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Relative Bioavailability of Early Phase and Late Phase Hetrombopag Olamine Formulations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04688008
Recruitment Status : Completed
First Posted : December 29, 2020
Last Update Posted : February 26, 2021
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Study Description
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Brief Summary:
The primary objective of the study is to evaluate the relative bioavailability of early phase and late phase hetrombopag olamine formulations in healthy Chinese adult subjects under fasting conditions. The secondary objective of the study is to evaluate the safety of hetrombopag olamine in healthy Chinese adult subjects.

Condition or disease Intervention/treatment Phase
Bioavailability Study Drug: Hetrombopag Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Randomized, Single-dose, Two -Period, Crossover Study to Investigate the Relative Bioavailability of Early Phase and Late Phase Hetrombopag Olamine Formulations in Healthy Chinese Adult Subjects Under Fasting Conditions.
Actual Study Start Date : September 18, 2020
Actual Primary Completion Date : October 12, 2020
Actual Study Completion Date : October 30, 2020
Arms and Interventions
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Arm Intervention/treatment
Treatment sequence #1
29 of 58 subjects were given single oral dose of early phase hetrombopag olamine formulation in period 1 and late phase formulation in period 2
 Drug: Hetrombopag

Drug: Early phase hetrombopag olamine formulation single oral dose of 5 mg hetrombopag under fasting conditions

Drug: Late phase hetrombopag olamine formulation single oral dose of 5 mg hetrombopag under fasting conditions
Treatment sequence #2
29 of 58 subjects were given single oral dose of late phase hetrombopag olamine formulation in period 1 and early phase formulation in period 2
 Drug: Hetrombopag

Drug: Early phase hetrombopag olamine formulation single oral dose of 5 mg hetrombopag under fasting conditions

Drug: Late phase hetrombopag olamine formulation single oral dose of 5 mg hetrombopag under fasting conditions


Outcome Measures
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Primary Outcome Measures :
  1. Peak plasma concentration (Cmax) [ Time Frame: 0-120 hours post dose ]
  2. Area Under the plasma concentration vs time curve (AUC0-120). [ Time Frame: 0-120 hours post dose ]
  3. area under the blood concentration vs time curve (AUC0-inf). [ Time Frame: 0-infinity ]

Secondary Outcome Measures :
  1. Time to Reach Maximum Drug Concentration in Plasma After Single Dose (Tmax) [ Time Frame: 0-120 hours post dose ]
  2. Half-life Associated With the Terminal Slope (t½) [ Time Frame: 0-120 hours post dose ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
  2. Ability to complete the study as required by the protocol;
  3. Healthy male or female subjects aged 18 to 45 (including 18 and 45) at the date of signing the informed consent;
  4. Body mass index (BMI) within the range of 19 ~ 26 kg /m2 (including 19 and 26);

Exclusion Criteria:

  1. Allergic constitution;
  2. History of drug use, or drug abuse screening positive;
  3. Alcoholic or often drinkers;
  4. History of deep vein thrombosis, or any other thromboembolic event;
  5. A clear medical history of important primary organ diseases such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal system.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04688008


Locations
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China, Anhui
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
More Information
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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT04688008    
Other Study ID Numbers: SHR8735-112
First Posted: December 29, 2020    Key Record Dates
Last Update Posted: February 26, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No