The Safety, Tolerability and Pharmacokinetic Study of Yimitasvir in Healthy Adults Subjects

NCT03462173 | Completed Phase 1

• 1 other identifier: PCD-DDAG181PA-13-001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The Safety, Tolerability and Pharmacokinetic Study of Chronic Hepatitis C Treatment Drug Yimitasvir in Healthy Adults Subjects.

Conditions

Chronic Hepatitis c

Outcome Measures

Primary Outcomes (5)

• Adverse events

  To assess the safety and tolerability after a single dose of DAG181

  Baseline to day 10

• Cmax

  Maximum observed plasma concentration of DAG181

  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

• Tmax

  Time of the maximum observed plasma concentration

  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

• AUC

  Area under the plasma concentration-time curve (AUC)

  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

• T1/2

  Terminal elimination half-life

  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

Study Arms (7)

30 mg single dose

EXPERIMENTAL

Healthy subjects, receiving a single dose of 30 mg yimitasvir(N=6) or placebo(N=2)

Drug: yimitasvir; Drug: placebo

100 mg single dose

EXPERIMENTAL

Healthy subjects, receiving a single dose of 100 mg yimitasvir (N=6) or placebo(N=2)

Drug: yimitasvir; Drug: placebo

200 mg single dose

EXPERIMENTAL

Healthy subjects, receiving a single dose of 200 mg yimitasvir (N=6) or placebo(N=2)

Drug: yimitasvir; Drug: placebo

400 mg single dose

EXPERIMENTAL

Healthy subjects, receiving a single dose of 400 mg yimitasvir (N=6) or placebo(N=2)

Drug: yimitasvir; Drug: placebo

600 mg single dose

EXPERIMENTAL

Healthy subjects, receiving a single dose of 600 mg yimitasvir (N=6) or placebo(N=2)

Drug: yimitasvir; Drug: placebo

800 mg single dose

EXPERIMENTAL

Healthy subjects, receiving a single dose of 800 mg yimitasvir (N=6) or placebo(N=2)

Drug: yimitasvir; Drug: placebo

1000 mg single dose

EXPERIMENTAL

Healthy subjects, receiving a single dose of 1000 mg yimitasvir (N=6) or placebo(N=2)

Drug: yimitasvir; Drug: placebo

Interventions

yimitasvir DRUG

Capsule administered orally once daily

Also known as: DAG181

100 mg single dose; 1000 mg single dose; 200 mg single dose; 30 mg single dose; 400 mg single dose; 600 mg single dose; 800 mg single dose

placebo DRUG

Matching Placebo Capsule

Also known as: DAG181 placebo

100 mg single dose; 1000 mg single dose; 200 mg single dose; 30 mg single dose; 400 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:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

yimitasvir

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

• Yimin Cui, Doctor

  Peking University First Hospital

  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: February 9, 2018
• First Posted: March 12, 2018
• Study Start: December 3, 2014
• Primary Completion: January 30, 2015
• Study Completion: January 22, 2016
• Last Updated: March 12, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)