubin \> upper limit of normal (ULN) and subsequent measurement of direct bilirubin is not within normal range.
• History of smoking or use of nicotine-containing substances within the previous 2 months
• History of drug or alcohol misuse in the previous 6 months
• Diagnosed with acquired immune deficiency syndrome (AIDS) or has performed tests that are positive for human immunodeficiency virus (HIV), Hepatitis B virus (HBV), or Hepatitis C virus (HCV)
• Participated in a clinical trial of other drug and 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
• Consumes grapefruit, starfruit, Seville oranges, or their products within 7 days before first dose
• Consumes herbal preparations/medications, including, but not limited to kava, ephedra (ma huang), Ginkgo biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng within 7 days before first dose
• Weight loss or gain of \> 10% within 4 weeks before first dose

Sponsors & Collaborators

• Hutchison Medipharma Limited: lead

Study Sites (1)

West Coast Clinical Trials (WCCT)

Cypress, California, 90630, United States

Location

MeSH Terms

Interventions

Rabeprazole; Medicare Part B; Rifampin

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Medicare; Medical Assistance; Public Assistance; Financing, Government; Financing, Organized; Economics; Health Care Economics and Organizations; Insurance, Health; Insurance; Legislation as Topic; Social Control, Formal; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Youngiun Kim, MD

  WCCT Global Inc.

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: August 12, 2020
• Study Start: July 9, 2020
• Primary Completion: September 11, 2020
• Study Completion: March 2, 2021
• Last Updated: June 18, 2021

Record last verified: 2020-08

Locations

US (1)