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

Healthy Clinical Trial

Official title:

A Phase 1, Two Period Fixed-sequence Crossover Study to Assess the Effects of Itraconazole, a Strong CYP3A Inhibitor, on the Pharmacokinetics of Surufatinib in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04372407
• Other study ID #: 2019-012-00US2
• Status: Completed
• Phase: Phase 1
• Start date: July 9, 2020
• Est. completion date: January 19, 2021

Study information

• Verified date: July 2020
• Source: Hutchison Medipharma Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study will be a single center, open label, fixed-sequence crossover, 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: January 19, 2021
• Est. primary completion date: September 29, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

• 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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Surufatinib
Surufatinib: 200 mg as single dose on Days 1 and 9
• Itraconazole
Itraconazole: 200 mg BID on Day 5, then 200 mg QD on Days 6 to 14

Locations

Country	Name	City	State
United States	Covance Clinical Research Unit	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Hutchison Medipharma Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	AUC of Surufatinib	Pharmacokinetics of surufatinib by assessment of area under the plasma concentration curve from zero extrapolated to infinity	Up to Day 15
Primary	Cmax of Surufatinib	Pharmacokinetics of Surufatinib by assessment of maximum plasma Surufatinib concentration	Up to Day 15
Secondary	Number of participants with treatment emergent adverse events as assessed by CTCAE v5.0	To evaluate the safety, in healthy subjects, of a single dose of surufatinib administered with and without food	Up to Day 15