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Trial record 1 of 1 for:    NCT05118516
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Safety, Tolerability, and Pharmacokinetics of ASC43F, a Fixed Dose Combination Tablet in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05118516
Recruitment Status : Completed
First Posted : November 12, 2021
Last Update Posted : December 20, 2021
Sponsor:
Information provided by (Responsible Party):
Gannex Pharma Co., Ltd.

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : November 1, 2021
Actual Primary Completion Date : December 7, 2021
Actual Study Completion Date : December 7, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Safety and tolerability of ASC43F evaluated by incidence of treatment emergent adverse events (TEAEs). [ Time Frame: Baseline to day 7 ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05118516


Locations
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United States, Texas
8307 Gault Lane
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
Gannex Pharma Co., Ltd.
More Information
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Responsible Party: Gannex Pharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT05118516    
Other Study ID Numbers: ASC43F-101
First Posted: November 12, 2021    Key Record Dates
Last Update Posted: December 20, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gannex Pharma Co., Ltd.:
ASC43F
Phase 1
Thyroid hormone receptor beta agonist
 FXR agonist
ASC41
ASC42