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CompletedNCT04232514Updated Nov 5, 2020

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

A Phase 1 interventional study of HEC74647 and HEC110114 in Chronic Hepatitis C, sponsored by Sunshine Lake Pharma Co., Ltd.. Completed at 1 site in China. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-05.

Sponsored by Sunshine Lake Pharma Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
28
Allocation
Non-randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study 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

Read the detailed description

This is a 2-part study with each part is an open-label study in healthy adult subjects.

Total 28 subjects will be enrolled into the study and divided into 2 part (Part A and Part B), 14 subjects in each part. With each part, the subject will be receive study drug per the defined treatment periods of Day 1\~7 and Day 13\~19.

02

Conditions studied

  • Chronic Hepatitis C
03

In context

Hepatitis C

2,321 studies on the registry are indexed under Hepatitis C; 102 are open to participants now.

This study's enrollment of 28 is below the median of 79 across 1,633 interventional studies indexed under Hepatitis C.

Browse Hepatitis C studies →

Lead sponsor

Sunshine Lake Pharma Co., Ltd. is the lead sponsor of 82 studies on the registry; 13 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 12-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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    Part A

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

    Drug: HEC74647 · Drug: HEC110114

  • Experimental
    Part B

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

    Drug: HEC74647 · Drug: HEC110114

Interventions

  • DrugHEC74647

    Administered HEC74647 200 mg orally once daily in fed state

  • DrugHEC110114

    Administered HEC110114 800 mg orally once daily in fed state

06

What researchers measure

Primary outcomes

  1. Adverse Events

    Incidence of adverse events

    Time frame: From Days 1-26

  2. Cmax

    Maximum plasma concentration of study drugs

    Time frame: Day 7-12 and Day 19-26

  3. AUC

    Maximum plasma concentration of study drugs

    Time frame: Day 7-12 and Day 19-26

07

Study locations

1 site
  • The First Hospital of Jilin University
    Changchun, Jilin 130021, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04232514
Lead sponsor
Sunshine Lake Pharma Co., Ltd.
Responsible party
Sponsor
First posted
Jan 18, 2020
Start date
Jul 15, 2020
Primary completion
Aug 10, 2020
Completion
Aug 22, 2020
Last update
Nov 5, 2020

Study contacts

Yanhua Ding, Doctor
principal investigator · The First Hospital of Jilin University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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