A Clinical Study to Access the Pharmacokinetics of HMS5552 in Hepatic Impaired Subjects and Healthy Volunteers

NCT04426708 | Completed Phase 1

• 1 other identifier: HMM0109
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this study is to access the pharmacokinetics and safety of HMS5552 in single dose in mild and moderate hepatic impaired subjects and matched healthy adult subjects.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

• The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of Cmax;

  Plasma will be collected at predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hour post-dose.

  Up to 72 hours post-dose

• The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of AUClast;

  Plasma will be collected at predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hour post-dose.

  Up to 72 hours post-dose

• The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of AUCinf;

  Plasma will be collected at predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hour post-dose.

  Up to 72 hours post-dose

Secondary Outcomes (8)

• The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of Cmax,u

  Up to 72 hours post-dose

• The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of AUClast,u

  Up to 72 hours post-dose

• The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of AUCinf,u

  Up to 72 hours post-dose

• The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of Tmax ;

  Up to 72 hours post-dose

• The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of T1/2;

  Up to 72 hours post-dose

Study Arms (3)

Mild hepatic impaired subjects (A)

EXPERIMENTAL

Mild hepatic impaired subjects: to receive a single dose of HMS5552 ( 25mg ) tablet orally

Drug: HMS5552

Moderate hepatic impaired subjects (B)

EXPERIMENTAL

Moderate hepatic impaired subjects: to receive a single dose of HMS5552 ( 25mg ) tablet orally

Drug: HMS5552

Healthy volunteers (C)

EXPERIMENTAL

Matched healthy volunteers: to receive a single dose of HMS5552 ( 25mg ) tablet orally

Drug: HMS5552

Interventions

HMS5552 DRUG

single dose of HMS5552 25mg

Healthy volunteers (C); Mild hepatic impaired subjects (A); Moderate hepatic impaired subjects (B)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For hepatic impaired subjects:
• Male and female subjects between ages of 18 and 65 years, no less than 3 subjects in each gender.
• Body weight≥50kg for male and ≥45kg for female； BMI: 18.5\~30 kg/m2
• ALT\>2×normal upper limit (ULN), or TBiL\>1.5×ULN, or diagnosed cirrhosis. The related clinical manifestations have been stable for 4-12 weeks, and Child-Pugh score is in grade A or B:
• A= mild liver damage (Group A): Child-Pugh 5-6; B= moderate liver damage (Group B): Child-Pugh 7-9;
• Willing to sign the informed consent form (ICF) and take reliable contraceptive measures within 6 months after taking the last dose of study drug;
• Willing to adhere to the protocol requirement.
• For healthy volunteers:
• Male and female subjects between ages of 18 and 65 years, no less than 3 subjects in each gender;
• Body weight≥50kg for male and ≥45kg for female； BMI: 18.5\~30 kg/m2;
• Gender, age (±5 years) and BMI (±15%) matched with corresponding subject in hepatic impaired group;
• Normal physical conditions, vital signs,12 lead ECG and laboratory recording;
• Willing to sign the informed consent form (ICF) and take reliable contraceptive measures within 6 months after taking the last dose of study drug;
• Willing to adhere to the protocol requirement.

You may not qualify if:

• Subjects with impaired hepatic function cannot be enrolled if they meet one of the following criteria:
• Liver cancer, liver transplantation, liver failure, autoimmune liver disease, biliary cirrhosis, or drug-induced liver damage;
• History of allergy;
• Investigators adjudicate subjects have surgery that may affect drug absorption, distribution, metabolism or excretion;
• In addition to diseases and complications of impaired hepatic function, investigator adjudicate subjects have clinically meaningful or unstable diseases or complications of central nervous system, cardiovascular system, digestive system, endocrine system, respiratory system, urinary system, blood system, mental disease, or malignant tumor, etc;
• Abnormal of ECG performance or laboratory recording during screening;
• Family history of QT prolongation syndrome;
• History of hepatic encephalopathy or hepatic coma within 6 months before screening;
• More than 5 cigarettes per day within 3 months before screening;
• Alcohol addicts;
• History of drug abuse
• Healthy subjects cannot be enrolled if they meet one of the following criteria:
• History of allergy;
• Investigators adjudicate subjects have surgery that may affect drug absorption, distribution, metabolism or excretion;
• Investigator adjudicate subjects have clinically meaningful or unstable diseases or complications of central nervous system, cardiovascular system, digestive system, endocrine system, respiratory system, urinary system, blood system, mental disease, or malignant tumor, etc;

Sponsors & Collaborators

• Hua Medicine Limited: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610000, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Dorzagliatin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

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

Study Record Dates

• First Submitted: June 8, 2020
• First Posted: June 11, 2020
• Study Start: February 18, 2019
• Primary Completion: July 3, 2020
• Study Completion: July 3, 2020
• Last Updated: November 29, 2022

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)