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

NCT05118516 | Completed Phase 1 FDA Drug

• 1 other identifier: ASC43F-101
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Keywords

ASC43F; Phase 1; Thyroid hormone receptor beta agonist; FXR agonist; ASC41; ASC42

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of ASC43F evaluated by incidence of treatment emergent adverse events (TEAEs).

  Baseline to day 7

Secondary Outcomes (3)

• 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

Study Arms (1)

Experimental

EXPERIMENTAL

ASC43F for all subjects under the fasted state.

Drug: ASC43F

Interventions

ASC43F DRUG

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

Experimental

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Gannex Pharma Co., Ltd.: lead

Study Sites (1)

8307 Gault Lane

San Antonio, Texas, 78209, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2021
• First Posted: November 12, 2021
• Study Start: November 1, 2021
• Primary Completion: December 7, 2021
• Study Completion: December 7, 2021
• Last Updated: September 27, 2024

Record last verified: 2024-09

Locations

US (1)