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Hepatic ImpairmentPhase 1NCT04552808

To Evaluate the Pharmacokinetics and Safety of Yimitasvir Phosphate Capsules in Subjects With Moderate and Severe Liver Function Impairment and in Healthy Subjects

A Phase 1 study testing Yimitasvir Phosphate in people with Hepatic Impairment, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To evaluate the pharmacokinetics and safety of Yimitasvir phosphate capsules in subjects with moderate and severe liver function impairment and healthy subjects in a single-center, non-randomized, open, single-dose administration Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Hepatic Impairment
What is being tested?
Yimitasvir Phosphate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteChina
Study dates
19 Oct 2020to 9 Jun 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions.
  • subjects and must be 18 to 70 years of age inclusive.
  • Subjects (including partners) have no pregnancy plan within 3 months after the last dose of study drug and voluntarily take effective contraceptive measures.
  • The following inclusion criteria are only applicable to healthy subjects with normal liver function (cohorts A and C) :
  • The gender and age (±5 years) of subjects in cohort A and C were paired with subjects in cohort B and D, respectively.
  • Body mass index (BMI) : 18-30 kg/m^2 (including critical value) [BMI= weight (kg)/height^2 (m^2)] (BMI matching ±15% with liver dysfunction cohort);
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  • Physical examination and vital signs without clinically significant abnormalities.
  • The following inclusion criteria are only applicable to subjects with liver dysfunction (cohort B and D) :
  • Body mass index (BMI) between 18 and 28 kg/m^2 (including critical value) is allowed for subjects with liver insufficiency without ascites or subjects with subclinical ascites detected only by ultrasound or other imaging.Subjects with clinically significant ascites with liver dysfunction were allowed to have a BMI of 18~30 kg/m^2 (including a threshold).
  • During screening, the severity of patients with liver dysfunction was evaluated according to the Child-Pugh classification : (B/moderate: Child-Pugh score 7~9; Grade C/Severe: Child Pugh score 10~15 points).
  • The liver function status of the subjects was determined to be stable between 1 month before taking the experimental drug and the end of the study, with no significant change.

Who cannot join

  • Use of >5 cigarettes per day during the past 3 months.
  • Known history of allergy to study drugs，or allergies constitution ( multiple drug and food allergies).
  • History of alcohol abuse .
  • Donation or loss of blood over 400 mL within 3 months prior to screening. 5.12-lead ECG with clinically significant.
  • The following exclusion criteria apply only to healthy subjects with normal liver function (cohorts A and C) :
  • Hepatitis B surface antigen (HBsAg) was screened for positivity.
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  • Have taken any drug (including prescription and non-prescription drugs, herbal preparations) within 2 weeks prior to taking the experimental drug.
  • The following exclusion criteria apply only to subjects with liver function impairment (cohorts B and D) :
  • ALT>10×ULN；
  • Absolute count of neutrophils <0.75×10^9/L;
  • PLT<50×10^9/L
  • HGB<60 g/L
  • AFP >100 ng/mL; If 20 ng/mL≤AFP≤100 ng/mL, liver ultrasound examination or other imaging examinations (CT, MRI, etc.) are required to exclude subjects with suspected HCC.
  • eGFR<60 mL/min/1.73m^2.

Trial locations and contacts

1 site in 1 country.

China1 site

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

Other trials in China

About this study

Official title: To Evaluate the Pharmacokinetics and Safety of Yimitasvir Phosphate Capsules in Subjects With Moderate and Severe Liver Function Impairment and Healthy Subjects in a Single-center, Non-randomized, Open, Single-dose Administration

To evaluate the pharmacokinetics and safety of Yimitasvir phosphate capsules in subjects with moderate and severe liver function impairment and healthy subjects in a single-center, non-randomized, open, single-dose administration

Read the detailed description

A phase I, a single-center, non-randomized, open, single-dose administration study to explore the safety, pharmacokinetics of Yimitasvir phosphate capsules in subjects with moderate and severe liver function impairment and healthy subjects

This study is divided into four cohorts, cohort A and cohort C in healthy subjects, cohort B for moderate liver function impairment participants, cohort D for severe liver function impairment, participants in cohort A and cohort B, group C and group D should be matched in terms of sex, age, and body mass index (BMI). A total of 32 subjects, 8 in each cohort, both male and female, are planned to be enrolled. If a complete PK blood sample is not collected due to subjects' early withdrawal from the study, new subjects will be enrolled to meet the pharmacokinetic parameters that can be evaluated for each cohort of 8 subjects.

Being tested
Yimitasvir Phosphate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Yimitasvir PhosphateDrug

    Cohort A: On the first day, 100 mg of Yimitasvir phosphate was given in a single dose on fasted by each subjects

  • Yimitasvir PhosphateDrug

    Cohort B: were subjects with moderate liver function impairment. On the first day, 100 mg of Yimitasvir phosphate was given in a single dose on fasted by each subjects.

  • Yimitasvir PhosphateDrug

    Cohort C: Cohort C are healthy subjects, cohorts C and D, should be matched in terms of sex, age, and body mass index (BMI). On the first day, 100 mg of Yimitasvir phosphate was given in a single dose on fasted by each subjects.

  • Yimitasvir PhosphateDrug

    Cohort D: were subjects with severe liver function impairment. On the first day, 100 mg of Yimitasvir phosphate was given in a single dose on fasted by each subjects.

Study groups in NCT04552808
Study groupRoleWhat they receive
Yimitasvir Phosphate CapsulesExperimentalThe mechanism of action of Yimitasvir is the specific inhibition of HCV non-structural protein NS5A
Receives: Drug: Yimitasvir Phosphate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Events

    Incidence of adverse events

    Measured: From Days 1-7

  2. Cmax

    Maximum plasma concentration of study drugs

    Measured: From Days 1-5

  3. AUC

    Maximum plasma concentration of study drugs

    Measured: From Days 1-5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2020
  2. Study start19 Oct 2020
  3. Primary completion9 Jun 2022
  4. Study completion9 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
This study is divided into four cohorts: healthy subjects in cohort A and C, moderate liver function impairment subjects in cohort B, and severe liver function impairment subjects in cohort D. Cohorts A and B, C and D should be matched in terms of gender, age, and body mass index (BMI).
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04552808
Sponsor's protocol ID
PCD-DDAG181PA-18-004
Status last verified
Oct 2020
First submitted
11 Sep 2020
Last updated
27 Oct 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Yimitasvir Phosphate in people with Hepatic Impairment, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (time frame: From Days 1-7). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04552808.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2022.

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