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

Chronic Hepatitis c Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03673696
• Other study ID #: HEC74647-P-01
• Status: Completed
• Phase: Phase 1
• Start date: September 4, 2018
• Est. completion date: July 5, 2019

Study information

• Verified date: September 2018
• Source: Sunshine Lake Pharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: July 5, 2019
• Est. primary completion date: July 2, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Hepatitis c
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Drug:
• HEC74647PA Capsule
Capsule administered orally once daily
• placebo
Matching Placebo Capsule

Locations

Country	Name	City	State
China	The First Hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Sunshine Lake Pharma Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events of the single ascending-dose	To assess the tolerability after a single dose of HEC74647PA capsule	Baseline to day 6~13
Primary	Adverse events of the multiple ascending-dose	To assess the tolerability after multiple doses of HEC74647PA capsule	Baseline to day 12
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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