Clinical trial NCT03462173: The Safety, Tolerability and Pharmacokinetic Study of Yimitasvir in Healthy Adults Subjects
Official title: A Phase I, Randomized，Double-blind, Placebo-controlled, Single Ascending Dose, Single-center Study to Assess the Safety, Tolerability and Pharmacokinetic of Yimitasvir in Healthy Adults 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: 2018-03-12
Enrollment: 32
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 Safety, Tolerability and Pharmacokinetic Study of Chronic Hepatitis C Treatment Drug Yimitasvir in Healthy Adults Subjects.

Detailed description: This was a Randomized，Double-blind, Placebo-controlled, Single Ascending Dose, Single-center Study to Assess the Safety, Tolerability and Pharmacokinetic of Yimitasvir in Healthy Adults Subjects

A total of 56 healthy subjects were divided into 7 groups, with each group consisting of 8 subjects. Six of the subjects received the investigational drug, and two received placebo. All of the subjects received a single dose.

Eligibility criteria: Inclusion Criteria:

* Male or female, overall healthy subjects;
* Between 18 and 45 years of age, inclusive, similar ages;
* Body weight should be≥50 kg; Body Mass Index (BMI) is between 19 and 25 kg/m2, inclusive, similar body weights;
* Able to comprehend and sign the ICF voluntarily prior to initiate the study;
* Able to communicate well with the investigator and complete the study according to the protocol.

Exclusion Criteria:

* Pregnant or nursing female, or plan for pregnancy within 6 months;
* Female with positive urine pregnancy test results;
* Positive test results for HBsAg, anti-HCV Ab, anti-HIV Ab or syphilis;
* Have taken any drug inhibiting gastric acid secretion within 1 month prior to study drug administration, such as: H2 receptor antagonists (eg: Cimetidine, Ranitidine, Famotidine, Nizatidine and Roxatidine); Proton pump inhibitors (eg: Omeprazole, Lansoprazole, Rabeprazole, Pantoprazole and Esomeprazole); cholinoceptor blocking drugs (eg: Atropine and Pirenzepine);
* History of immune system disease (such as thymus disease);
* Have undergone major surgery within 6 months before enrollment;
* History of tumor;
* Drink frequently within 6 months prior to study drug administration, namely alcohol consumption are more than 20 grams per day;
* Smokers, who smoke more than 1 cigarettes/day within 3 months before the study;
* Participated in any clinical trial within 3 months prior to the study;
* Cannot be tolerant to oral drugs.

Primary outcomes:
measure: Adverse events
timeFrame: Baseline to day 10
measure: Cmax
timeFrame: Prior to dosing (0 h) and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 h after dosing
measure: Tmax
timeFrame: Prior to dosing (0 h) and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 h after dosing
measure: AUC
timeFrame: Prior to dosing (0 h) and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 h after dosing
measure: T1/2
timeFrame: Prior to dosing (0 h) and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 h after dosing
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: Yimin Cui, Doctor
role: PRINCIPAL_INVESTIGATOR
References: