Relative Bioavailability of Early Phase and Late Phase Hetrombopag Olamine Formulations

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.

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.

Study Overview

• Status: Completed
• Conditions: Bioavailability Study
• Intervention / Treatment: Drug: Hetrombopag

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China
      • The Second Hospital of Anhui Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2020
• Primary Completion (Actual): October 12, 2020
• Study Completion (Actual): October 30, 2020

Study Registration Dates

• First Submitted: December 11, 2020
• First Submitted That Met QC Criteria: December 24, 2020
• First Posted (Actual): December 29, 2020

Study Record Updates

• Last Update Posted (Actual): February 26, 2021
• Last Update Submitted That Met QC Criteria: February 24, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: SHR8735-112

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No