To Explore the Pharmacokinetics and Relative Bioavailability of Sulfatinib Capsules in Two Different Manufacturers (CRC-C1721)

To Explore the Pharmacokinetics and Relative Bioavailability of Sulfatinib Capsules in Two Different Manufacturers in Chinese Adult Male Healthy Volunteers

This is a single-center, randomized, open, single-dose, three-cycle cross-design study, which will be only enrolled Chinese male healthy volunteers.

Study Overview

• Status: Completed
• Conditions: Relative Bioavailability
• Intervention / Treatment: Drug: Sulfatinib T capsule; Drug: Sulfatinib R capsule

Detailed Description

27-30 Chinese male healthy volunteers will be enrolled to assess the pharmacokinetic profile and relative bioavailability of 300 mg (50 mg x 6) Sulfatinib capsules of single dose orally in two different manufacturers after breakfast. All subjects are required to collect PK blood samples before and after administration at the following time points: within 1 hour before administration, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48, 72, 96 hours after administration (16 times point), each collection of venous blood is 2mL.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200031
      • Shanghai Xuhui District Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Subjects must be voluntary and sign an informed consent form and agree to comply with the requirements of the protocol；
2. Age of 18-40 (inclusive), male healthy volunteers；
3. Medical history, physical examination, 12-lead ECG and laboratory tests at screening judged as normal or abnormal but not clinically significant by investigators;
4. Medical history, physical examination, 12-lead ECG and laboratory tests at screening judged as normal or abnormal but not clinically significant by investigators;
5. Men whose partners are women of childbearing potential are required to use adequate contraceptive methods during participation in this study；

Exclusion Criteria:

1. Any clinically significant disease or condition includes but not limited to metabolism/endocrine, liver, kidney, blood, lung, immune, cardiovascular, gastrointestinal, genito-urinary, nervous, or mental illness that judged by the investigator within 3 months before screening;
2. Previous gastrointestinal surgery, kidney surgery, cholecystectomy and surgery history may affect the absorption or excretion of drugs;
3. Hypertension: systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg;
4. Hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab) test positive, HIV or treponema pallidum antibodies test positive;
5. Any drugs that may change the liver and kidney clearance;
6. Take any prescription drug (including Chinese herbal medicine) within 14 days before dosing; or use any over-the-counter drugs (including but not limited to vitamins, prophylaxis, plant health products) within 7 days before dosing;
7. Clinical trials of other medications before screening, less than a 5-fold half-life or 28 days from the time of the last other study drug, whichever is longer;
8. Any history of clinically serious disease or condition that the investigator believes may affect the outcome of this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Arm A-Sulfatinib T capsule; The subjects in this arm will receive sulfatinib T capsules from Hutchison Whampoa Pharmaceutical (Suzhou) Co., Ltd.	Drug: Sulfatinib T capsule; Sulfatinib T capsules were produced by Hutchison Whampoa Pharmaceutical (Suzhou) Co., Ltd. production.; Other Names: HMPL-012, Surufatinib
EXPERIMENTAL: Arm B-Sulfatinib R capsule; The subjects in this arm will receive sulfatinib R capsules from Beijing Yiling Bioengineering Technology Co., Ltd.	Drug: Sulfatinib R capsule; Sulfatinib R capsules were produced by Beijing Yiling Bioengineering Technology Co., Ltd.; Other Names: HMPL-012, Surufatinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The area under the plasma concentration-time curve (AUC) from 0 to the time of the last measurable concentration (AUCt) of Sulfatinib	The area under the plasma concentration-time curve (AUC) from 0 to the time of the last measurable concentration.	Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5
Maximum observed plasma concentration (Cmax) of Sulfatinib	Maximum observed concentration, occurring at Tmax.	Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5
The time to Cmax (peak time, Tmax) of Sulfatinib	The time at which maximum plasma concentration (Cmax) is observed.	Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5
Half-life (t1/2) of Sulfatinib	The time required for the concentration of the drug to reach half of its original value.	Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5
Relative Bioavailability	This term represents the relationship between the bioavailability of a substance in two different media.	Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Event (AE) monitoring of Sulfatinib	AE monitoring will be assessed by incidence of AEs, AE grading, serious AEs, as well as laboratory determinations and vital sign parameters.	Measured from the date signed ICF to within 14 days after the last dose

Collaborators and Investigators

• Sponsor: Hutchison Medipharma Limited
• Investigators: Principal Investigator: Liu Yanmei, Master, Shanghai Xuhui District Central Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 2, 2018
• Primary Completion (ACTUAL): May 12, 2018
• Study Completion (ACTUAL): May 18, 2018

Study Registration Dates

• First Submitted: March 8, 2018
• First Submitted That Met QC Criteria: March 23, 2018
• First Posted (ACTUAL): March 30, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 13, 2018
• Last Update Submitted That Met QC Criteria: November 8, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Relative bioavailability
• Other Study ID Numbers: 2016-012-00CH2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No