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

March 8, 2018 updated by: Sunshine Lake Pharma Co., Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100034
        • Peking University First Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 30 mg single dose
Healthy subjects, receiving a single dose of 30 mg yimitasvir(N=6) or placebo(N=2)
Drug: yimitasvir
Capsule administered orally once daily
Other Names:
  • DAG181
Drug: placebo
Matching Placebo Capsule
Other Names:
  • DAG181 placebo
EXPERIMENTAL: 100 mg single dose
Healthy subjects, receiving a single dose of 100 mg yimitasvir (N=6) or placebo(N=2)
Drug: yimitasvir
Capsule administered orally once daily
Other Names:
  • DAG181
Drug: placebo
Matching Placebo Capsule
Other Names:
  • DAG181 placebo
EXPERIMENTAL: 200 mg single dose
Healthy subjects, receiving a single dose of 200 mg yimitasvir (N=6) or placebo(N=2)
Drug: yimitasvir
Capsule administered orally once daily
Other Names:
  • DAG181
Drug: placebo
Matching Placebo Capsule
Other Names:
  • DAG181 placebo
EXPERIMENTAL: 400 mg single dose
Healthy subjects, receiving a single dose of 400 mg yimitasvir (N=6) or placebo(N=2)
Drug: yimitasvir
Capsule administered orally once daily
Other Names:
  • DAG181
Drug: placebo
Matching Placebo Capsule
Other Names:
  • DAG181 placebo
EXPERIMENTAL: 600 mg single dose
Healthy subjects, receiving a single dose of 600 mg yimitasvir (N=6) or placebo(N=2)
Drug: yimitasvir
Capsule administered orally once daily
Other Names:
  • DAG181
Drug: placebo
Matching Placebo Capsule
Other Names:
  • DAG181 placebo
EXPERIMENTAL: 800 mg single dose
Healthy subjects, receiving a single dose of 800 mg yimitasvir (N=6) or placebo(N=2)
Drug: yimitasvir
Capsule administered orally once daily
Other Names:
  • DAG181
Drug: placebo
Matching Placebo Capsule
Other Names:
  • DAG181 placebo
EXPERIMENTAL: 1000 mg single dose
Healthy subjects, receiving a single dose of 1000 mg yimitasvir (N=6) or placebo(N=2)
Drug: yimitasvir
Capsule administered orally once daily
Other Names:
  • DAG181
Drug: placebo
Matching Placebo Capsule
Other Names:
  • DAG181 placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: Baseline to day 10
To assess the safety and tolerability after a single dose of DAG181
Baseline to day 10
Cmax
Time Frame: 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
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 Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunshine Lake Pharma Co., Ltd.

Investigators

  • Principal Investigator: Yimin Cui, Doctor, Peking University First Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 3, 2014

Primary Completion (ACTUAL)

January 30, 2015

Study Completion (ACTUAL)

January 22, 2016

Study Registration Dates

First Submitted

February 9, 2018

First Submitted That Met QC Criteria

March 8, 2018

First Posted (ACTUAL)

March 12, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 12, 2018

Last Update Submitted That Met QC Criteria

March 8, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCD-DDAG181PA-13-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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