Safety, Tolerability, and Pharmacokinetics of ASC43F, a Fixed Dose Combination Tablet in Healthy Subjects

Healthy Volunteer Clinical Trial

Official title:

A Phase 1, Open-label, Single-dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ASC43F, a Fixed-dose Combination (FDC) Oral Tablet Containing ASC41, a THR β Agonist and ASC42, an FXR Agonist in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05118516
• Other study ID #: ASC43F-101
• Status: Completed
• Phase: Phase 1
• Start date: November 1, 2021
• Est. completion date: December 7, 2021

Study information

• Verified date: October 2021
• Source: Gannex Pharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a phase 1, open-label study in healthy adults. This study is aimed at evaluating the safety, tolerability, and pharmacokinetics of ASC43F, a fixed-dose combination (FDC) and single dose tablet containing ASC41, a THR β agonist and ASC42, an FXR agonist in healthy subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: December 7, 2021
• Est. primary completion date: December 7, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy male and female subjects between 18 to 65 years of age.

• Subjects must weigh at least 50 kg (110 pounds [lbs.]) for men, and at least 45 kg (99 lbs.) for women and body mass index (BMI) within the range 18.5-32 kilogram per meter square (kg/m2).

• Physical examination and vital signs are within normal range or slightly abnormal.

Exclusion Criteria:

• Any surgical or medical condition which in the opinion of the investigator, might significantly alter the absorption, distribution, metabolism, or excretion of drugs.

• Abnormal clinical or laboratory findings that indicate diseases including but not limited to renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic disease.

• History or current electrocardiogram (ECG) abnormalities, arrhythmias or heart valve diseases.

• History of viral hepatitis or HIV

• History of drug or food allergies that caused severe hypersensitivity reactions or anaphylaxis.).

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• ASC43F
One dose of oral ASC43F FDC tablet containing ASC41 5mg and ASC42 15mg.

Locations

Country	Name	City	State
United States	8307 Gault Lane	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Gannex Pharma Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of ASC43F evaluated by incidence of treatment emergent adverse events (TEAEs).		Baseline to day 7
Secondary	To evaluate the pharmacokinetics as assessed by Cmax (Max Concentration) of ASC43F tablet following a single fixed oral dose in healthy subjects		Baseline to day 4
Secondary	To evaluate the pharmacokinetics as assessed by Area Under the Curve (AUC) of ASC43F tablet following a single fixed oral dose in healthy subjects		Baseline to day 4
Secondary	To evaluate the pharmacokinetics as assessed by Tmax (Time to Max Concentration) of ASC43F tablet following a single fixed oral dose in healthy subjects		Baseline to day 4