Relative Bioavailability and Pharmacodynamics of HSK7653 in Healthy Volunteers

NCT06003088 | Completed Phase 1

• 1 other identifier: HSK7653-105
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the relative bioavailability of HSK7653(5mg) given as formulation A versus formulation B. To investigate the relative bioavailability of HSK7653(25mg) given as formulation A versus formulation B. To investigate safety and pharmacodynamics of two doses of HSK7653 in healthy male subjects.

Conditions

Healthy

Outcome Measures

Primary Outcomes (9)

• Relative bioavailability (F)

  To Evaluate Relative Bioavailability (F) of Two Doses of HSK7653 in Healthy Volunteers. Relative bioavailability of HSK7653(5mg) given as formulation A versus formulation B=AUC(0-t)(HSK7653(5mg) Formulation A)/AUC(0-t)(HSK7653(5mg) Formulation B). Relative bioavailability of HSK7653(25mg) given as formulation A versus formulation B=AUC(0-t)(HSK7653(25mg) Formulation A)/AUC(0-t)(HSK7653(25mg) Formulation B).

  Pre-dose，0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168 and 336 hours post-dose.

• AUC(0-t)

  The pharmacokinetic parameters of HSK7653 in plasma

  Pre-dose，0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168 and 336 hours post-dose.

• AUC(0-∞)

  The pharmacokinetic parameters of HSK7653 in plasma

  Pre-dose，0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168 and 336 hours post-dose.

• Cmax

  The pharmacokinetic parameters of HSK7653 in plasma

  Pre-dose，0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168 and 336 hours post-dose.

• Tmax

  The pharmacokinetic parameters of HSK7653 in plasma

  Pre-dose，0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168 and 336 hours post-dose.

• t1/2

  The pharmacokinetic parameters of HSK7653 in plasma

  Pre-dose，0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168 and 336 hours post-dose.

• λz

  The pharmacokinetic parameters of HSK7653 in plasma

  Pre-dose，0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168 and 336 hours post-dose.

• Vd/F

  The pharmacokinetic parameters of HSK7653 in plasma

  Pre-dose，0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168 and 336 hours post-dose.

• CL/F

  The pharmacokinetic parameters of HSK7653 in plasma

  Pre-dose，0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168 and 336 hours post-dose.

Secondary Outcomes (5)

• The Safety of HSK7653

  From First dose until Follow up visit, assessed up to 3 months.

• AUEC(0-last)

  Pre-dose，0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168 and 336 hours post-dose.

• ECmax

  Pre-dose，0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168 and 336 hours post-dose.

• ETmax

  Pre-dose，0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168 and 336 hours post-dose.

• DPP-4(WAI-2W)

  Pre-dose，0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168 and 336 hours post-dose.

Study Arms (4)

HSK7653(5mg) Sequence A(Formulation A + Formulation B)

EXPERIMENTAL

Participants will receive a single oral dose of treatment 1: Formulation A followed by a washout period of at least 36 days from first dose of HSK7653(5mg). After the washout period, participants will receive a single oral dose of Treatment 2: HSK7653(5mg) Formulation B.

Drug: HSK7653(5mg)

HSK7653(5mg) Sequence B(Formulation B + Formulation A)

EXPERIMENTAL

Participants will receive a single oral dose of treatment 1: Formulation B followed by a washout period of at least 36 days from first dose of HSK7653(5mg). After the washout period, participants will receive a single oral dose of Treatment 2: HSK7653(5mg) Formulation A.

Drug: HSK7653(5mg)

HSK7653(25mg) Sequence A(Formulation A + Formulation B)

EXPERIMENTAL

Participants will receive a single oral dose of treatment 1: Formulation A followed by a washout period of at least 36 days from first dose of HSK7653(25mg). After the washout period, participants will receive a single oral dose of Treatment 2: HSK7653(25mg) Formulation B.

Drug: HSK7653(25mg)

HSK7653(25mg) Sequence B(Formulation B + Formulation A)

EXPERIMENTAL

Participants will receive a single oral dose of treatment 1: Formulation B followed by a washout period of at least 36 days from first dose of HSK7653(25mg). After the washout period, participants will receive a single oral dose of Treatment 2: HSK7653(25mg) Formulation A.

Drug: HSK7653(25mg)

Interventions

HSK7653(5mg) DRUG

Participants will receive a single oral dose of HSK7653(5mg) Formulation A Or a single oral dose of HSK7653(5mg) Formulation B on Day 1 Period 1. Depending on what Formulation was received on Day 1 Period 1, participants will receive either a single oral dose of HSK7653(5mg) Formulation A Or a single oral dose of HSK7653(5mg) Formulation B on Day 1 of Period 2. Each period lasts for 15 days.

Also known as: HSK7653

HSK7653(5mg) Sequence A(Formulation A + Formulation B); HSK7653(5mg) Sequence B(Formulation B + Formulation A)

HSK7653(25mg) DRUG

Participants will receive a single oral dose of HSK7653(25mg) Formulation A Or a single oral dose of HSK7653(25mg) Formulation B on Day 1 Period 1. Depending on what Formulation was received on Day 1 Period 1, participants will receive either a single oral dose of HSK7653(25mg) Formulation A Or a single oral dose of HSK7653(25mg) Formulation B on Day 1 of Period 2. Each period lasts for 15 days.

Also known as: HSK7653

HSK7653(25mg) Sequence A(Formulation A + Formulation B); HSK7653(25mg) Sequence B(Formulation B + Formulation A)

Eligibility Criteria

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

You may qualify if:

• Healthy male and female subjects, age ≥18 years old，with appropriate sex ratio；
• A total body weight ≥40 kg for females and ≥50 kg for males；BMI of 19 to 26 kg/m\^2(inclusive);
• Subjects(and their partners) volunteered to use effective physical contraception, had no plans to have children or donate sperm/eggs from 14 days before the first dose to 6 months after the last dose;
• Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.

You may not qualify if:

• Subjects who are allergic to two or more medicine, foods or pollens or have a history of allergy to the investigational product and the related compounds;
• Have a history of severe unconscious hypoglycemia；
• Clinical evidence or history of any of the following diseases:
• Inflammatory bowel disease, gastritis, ulcers, bile duct stones, or gastrointestinal bleeding
• Major gastrointestinal surgery (e.g., gastrectomy, gastrostomy, or enterectomy)
• Pancreatic injury or pancreatitis
• Abnormal liver function tests (such as ALT, AST, serum bilirubin) , indicating liver disease or liver injury
• Renal insufficiency
• Urinary tract obstruction or difficulty in bladder emptying;
• Evidence or history of chronic or serious diseases of the blood system, circulatory system, digestive system, urinary system, respiratory system, nervous system, immune system, endocrine system, mental disorders, metabolic disorders, or any other diseases that may affect the results of the study;
• Serious trauma and surgery within 3 month prior to Screening;
• Use of vaccines within 1 month prior to dosing;
• Use of prescription within 1 month prior to dosing，or use of nonprescription drugs（i.e. vitamins and herbal medicines）within 14 days prior to dosing;
• Participation in another trial with an investigational drug or instrument within 3 months prior to dosing and for the duration of the study;
• History of regular alcohol consumption exceeding 14 drinks/week (1 drink = 150 mL of wine or 360 mL of beer or 45 mL of hard liquor) within 6 months of Screening.

Sponsors & Collaborators

• Haisco Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Shenyang, Liaoning, China

Location

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: January 11, 2023
• First Posted: August 21, 2023
• Study Start: June 15, 2022
• Primary Completion: August 12, 2022
• Study Completion: September 9, 2022
• Last Updated: August 24, 2023

Record last verified: 2023-08

Locations

CN (1)