To Explore the Pharmacokinetics and Relative Bioavailability of Sulfatinib Capsules in Two Different Manufacturers

NCT03483259 | Completed Phase 1

• 1 other identifier: 2016-012-00CH2
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Relative Bioavailability

Keywords

Pharmacokinetics; Relative bioavailability

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Adverse Event (AE) monitoring of Sulfatinib

  Measured from the date signed ICF to within 14 days after the last dose

Study Arms (2)

Arm A-Sulfatinib T capsule

EXPERIMENTAL

The subjects in this arm will receive sulfatinib T capsules from Hutchison Whampoa Pharmaceutical (Suzhou) Co., Ltd.

Drug: Sulfatinib T capsule

Arm B-Sulfatinib R capsule

EXPERIMENTAL

The subjects in this arm will receive sulfatinib R capsules from Beijing Yiling Bioengineering Technology Co., Ltd.

Drug: Sulfatinib R capsule

Interventions

Sulfatinib T capsule DRUG

Sulfatinib T capsules were produced by Hutchison Whampoa Pharmaceutical (Suzhou) Co., Ltd. production.

Also known as: HMPL-012, Surufatinib

Arm A-Sulfatinib T capsule

Sulfatinib R capsule DRUG

Sulfatinib R capsules were produced by Beijing Yiling Bioengineering Technology Co., Ltd.

Also known as: HMPL-012, Surufatinib

Arm B-Sulfatinib R capsule

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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;
• Previous gastrointestinal surgery, kidney surgery, cholecystectomy and surgery history may affect the absorption or excretion of drugs;
• Hypertension: systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg;
• Hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab) test positive, HIV or treponema pallidum antibodies test positive;
• Any drugs that may change the liver and kidney clearance;
• 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;
• 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;
• Any history of clinically serious disease or condition that the investigator believes may affect the outcome of this study.

Sponsors & Collaborators

• Hutchison Medipharma Limited: lead

Study Sites (1)

Shanghai Xuhui District Central Hospital

Shanghai, Shanghai Municipality, 200031, China

Location

MeSH Terms

Interventions

surufatinib

Study Officials

• Liu Yanmei, Master

  Shanghai Xuhui District Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Eligible subjects who did not meet the exclusion criteria were randomly assigned to one of the three groups: group A, B, and C (administration TRR, RTR and RRT, 9 subjects in each group, where T is the test formulation and R is the reference formulation) .

Study Record Dates

• First Submitted: March 8, 2018
• First Posted: March 30, 2018
• Study Start: April 2, 2018
• Primary Completion: May 12, 2018
• Study Completion: May 18, 2018
• Last Updated: November 13, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)