Drug-drug Interaction Study Between HEC74647PA Capsule and HEC110114 Tablets in Healthy Subjects

NCT04232514 | Completed Phase 1

• 1 other identifier: HEC74647-P-03
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the drug-drug-interaction (DDI), pharmacokinetics (PK) and tolerability of HEC74647 combined with HEC110114 in healthy subjects

Conditions

Chronic Hepatitis C

Outcome Measures

Primary Outcomes (3)

• Adverse Events

  Incidence of adverse events

  From Days 1-26

• Cmax

  Maximum plasma concentration of study drugs

  Day 7-12 and Day 19-26

• AUC

  Maximum plasma concentration of study drugs

  Day 7-12 and Day 19-26

Study Arms (2)

Part A

EXPERIMENTAL

Subjects will receive HEC74647 on Day 1\~7 and Day13\~19, co-administration with HEC110114 on Day13\~19.

Drug: HEC74647; Drug: HEC110114

Part B

EXPERIMENTAL

Subjects will receive HEC110114 on Day 1\~7 and Day13\~19, co-administration with HEC74647 on Day13\~19.

Drug: HEC74647; Drug: HEC110114

Interventions

HEC74647 DRUG

Administered HEC74647 200 mg orally once daily in fed state

Part A; Part B

HEC110114 DRUG

Administered HEC110114 800 mg orally once daily in fed state

Part A; Part B

Eligibility Criteria

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

You may qualify if:

• Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions.
• Be able to complete the study according to the trail protocol.
• Subjects (including partners) have no pregnancy plan within 3 months after the last dose of study drug and voluntarily take effective contraceptive measures.
• Male subjects and must be 18 to 45 years of age inclusive.
• Body weight ≥ 50 kg and body mass index（BMI）between 18 and 28 kg / m2, inclusive.
• Physical examination and vital signs without clinically significant abnormalities.

You may not qualify if:

• Use of \>5 cigarettes per day during the past 3 months.
• Known history of allergy to study drugs，or allergies constitution ( multiple drug and food allergies).
• History of alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits or 100 mL of wine).
• Donation or loss of blood over 450 mL within 3 months prior to screening.
• lead ECG with clinically significant.
• Positive for Viral hepatitis (including hepatitis B and C), HIV and syphilis.
• Subjects deemed unsuitable by the investigator for any other reason.

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yanhua Ding, Doctor

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: January 18, 2020
• Study Start: July 15, 2020
• Primary Completion: August 10, 2020
• Study Completion: August 22, 2020
• Last Updated: November 5, 2020

Record last verified: 2020-11

Locations

CN (1)