The Tolerability and Pharmacokinetics Study of Kangdaprevir Sodium Tablet in Healthy Adult Subjects

Sunshine Lake Pharma

Status and phase: Completed; Phase 1

Conditions: Chronic Hepatitis c

Treatments: Drug: placebo; Drug: Kangdaprevir Sodium Tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT03811678

PCD-DHEC84048-17-01

Details and patient eligibility

About

The Tolerability and Pharmacokinetics Study of Kangdaprevir Sodium Tablet in Healthy Adult Subjects.

Full description

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

Enrollment: 120 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts 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（18 and 45 are inclusive）;
• 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（18 and 28 are 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 take any drug that changes liver enzyme activity within 1 month before taking the study drug
• Have taken any prescription drug, over-the-counter drug, vitamin product or herbal medicine within 14 days 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.
• Have taken any alcoholic products within 24 hours prior to taking the study drug

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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120 participants in 9 patient groups

50 mg single dose

Experimental group

Description:

It includes two groups, one group is a pilot study, 2 healthy subjects receive a single dose of 50 mg Kangdaprevir Sodium Tablet . Another group is a formal study, healthy subjects receive a single dose of 50 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2).

Treatment:

Drug: Kangdaprevir Sodium Tablet

Drug: placebo

100 mg single dose

Experimental group

Description:

Healthy subjects, receiving a single dose of 100 mg Kangdaprevir Sodium Tablet (N=20) or matching placebo (N=2) under fed or fasted conditions, this group is a two-sequence, two-period crossover study.

Treatment:

Drug: Kangdaprevir Sodium Tablet

Drug: placebo

200 mg single dose

Experimental group

Description:

Healthy subjects, receiving a single dose of 200 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2).

Treatment:

Drug: Kangdaprevir Sodium Tablet

Drug: placebo

400 mg single dose

Experimental group

Description:

Healthy subjects, receiving a single dose of 400 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2).

Treatment:

Drug: Kangdaprevir Sodium Tablet

Drug: placebo

600 mg single dose

Experimental group

Description:

Healthy subjects, receiving a single dose of 600 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2).

Treatment:

Drug: Kangdaprevir Sodium Tablet

Drug: placebo

800 mg single dose

Experimental group

Description:

Healthy subjects, receiving a single dose of 800 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2).

Treatment:

Drug: Kangdaprevir Sodium Tablet

Drug: placebo

100 mg multiple dose

Experimental group

Description:

Healthy subjects, receiving 100 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo(N=2) once daily (q.d.) for 5 days.

Treatment:

Drug: Kangdaprevir Sodium Tablet

Drug: placebo

200 mg multiple dose

Experimental group

Description:

Healthy subjects, receiving 200 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo(N=2) once daily (q.d.) for 5 days.

Treatment:

Drug: Kangdaprevir Sodium Tablet

Drug: placebo

400 mg multiple dose

Experimental group

Description:

Healthy subjects, receiving 400 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo(N=2) once daily (q.d.) for 5 days.

Treatment:

Drug: Kangdaprevir Sodium Tablet

Drug: placebo