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CompletedNCT03483259CRC-C1721Updated Nov 13, 2018

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

A Phase 1 interventional study of Sulfatinib T capsule and Sulfatinib R capsule in Relative Bioavailability, sponsored by Hutchison Medipharma Limited. Completed at 1 site in China. Open to male participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2018-11-13.

Sponsored by Hutchison Medipharma Limited · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Male
01

Study summary

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

Read the 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.

02

Conditions studied

  • Relative Bioavailability

Keywords

  • Pharmacokinetics
  • Relative bioavailability
03

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
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

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.
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DrugSulfatinib T capsule

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

    Also known as: HMPL-012, Surufatinib

  • DrugSulfatinib R capsule

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

    Also known as: HMPL-012, Surufatinib

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5

  2. Maximum observed plasma concentration (Cmax) of Sulfatinib

    Maximum observed concentration, occurring at Tmax.

    Time frame: Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5

  3. The time to Cmax (peak time, Tmax) of Sulfatinib

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

    Time frame: Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5

  4. Half-life (t1/2) of Sulfatinib

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

    Time frame: Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5

  5. Relative Bioavailability

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

    Time frame: Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5

Secondary outcomes

  1. 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.

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

06

Study locations

1 site
  • Shanghai Xuhui District Central Hospital
    Shanghai, Shanghai 200031, China
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03483259
Lead sponsor
Hutchison Medipharma Limited
Responsible party
Sponsor
First posted
Mar 30, 2018
Start date
Apr 2, 2018
Primary completion
May 12, 2018
Completion
May 18, 2018
Last update
Nov 13, 2018

Study contacts

Liu Yanmei, Master
principal investigator · Shanghai Xuhui District Central Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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