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OpenTrials
Completed

NCT Number: NCT05118516

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

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.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

8307 Gault Lane

San Antonio, Texas, 78209, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

ASC43F

Drug

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

Primary outcomes

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

    Time frame: Baseline to day 7

Secondary outcomes

  1. To evaluate the pharmacokinetics as assessed by Cmax (Max Concentration) of ASC43F tablet following a single fixed oral dose in healthy subjects

    Time frame: Baseline to day 4

  2. To evaluate the pharmacokinetics as assessed by Area Under the Curve (AUC) of ASC43F tablet following a single fixed oral dose in healthy subjects

    Time frame: Baseline to day 4

  3. To evaluate the pharmacokinetics as assessed by Tmax (Time to Max Concentration) of ASC43F tablet following a single fixed oral dose in healthy subjects

    Time frame: Baseline to day 4

Sponsors and collaborators

Lead sponsor

Gannex Pharma Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 12, 2021
Registry last updated
Sep 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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