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

Sponsor
Hutchison Medipharma Limited (Industry)
Overall Status
Completed
CT.gov ID
NCT03483259
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
1.5
Actual Duration (Months)
19.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Sulfatinib T capsule
  • Drug: Sulfatinib R capsule
 Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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) .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) .
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
To Explore the Pharmacokinetics and Relative Bioavailability of Sulfatinib Capsules in Two Different Manufacturers in Chinese Adult Male Healthy Volunteers
Actual Study Start Date :
Apr 2, 2018
Actual Primary Completion Date :
May 12, 2018
Actual Study Completion Date :
May 18, 2018

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The area under the plasma concentration-time curve (AUC) from 0 to the time of the last measurable concentration (AUCt) of Sulfatinib [Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5]

      The area under the plasma concentration-time curve (AUC) from 0 to the time of the last measurable concentration.

    2. Maximum observed plasma concentration (Cmax) of Sulfatinib [Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5]

      Maximum observed concentration, occurring at Tmax.

    3. The time to Cmax (peak time, Tmax) of Sulfatinib [Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5]

      The time at which maximum plasma concentration (Cmax) is observed.

    4. Half-life (t1/2) of Sulfatinib [Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5]

      The time required for the concentration of the drug to reach half of its original value.

    5. Relative Bioavailability [Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5]

      This term represents the relationship between the bioavailability of a substance in two different media.

    Secondary Outcome Measures

    1. Adverse Event (AE) monitoring of Sulfatinib [Measured from the date signed ICF to within 14 days after the last dose]

      AE monitoring will be assessed by incidence of AEs, AE grading, serious AEs, as well as laboratory determinations and vital sign parameters.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shanghai Xuhui District Central Hospital Shanghai Shanghai China 200031

    Sponsors and Collaborators

    • Hutchison Medipharma Limited

    Investigators

    • Principal Investigator: Liu Yanmei, Master, Shanghai Xuhui District Central Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hutchison Medipharma Limited
    ClinicalTrials.gov Identifier:
    NCT03483259
    Other Study ID Numbers:
    • 2016-012-00CH2
    First Posted:
    Mar 30, 2018
    Last Update Posted:
    Nov 13, 2018
    Last Verified:
    Nov 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hutchison Medipharma Limited
    Pharmacokinetics
    Relative bioavailability

    Study Results

    No Results Posted as of Nov 13, 2018