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

Primary Purpose

Chronic Hepatitis c

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

HEC74647PA Capsule

placebo

About this trial

This is an interventional treatment trial for Chronic Hepatitis c

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

The First Hospital of Jilin University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Arm Label

50 mg single dose

100 mg single dose

200 mg single dose

400 mg single dose

600 mg single dose

800 mg single dose

100 mg multiple doses

200 mg multiple doses

400 mg multiple doses

Arm Description

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).

Healthy subjects, receiving a single dose of 100 mg HEC74647PA capsule (N=8) or matching placebo (N=2).

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.

Healthy subjects, receiving a single dose of 400 mg HEC74647PA capsule (N=8) or matching placebo (N=2).

Healthy subjects, receiving a single dose of 600 mg HEC74647PA capsule (N=8) or matching placebo (N=2).

Healthy subjects, receiving a single dose of 800 mg HEC74647PA capsule (N=8) or matching placebo (N=2).

Healthy subjects, receiving 100 mg HEC74647PA capsule (N=10) or placebo(N=2) once daily (q.d.) for 7 days.

Healthy subjects, receiving 200 mg HEC74647PA capsule (N=10) or placebo(N=2) once daily (q.d.) for 7 days.

Healthy subjects, receiving 400 mg HEC74647PA capsule (N=10) or placebo(N=2) once daily (q.d.) for 7 days.

Outcomes

Primary Outcome Measures

Adverse events of the single ascending-dose

To assess the tolerability after a single dose of HEC74647PA capsule

Adverse events of the multiple ascending-dose

To assess the tolerability after multiple doses of HEC74647PA capsule

Tmax

Time of the maximum observed plasma concentration

AUC

Area under the plasma concentration-time curve (AUC)

Cmax

Maximum observed plasma concentration of HEC74647

T1/2

Terminal elimination half-life

Vz/F

Apparent volume of distribution

CL/F

Oral clearance

MRT

Mean Residence Time

Secondary Outcome Measures

Full Information

NCT ID

NCT03673696

First Posted

September 10, 2018

Last Updated

March 17, 2020

Sponsor

Sunshine Lake Pharma Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03673696

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Completed

Study Start Date

September 4, 2018 (Actual)

Primary Completion Date

July 2, 2019 (Actual)

Study Completion Date

July 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sunshine Lake Pharma Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Hepatitis c

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

105 (Actual)

8. Arms, Groups, and Interventions

Arm Title

50 mg single dose

Arm Type

Experimental

Arm Description

Arm Title

100 mg single dose

Arm Type

Experimental

Arm Description

Healthy subjects, receiving a single dose of 100 mg HEC74647PA capsule (N=8) or matching placebo (N=2).

Arm Title

200 mg single dose

Arm Type

Experimental

Arm Description

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.

Arm Title

400 mg single dose

Arm Type

Experimental

Arm Description

Healthy subjects, receiving a single dose of 400 mg HEC74647PA capsule (N=8) or matching placebo (N=2).

Arm Title

600 mg single dose

Arm Type

Experimental

Arm Description

Healthy subjects, receiving a single dose of 600 mg HEC74647PA capsule (N=8) or matching placebo (N=2).

Arm Title

800 mg single dose

Arm Type

Experimental

Arm Description

Healthy subjects, receiving a single dose of 800 mg HEC74647PA capsule (N=8) or matching placebo (N=2).

Arm Title

100 mg multiple doses

Arm Type

Experimental

Arm Description

Healthy subjects, receiving 100 mg HEC74647PA capsule (N=10) or placebo(N=2) once daily (q.d.) for 7 days.

Arm Title

200 mg multiple doses

Arm Type

Experimental

Arm Description

Healthy subjects, receiving 200 mg HEC74647PA capsule (N=10) or placebo(N=2) once daily (q.d.) for 7 days.

Arm Title

400 mg multiple doses

Arm Type

Experimental

Arm Description

Healthy subjects, receiving 400 mg HEC74647PA capsule (N=10) or placebo(N=2) once daily (q.d.) for 7 days.

Intervention Type

Drug

Intervention Name(s)

HEC74647PA Capsule

Intervention Description

Capsule administered orally once daily

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

Matching Placebo Capsule

Primary Outcome Measure Information:

Title

Adverse events of the single ascending-dose

Description

To assess the tolerability after a single dose of HEC74647PA capsule

Time Frame

Baseline to day 6~13

Title

Adverse events of the multiple ascending-dose

Description

To assess the tolerability after multiple doses of HEC74647PA capsule

Time Frame

Baseline to day 12

Title

Tmax

Description

Time of the maximum observed plasma concentration

Time Frame