Relative Bioavailability of Early Phase and Late Phase Hetrombopag Olamine Formulations

NCT04688008 | Completed Phase 1

• 1 other identifier: SHR8735-112
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Bioavailability Study

Outcome Measures

Primary Outcomes (3)

• 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 (2)

• 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

Study Arms (2)

Treatment sequence #1

OTHER

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

Treatment sequence #2

OTHER

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

Interventions

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

Treatment sequence #1; Treatment sequence #2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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);

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

The Second Hospital of Anhui Medical University

Hefei, Anhui, China

Location

MeSH Terms

Interventions

hetrombopag

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: December 29, 2020
• Study Start: September 18, 2020
• Primary Completion: October 12, 2020
• Study Completion: October 30, 2020
• Last Updated: February 26, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)