The Safety, Tolerability and Pharmacokinetic Study of HEC68498 in Healthy Male and Female Subjects

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title: A Phase I, Double-blind, Placebo-controlled, Single Oral Dose, Safety, Tolerability, and Pharmacokinetic Study, Incorporating an Evaluation of the Effect of Food on the Pharmacokinetics of HEC68498 in Healthy Male and Female Subjects

Status Completed

Clinical Trial Summary

A Phase I, Double-blind, Placebo-controlled, Single Oral Dose, Safety, Tolerability, and Pharmacokinetic Study, Incorporating an Evaluation of the Effect of Food on the Pharmacokinetics of HEC68498 in Healthy Male and Female Subjects

Clinical Trial Description

Single-dose, sequential-group design incorporating a food-effect evaluation. Each subject will participate in 1 treatment period, except for Group 5, where each subject will participate in 2 treatment periods. In each group, 6 subjects will receive HEC68498 and 2 subjects will receive placebo. Subjects in Group 5 will receive the same dose level of HEC68498 (or placebo) in both treatment periods. All doses will be administered either after an overnight fast of at least 8 hours or, for subjects in the food-effect evaluation, approximately 30 minutes after starting a standard high-fat breakfast. The first 2 subjects in each group will be dosed (1 subject receiving HEC68498 and 1 subject receiving placebo) 48 hours prior to the remainder of the subjects. There will be a minimum of 7 days between dose escalations. The washout period for subjects in Group 5 will be determined following review of available PK data. ;

Related Conditions & MeSH terms

• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

• NCT number: NCT03502902
• Study type: Interventional
• Source: Sunshine Lake Pharma Co., Ltd.
• Status: Completed
• Phase: Phase 1
• Start date: April 26, 2018
• Completion date: March 15, 2019