Study to Evaluate the Effect of Food on the Pharmacokinetics of ASC41 in Healthy Volunteers

Gannex Pharma

Status and phase: Completed; Phase 1

Conditions: Healthy; Hyperlipidemia; NAFLD

Treatments: Drug: ASC41 tablet

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04692025

ASC41-103

Details and patient eligibility

About

This study is to evaluate the effect of food on the pharmacokinetics of a single dose of ASC41 tablet in healthy volunteers, comparing fasting and postprandial pharmacokinetic parameters of Tmax, Cmax, AUC0-t, AUC0-∞.

Enrollment: 12 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• 19kg/m2 ≤ BMI <40kg/m2.

Key Exclusion Criteria:

• A history of thyroid disease.
• History of, or current liver disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Group 1

Experimental group

Description:

ASC41 one tablet, on Day 1 before meal；ASC41 one tablet, on Day 15 after meal.

Treatment:

Drug: ASC41 tablet

Group 2

Experimental group

Description:

ASC41 one tablet, on Day 1 after meal；ASC41 one tablet, on Day 15 before meal.

Treatment:

Drug: ASC41 tablet