The Tolerability and Pharmacokinetics Study of HEC74647PA Capsule in Healthy Adult Subjects

A Phase I, Single-center, Randomized，Double-blind, Placebo-controlled, Single & Multiple Ascending Dose Study to Assess the Tolerability and Pharmacokinetics of HEC74647PA Capsule in Healthy Adult Subjects

The Tolerability and Pharmacokinetics Study of HEC74647PA Capsule in Healthy Adult Subjects

Study Overview

• Status: Completed
• Conditions: Chronic Hepatitis c
• Intervention / Treatment: Drug: placebo; Drug: HEC74647PA Capsule

Detailed Description

A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Single & Multiple Ascending Dose Study to Access the Tolerability and Pharmacokinetics of HEC74647PA Capsule in Healthy Adult Subjects.

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Hospital of Jilin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Able to comprehend and sign the ICF voluntarily prior to initiate the study;
• Able to complete the study according to the protocol;
• Between 18 and 45 years of age, inclusive, male subject should be no fertility needs;
• Body weight of male and female subject should be ≥50 kg and ≥45 kg respectively; Body Mass Index (BMI) is between 18 and 28 kg/m2, inclusive;
• Physical examination and vital signs without clinically significant abnormalities.

Exclusion Criteria:

• Smokers, who smoke more than 5 cigarettes/day within 3 months before the study;
• Drink frequently, namely alcohol consumption are 14 units per week (1 unit = 285 mL of beer, or 25 mL of strong wine, or 100 mL of grape wine);
• Donated blood or massive blood loss within 3 months before screening (>450 mL）;
• Have any disease that increases the risk of bleeding, such as acne, acute gastritis or stomach and duodenal ulcers;
• Have taken any prescription drug, over-the-counter drug, vitamin product or herbal medicine within 1 month prior to screening;
• Have participated in any clinical trial or taken any study drug within 3 months before dosing;
• Viral hepatitis（including CHB and CHC）and positive test result of anti-HIV Ab or syphilis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 50 mg single dose; It includes two group, one group is pilot study, healthy subjects receive a single dose of 50 mg HEC74647PA capsule (N=2) . Another group is formal study, healthy subjects receive a single dose of 50 mg HEC74647PA capsule (N=8) or matching placebo (N=2).	Drug: placebo; Matching Placebo Capsule; Drug: HEC74647PA Capsule; Capsule administered orally once daily
Experimental: 100 mg single dose; Healthy subjects, receiving a single dose of 100 mg HEC74647PA capsule (N=8) or matching placebo (N=2).	Drug: placebo; Matching Placebo Capsule; Drug: HEC74647PA Capsule; Capsule administered orally once daily
Experimental: 200 mg single dose; Healthy subjects, receiving a single dose of 200 mg HEC74647PA capsule (N=16) or matching placebo (N=2) under fed or fasted conditions, this group is a two-sequence, two-period crossover study.	Drug: placebo; Matching Placebo Capsule; Drug: HEC74647PA Capsule; Capsule administered orally once daily
Experimental: 400 mg single dose; Healthy subjects, receiving a single dose of 400 mg HEC74647PA capsule (N=8) or matching placebo (N=2).	Drug: placebo; Matching Placebo Capsule; Drug: HEC74647PA Capsule; Capsule administered orally once daily
Experimental: 600 mg single dose; Healthy subjects, receiving a single dose of 600 mg HEC74647PA capsule (N=8) or matching placebo (N=2).	Drug: placebo; Matching Placebo Capsule; Drug: HEC74647PA Capsule; Capsule administered orally once daily
Experimental: 800 mg single dose; Healthy subjects, receiving a single dose of 800 mg HEC74647PA capsule (N=8) or matching placebo (N=2).	Drug: placebo; Matching Placebo Capsule; Drug: HEC74647PA Capsule; Capsule administered orally once daily
Experimental: 100 mg multiple doses; Healthy subjects, receiving 100 mg HEC74647PA capsule (N=10) or placebo(N=2) once daily (q.d.) for 7 days.	Drug: placebo; Matching Placebo Capsule; Drug: HEC74647PA Capsule; Capsule administered orally once daily
Experimental: 200 mg multiple doses; Healthy subjects, receiving 200 mg HEC74647PA capsule (N=10) or placebo(N=2) once daily (q.d.) for 7 days.	Drug: placebo; Matching Placebo Capsule; Drug: HEC74647PA Capsule; Capsule administered orally once daily
Experimental: 400 mg multiple doses; Healthy subjects, receiving 400 mg HEC74647PA capsule (N=10) or placebo(N=2) once daily (q.d.) for 7 days.	Drug: placebo; Matching Placebo Capsule; Drug: HEC74647PA Capsule; Capsule administered orally once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events of the single ascending-dose	To assess the tolerability after a single dose of HEC74647PA capsule	Baseline to day 6~13
Adverse events of the multiple ascending-dose	To assess the tolerability after multiple doses of HEC74647PA capsule	Baseline to day 12
Tmax	Time of the maximum observed plasma concentration	Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing
AUC	Area under the plasma concentration-time curve (AUC)	Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing
Cmax	Maximum observed plasma concentration of HEC74647	Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing
T1/2	Terminal elimination half-life	Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing
Vz/F	Apparent volume of distribution	Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing
CL/F	Oral clearance	Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing
MRT	Mean Residence Time	Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing

Collaborators and Investigators

• Sponsor: Sunshine Lake Pharma Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2018
• Primary Completion (Actual): July 2, 2019
• Study Completion (Actual): July 5, 2019

Study Registration Dates

• First Submitted: September 10, 2018
• First Submitted That Met QC Criteria: September 13, 2018
• First Posted (Actual): September 17, 2018

Study Record Updates

• Last Update Posted (Actual): March 19, 2020
• Last Update Submitted That Met QC Criteria: March 17, 2020
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Hepatitis C; Hepatitis C, Chronic
• Other Study ID Numbers: HEC74647-P-01

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