Relative Bioavailability of Early Phase and Late Phase Hetrombopag Olamine Formulations

NCT04688008 — Phase 1, Completed, 58 participants, Jiangsu HengRui Medicine Co., Ltd.

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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.

Registry	NCT04688008
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, crossover, masking: none, treatment
Enrollment	58 (Actual)
Sponsor	Jiangsu HengRui Medicine Co., Ltd. (Industry)
Conditions	Bioavailability Study
Interventions	Hetrombopag (Drug)
Dates	start 2020-09-18, primary completion 2020-10-12, completion 2020-10-30, first posted 2020-12-29, last updated 2021-02-26
Locations	1 site in China

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Treatment sequence #1	Other	Drug: Hetrombopag	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
Treatment sequence #2	Other	Drug: Hetrombopag	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

Hetrombopag (Drug): 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

Primary outcomes

Peak plasma concentration (Cmax) [0-120 hours post dose]
Area Under the plasma concentration vs time curve (AUC0-120). [0-120 hours post dose]
area under the blood concentration vs time curve (AUC0-inf). [0-infinity]

Secondary outcomes

Time to Reach Maximum Drug Concentration in Plasma After Single Dose (Tmax) [0-120 hours post dose]
Half-life Associated With the Terminal Slope (t½) [0-120 hours post dose]

+Eligibility

Sex: All, ages: 18 Years to 45 Years, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
The Second Hospital of Anhui Medical University	Hefei, Anhui	China