Relative Bioavailability of Early Phase and Late Phase Hetrombopag Olamine Formulations

Sponsor

Jiangsu HengRui Medicine Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT04688008

Collaborator

(none)

Enrollment

Location

Arms

1.4

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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 :

Sep 18, 2020

Actual Primary Completion Date :

Oct 12, 2020

Actual Study Completion Date :

Oct 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: 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
Other: 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

Arm

Intervention/Treatment

Other: 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

Other: 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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

Allergic constitution;
History of drug use, or drug abuse screening positive;
Alcoholic or often drinkers;
History of deep vein thrombosis, or any other thromboembolic event;
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

Locations

	Site	City	State	Country	Postal Code
1	The Second Hospital of Anhui Medical University	Hefei	Anhui	China

Sponsors and Collaborators

Jiangsu HengRui Medicine Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jiangsu HengRui Medicine Co., Ltd.

ClinicalTrials.gov Identifier:

NCT04688008

Other Study ID Numbers:

SHR8735-112

First Posted:

Dec 29, 2020

Last Update Posted:

Feb 26, 2021

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Feb 26, 2021