To Evaluate Drug-drug Interactions Between HEC585 and Pirfenidone or Nintedanib in Healthy Volunteers

NCT05383131 | Completed Phase 1 FDA Drug

• 1 other identifier: HEC585-P-04 / CRC-C2032
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

An open label study to evaluate drug-drug interactions between HEC585 and Pirfenidone or Nintedanib in healthy volunteers

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (4)

• Cmax of HEC585 and Pirfenidone

  0~96 hour

• AUC of HEC585 and Pirfenidone

  0~96 hour

• Cmax of HEC585 and Nintedanib

  0~96 hour

• AUC of HEC585 and Nintedanib

  0~96 hour

Study Arms (2)

HEC585 and Pirfenidone

EXPERIMENTAL

period 1 - Pirfenidone X mg, TID; period 2 - HEC585 X mg, QD; period 3 - Pirfenidone X mg, TID + HEC585 X mg, QD.

Drug: HEC585; Drug: Pirfenidone

HEC585 and Nintedanib

EXPERIMENTAL

period 1 - Nintedanib X mg, BID; period 2 - HEC585 X mg, QD; period 3 - Nintedanib X mg, BID + HEC585 X mg, QD.

Drug: HEC585; Drug: Nintedanib

Interventions

HEC585 DRUG

Mulltiple doses of HEC585 for up to 10 days

HEC585 and Nintedanib; HEC585 and Pirfenidone

Pirfenidone DRUG

Mulltiple doses of Pirfenidone for up to 3 days

HEC585 and Pirfenidone

Nintedanib DRUG

Mulltiple doses of Nintedanib for up to 7 days

HEC585 and Nintedanib

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- Subjects who are willing and are able to provide a written informed consent to participate in the study.
• Without Plann for pregnancy or pregnant within 3 months after enrollment throughout the trial.
• Subjects aged between 18 and 45 (both inclusive) years old. Healthy volunteers has a body weight ≥50 kg (for male) or ≥ 45kg (for female in the first part of the trial) 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.

You may not qualify if:

• Subjects with a positive serology for HIV antibodies, HBsAg, HCV 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, reproductive system; and/or thyroid disease or previous thyroid surgery, malignant tumor, metabolic disorder or others medical conditions that are not suitable for clinical trial participation.
• Patients with photosensitivity and/or other skin diseases. Bleeding or thrombosis risk. Allergic. Use of any prescription or non-prescription medications within 14 days prior to initial dosing，Use of 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. Positive for urine cotinine or smoked within 1 month before administration of study drug in the first part，regular smoking of more than 10 cigarettes per day within 3 months before administration of study drug in the second part.
• Donate blood or lose blood 400 mL or more within 1 month 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 another clinical trial and have taken other study drugs within 3 months prior to initial dosing.

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead

Study Sites (1)

Shanghai Xuhui Central Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

pirfenidone; nintedanib

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Design

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

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 19, 2022
• Study Start: June 23, 2021
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: May 19, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)