Study To Investigate The Potential DDI Between HEC585 And Pirfenidone/Nintedanib In Healthy Subjects

A Single-center, Open-label Study Designed to Assess the Drug-drug Interaction of HEC585 And Pirfenidone/Nintedanib In Healthy Subjects

A single-center, open-label study designed to assess the drug-drug interaction of HEC585 and pirfenidone in healthy male and female subjects. A single-center, open-label study designed to assess the drug-drug interaction of HEC585 and nintedanib in healthy male subjects.

Study Overview

• Status: Completed
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Drug: HEC585; Drug: Pirfenidone; Drug: Nintedanib

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Shanghai Xuhui Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Subjects who are willing and are able to provide a written informed consent to participate in the study.
• Without Plann for pregnant or sperm/egg donation plan, and voluntary effective contraceptive measures during the trial period and within 3 months after the last dose.
• Subjects aged between 18 and 45 (both inclusive) years old.
• The first part of the study included male and female subjects, and the second part of the study included only male subjects.
• Healthy volunteers has a body weight ≥50 kg (for male) or ≥ 45kg (for female) and body mass index ≥19 and ≤28 kg/m2 at screening.
• Subjects, who are healthy, as having no clinically significant abnormalities in vital signs, physical examination, clinical laboratory test results, Chest X-ray and 12-lead electrocardiogram (ECG).

Exclusion Criteria:

• Subjects with a positive serology for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, human immunodeficiency virus (HIV) antibodies and/or TP antibodies at screening.
• Subjects suffering from gastrointestinal diseases that can interfere with absorption or metabolism of drugs within 6 months before screening; and/or with history of central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, immune system (such as thymus disease), reproductive system (such as prostate, testis, epididymis, ovarian disease); and/or mental illness.
• Subjects with photosensitivity and/or other skin diseases.
• Subjects with Bleeding risk.
• Subjects with known allergic history or constitution to peanuts, soybeans, study drugs or any of their components.
• Take any prescription or non-prescription medications within 14 days prior to initial dosing, or take any medications known to inhibit or induce cytochrome P enzyme drug metabolism within 28 days prior to initial dosing.
• Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing.
• Positive results from urine drug screen test.
• History of alcoholism or drink regularly within 3 months prior to the study(defined as Alcohol consumption of > 21 units/week), or positive results from alcohol breath test.
• For the first part of the study, subjects who had positive urine cotinine test or had smoked within 1 month before administration; for the second part of the study, subjects who had smoked more than 10 cigarettes per day within 3 months before administration.
• Donate blood or lose blood 400 mL or more within 3 months prior to initial dosing.
• Subjects who plan to receive or have had organ transplants.
• Females who are lactating/breastfeeding, or positive result from pregnancy test for women of child-bearing potential.
• Subjects who participated in the other clinical trial within 3 months prior to initial dosing.
• Others conditions that are not suitable for clinical trial participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HEC585 and Pirfenidone; The DDI study of HEC585 and Pirfenidone	Drug: HEC585; DDI of HEC585 and Pirfenidone：HEC585, once daily，D5-D14 and D18-D27; DDI of HEC585 and Nintedanib：HEC585，once daily，D14-D23 and D27-D36; Drug: Pirfenidone; DDI of HEC583 and Pirfenidone： Pirfenidone：three times a day，D1-D3 and D25-D27
Experimental: HEC585 and Nintedanib; The DDI study of HEC585 and Nintedanib	Drug: HEC585; DDI of HEC585 and Pirfenidone：HEC585, once daily，D5-D14 and D18-D27; DDI of HEC585 and Nintedanib：HEC585，once daily，D14-D23 and D27-D36; Drug: Nintedanib; DDI of HEC585 andNintedanib：Nintedanib，twice a day，D1-D7 and D30-D36

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the curve from 0 to 24 hours [AUC (0~24)]	Area under the curve from 0 to 24 hours under steady-state conditions for HEC585 and Pirfenidone	Day 3 for Pirfenidone monotherapy phase; Day 14 for HEC585 monotherapy phase; Day 27 for Combination phase.
Maximum Plasma Concentration (Cmax)	Maximum Observed Plasma Concentration under steady-state conditions for Pirfenidone and HEC585	Day 3 for Pirfenidone monotherapy phase; Day 14 for HEC585 monotherapy phase; Day 27 for Combination phase.
Area under the curve from 0 to 24 hours [AUC (0~24)]	Area under the curve from 0 to 24 hours under steady-state conditions for HEC585 and Nintedanib	Day 7 for Nintedanib monotherapy phase; Day 23 for HEC585 monotherapy phase; Day 36 for Combination phase.
Observed Plasma Concentration (Cmax)	Observed Plasma Concentration under steady-state conditions for HEC585 and Nintedanib	Day 7 for Nintedanib monotherapy phase; Day 23 for HEC585 monotherapy phase; Day 36 for Combination phase.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of treatment-emergent adverse events (TEAEs）	Incidence of treatment-emergent adverse events (TEAEs）assessed by CTCAE V5.0	up to 31 days（HEC585 and Pirfenidone）
Incidence of treatment-emergent adverse events (TEAEs）	Incidence of treatment-emergent adverse events (TEAEs）assessed by CTCAE V5.0	up to 40 days（HEC585 and Nintedanib）

Collaborators and Investigators

• Sponsor: Sunshine Lake Pharma Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2021
• Primary Completion (Actual): November 30, 2021
• Study Completion (Actual): November 30, 2021

Study Registration Dates

• First Submitted: March 29, 2022
• First Submitted That Met QC Criteria: May 11, 2026
• First Posted (Actual): May 15, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; pirfenidone; nintedanib
• Other Study ID Numbers: HEC585-P-04/CRC-C2032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No