Study to Assess Relative Bioavailability of GP681 Formulations in Healthy Chinese Male Subjects

NCT06678542 | Completed Phase 1

• 1 other identifier: 2024-GP681-S-BA/CRC-C2413
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to evaluate the relative bioavailability and pharmacokinetic profile of a single oral dose of the test formulation, GP681 Powder for Oral Suspension (20 mg/sachet), compared to the reference formulation, GP681 tablet (20 mg/tablet), in healthy Chinese male subjects. The secondary objectives are to assess the safety of a single oral dose of the GP681 Powder for Oral Suspension (20 mg/sachet) and GP681 tablet (20 mg/tablet) in healthy Chinese male subjects, as well as the palatability (taste acceptability) of the GP681 Powder for Oral Suspension.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (3)

• Maximum observed plasma concentration (Cmax)

  Up to 360 hours post-dose

• Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration[AUC(0-T)]

  Up to 360 hours post-dose

• Area under the plasma concentration-time curve from time zero extrapolated to infinite time[AUC(INF)]

  Up to 360 hours post-dose

Secondary Outcomes (9)

• Time of maximum observed concentration(Tmax)

  Up to 360 hours post-dose

• Apparent terminal half-life (T-HALF)

  Up to 360 hours post-dose

• Incidence of adverse events (AEs)

  Up to approximately 1 month post-dose

• Incidence of serious adverse events (SAEs)

  Up to approximately 1 month post-dose

• Incidence of participants with vital sign abnormalities

  Up to approximately 1 month post-dose

Study Arms (2)

Treatment sequence T-R

EXPERIMENTAL

Drug: GP681 tablet; Drug: GP681 Powder for Oral Suspension

Treatment sequence R-T

EXPERIMENTAL

Drug: GP681 tablet; Drug: GP681 Powder for Oral Suspension

Interventions

GP681 tablet DRUG

GP681 tablet, 20 mg, single oral dose in each Group.

Also known as: Reference treatment

Treatment sequence R-T; Treatment sequence T-R

GP681 Powder for Oral Suspension DRUG

GP681 Powder for Oral Suspension, 20 mg, single oral dose in each Group.

Also known as: Test Treatment

Treatment sequence R-T; Treatment sequence T-R

Eligibility Criteria

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

You may qualify if:

• Gender: Healthy male subjects.
• Age: 18 to 45 years (inclusive).
• Body Weight: Body mass index (BMI = weight (kg)/height2 (m2)) between 19.0 and 26.0 kg/m2 (inclusive), with body weight ≥ 50.0 kg.
• Taste Perception Ability: Successfully passed the taste perception ability test.
• Informed Consent: Fully understands the study's purpose, nature, requirements, methodology, and potential adverse reactions; voluntarily agrees to participate in the clinical trial and signs the informed consent form prior to any study procedures.
• Contraception: Subject (and their partner) has no plans to conceive or donate sperm from the time of first dosing until 3 months after the last dose and agrees to use effective contraception during this period.

You may not qualify if:

• Clinically significant abnormalities, as determined by the investigator, including history of neurological, respiratory, cardiovascular, gastrointestinal, urinary, hematological and lymphatic, endocrine, musculoskeletal, or other disorders that could affect study results, or history of gastrointestinal disease within 3 months prior to screening.
• Inability to accurately express true taste perception.
• Dysfunction in taste or olfactory senses.
• Known hypersensitivity or allergy to the investigational product or any of its components (e.g., copovidone, crospovidone, lactose, microcrystalline cellulose, mannitol, maltitol, hydroxypropyl methylcellulose, colloidal silicon dioxide, sodium stearyl fumarate, sucralose, strawberry flavoring), or history of allergic diseases or a predisposition to allergies.
• Clinically significant abnormalities in vital signs, physical examination, clinical laboratory tests, 12-lead ECG, or chest X-ray (posteroanterior view), or QTcF \>450 ms, as assessed by the investigator.
• Positive test results for hepatitis B surface antigen (HBsAg), HCV antibodies, Treponema pallidum antibodies, or HIV antibodies.
• Smoking ≥10 cigarettes per day within 3 months prior to the first dose.
• Surgical procedure within 3 months before the first dose or planned surgery during the study period.
• Blood donation or significant blood loss ≥400 mL within 3 months before the first dose, or plans to donate blood within 3 months after the study.
• Participation in another clinical drug trial within 3 months before the first dose.
• Difficulty swallowing.
• Intolerance to skin puncture, fear of blood or needles, or poor venous access for blood sampling.
• Special dietary requirements or inability to adhere to the provided diet and study dietary restrictions.
• Positive urine drug screen, history of substance abuse within the past 5 years, or use of illicit drugs within 3 months before the first dose.
• Alcohol consumption exceeding 21 units per week (1 unit = 360 mL beer, 45 mL spirits with 40% alcohol, or 150 mL wine) within 6 months prior to screening, or a positive breath alcohol test.

Sponsors & Collaborators

• Jiangxi Qingfeng Pharmaceutical Co. Ltd.: lead

Study Sites (1)

Women and Children's hospital of Ningbo University

Ningbo, China

Location

MeSH Terms

Interventions

Suspensions

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

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: October 30, 2024
• First Posted: November 7, 2024
• Study Start: September 27, 2024
• Primary Completion: February 16, 2025
• Study Completion: February 16, 2025
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)