DDI Study of ASC41 in HV and the PK, Safety and Tolerability in Subjects With NAFLD.

NCT04845646 | Completed Phase 1 FDA Drug

• 1 other identifier: ASC41-105
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to evaluate the effect of itraconazole, a strong inhibitor)of cytochrome P4503A , and phenytoin a strong inducer of cytochrome P450 3A, CYP3A4, CYP1A2 and CYP2C19 on the pharmacokinetics of ASC41, a THR beta agonist tables in healthy subjects. The PK, Safety and Tolerability of ASC 41 in Subjects with NAFLD will also be evaluated. Approximately 24 subjects including 16 healthy volunteers (HVs) and 8 subjects with NAFLD will be enrolled. This study consists of 3 cohorts.

Conditions

Healthy; NAFLD

Keywords

Healthy; NAFLD; DDI (Drug-Drug Interaction); Itraconazole; Phenytoin; THR beta agonist; ASC41

Outcome Measures

Primary Outcomes (2)

• AUC of ASC41

  Evaluate the Area under the plasma concentration versus time curve.

  Up to 24 days

• Cmax of ASC41

  Evaluate the Peak Plasma Concentration.

  Up to 24 days

Secondary Outcomes (4)

• t1/2 of ASC41

  Up to 24 days

• CL/F of ASC41

  Up to 24 days

• Vd/F of ASC41

  Up to 24 days

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  Up to 24 days

Study Arms (3)

ASC41 + Itraconazole group

EXPERIMENTAL

1. ASC41 5 mg po, One 5 mg ASC41 tablet on day 1 and 11. 2. Itraconazole oral capsule 200 mg po qd (2 capsules given 1x/day or 200 mg/day) on days 6-16.

Drug: ASC41; Drug: Itraconazole

ASC41 + Phenytoin group

EXPERIMENTAL

1. ASC41 5 mg po, One 5 mg ASC41 tablet on day 1 and 19. 2. Phenytoin oral capsule 300 mg (100 mg 3 x/day) on days 6-19.

Drug: ASC41; Drug: Phenytoin

ASC41 group

EXPERIMENTAL

(1) ASC41 5 mg po. One 5 mg ASC41 tablet on day 1.

Drug: ASC41

Interventions

ASC41 DRUG

5mg/tablet

ASC41 + Itraconazole group; ASC41 + Phenytoin group; ASC41 group

Itraconazole DRUG

200mg/capsule

ASC41 + Itraconazole group

Phenytoin DRUG

300mg/capsule

ASC41 + Phenytoin group

Eligibility Criteria

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

You may qualify if:

• Part I Healthy subjects between 18 to 55 years of age
• Part II
• Subjects with NAFLD
• Subjects between 18 to 65 years of age

You may not qualify if:

• Part I
• A history of thyroid disease
• A history of, or current liver disease, or liver injuries
• Platelet count \<150,000/mcL
• INR\> 1.2
• History of, or current electrocardiogram (ECG) abnormalities, arrhythmias or heart valve diseases judged to be clinically significant by the investigator
• Part II
• A history of thyroid disease
• Current or history of cirrhosis or decompensated liver disease
• AST or ALT \> 5X ULN
• DBIL \> ULN
• Acute or chronic liver disease other than NAFLD
• A history of bariatric surgery
• HbA1c \>9.5% at screening
• Testosterone or estrogen replacement therapy

Sponsors & Collaborators

• Gannex Pharma Co., Ltd.: lead

Study Sites (1)

ICON early Phase Services LLC

San Antonio, Texas, 78209, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Itraconazole; Phenytoin

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Hydantoins; Imidazolidines; Imidazoles

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2021
• First Posted: April 15, 2021
• Study Start: March 16, 2021
• Primary Completion: June 10, 2021
• Study Completion: June 10, 2021
• Last Updated: September 27, 2024

Record last verified: 2024-09

Locations

US (1)