Clinical trial NCT03811678: The Tolerability and Pharmacokinetics Study of Kangdaprevir Sodium Tablet 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 Kangdaprevir Sodium Tablet in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Hepatitis c
Lead sponsor: Sunshine Lake Pharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-01-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Adverse events
timeFrame: Baseline to day 13
measure: Cmax
timeFrame: predose to 72 hour after dosing
measure: Tmax
timeFrame: predose to 72 hour after dosing
measure: AUC
timeFrame: predose to 72 hour after dosing
measure: T1/2
timeFrame: predose to 72 hour after dosing
measure: Vz/F
timeFrame: predose to 72 hour after dosing
measure: CL/F
timeFrame: predose to 72 hour after dosing
measure: MRT
timeFrame: predose to 72 hour after dosing
Secondary outcomes:
Other outcomes:
Locations:
city: Changchun
country: China
facility: the First Hospital of Jilin University
state: Jilin
Study officials:
affiliation: The First Hospital of Jilin University
name: Ding Yanhua, Doctor
role: PRINCIPAL_INVESTIGATOR
References: