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

Sponsor

Gannex Pharma Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT05118516

Collaborator

(none)

Enrollment

Location

Arm

1.2

Actual Duration (Months)

6.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteer	Drug: ASC43F	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

8 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

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

Actual Study Start Date :

Nov 1, 2021

Actual Primary Completion Date :

Dec 7, 2021

Actual Study Completion Date :

Dec 7, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental ASC43F for all subjects under the fasted state.	Drug: ASC43F One dose of oral ASC43F FDC tablet containing ASC41 5mg and ASC42 15mg.

Arm

Intervention/Treatment

Experimental: Experimental

ASC43F for all subjects under the fasted state.

Drug: ASC43F

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

Outcome Measures

Primary Outcome Measures

Safety and tolerability of ASC43F evaluated by incidence of treatment emergent adverse events (TEAEs). [Baseline to day 7]

Secondary Outcome Measures

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]
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]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.).