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

NCT03673696 | Completed Phase 1

• 1 other identifier: HEC74647-P-01
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Hepatitis c

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (9)

50 mg single dose

EXPERIMENTAL

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: HEC74647PA Capsule; Drug: placebo

100 mg single dose

EXPERIMENTAL

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

Drug: HEC74647PA Capsule; Drug: placebo

200 mg single dose

EXPERIMENTAL

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: HEC74647PA Capsule; Drug: placebo

400 mg single dose

EXPERIMENTAL

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

Drug: HEC74647PA Capsule; Drug: placebo

600 mg single dose

EXPERIMENTAL

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

Drug: HEC74647PA Capsule; Drug: placebo

800 mg single dose

EXPERIMENTAL

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

Drug: HEC74647PA Capsule; Drug: placebo

100 mg multiple doses

EXPERIMENTAL

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

Drug: HEC74647PA Capsule; Drug: placebo

200 mg multiple doses

EXPERIMENTAL

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

Drug: HEC74647PA Capsule; Drug: placebo

400 mg multiple doses

EXPERIMENTAL

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

Drug: HEC74647PA Capsule; Drug: placebo

Interventions

HEC74647PA Capsule DRUG

Capsule administered orally once daily

100 mg multiple doses; 100 mg single dose; 200 mg multiple doses; 200 mg single dose; 400 mg multiple doses; 400 mg single dose; 50 mg single dose; 600 mg single dose; 800 mg single dose

placebo DRUG

Matching Placebo Capsule

100 mg multiple doses; 100 mg single dose; 200 mg multiple doses; 200 mg single dose; 400 mg multiple doses; 400 mg single dose; 50 mg single dose; 600 mg single dose; 800 mg single dose

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

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: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: September 17, 2018
• Study Start: September 4, 2018
• Primary Completion: July 2, 2019
• Study Completion: July 5, 2019
• Last Updated: March 19, 2020

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)