Renal ImpairmentPhase 1NCT04565171

Pharmacokinetics of Yimitasvir Phosphate Capsule in Subjects With Normal Renal Function and ESRD

A Phase 1 study testing Yimitasvir Phosphate Capsule in people with Renal 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

This study is to evaluate the single-dose pharmacokinetics (PK) and safety of Yimitasvir phosphate capsule in participants with End-stage renal disease without hemodialysis using matched healthy participants as a control group. Read more about this study

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Renal Impairment
What is being tested?: Yimitasvir Phosphate Capsule
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteChina
Study dates: 15 Apr 2021to 7 May 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

male or female, age 18 to 70 years of age, inclusive;
must have a calculated body mass index (BMI) from 18 to 28 kg/m2 at study screening;
Glomerular filtration rate must be < 15 mL/min /1.73 m2 for End-stage renal disease without hemodialysis group, and ≥ 90 mL/min for Normal Renal Function group(using MDRD method);
matched for age (±5 years) ,gender and BMI(±15%) with a subject in the End-stage renal disease without hemodialysis group;

Who cannot join

allergies constitution ( multiple drug and food allergies);
Use of >5 cigarettes per day during the past 3 months;
A positive test results for HbsAg, Hepatitis C antibody, HIV-1 antibody, or Treponema pallidum antibody；
History of alcohol abuse；
Donation or loss of blood over 400 mL within 3 months prior to the first dose of study drug；
Subjects deemed unsuitable by the investigator for any other reason.

Trial locations and contacts

1 site in 1 country.

China1 site

West China Hospital of Sichuan University
Chengdu, Sichuan, 610000

Other trials in China

About this study

Official title: A Single-center, Non-randomized, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of Yimitasvir Phosphate Capsule in Subjects With Normal Renal Function and End-stage Renal Disease Without Hemodialysis

Conditions: Renal Impairment
Being tested: Yimitasvir Phosphate Capsule
Medical subject headings: Renal Insufficiency

What participants receive

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

Yimitasvir Phosphate CapsuleDrug
Also called DAG181
DAG181 100 mg (100 mg Capsule) administered orally

Study groups in NCT04565171
Study group	Role	What they receive
Participants with renal impairment	Experimental	Participants with End-stage renal disease will receive a single dose of Yimitasvir Phosphate Capsule. Receives: Drug: Yimitasvir Phosphate Capsule
Participants with normal renal function	Experimental	Participants with normal renal function will receive a single dose of Yimitasvir Phosphate Capsule. Receives: Drug: Yimitasvir Phosphate Capsule

What is being measured

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

Plasma pharmacokinetics (PK) parameters of DAG181 as measured by AUC
AUC is defined as the concentration of drug area under the curve
Measured: From Days 1-5
Plasma pharmacokinetics (PK) parameters of DAG181 as measured by Cmax
Cmax is defined as the maximum concentration of drug
Measured: From Days 1-5

Secondary outcomes (1)

Incidence of adverse events
The incidence of adverse events will be summarized
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.

15 Apr 20217 May 2022

First posted25 Sep 2020
Study start15 Apr 2021
Primary completion7 May 2022
Study completion7 May 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Renal ImpairmentStudies of the same condition, open and under way.
More trials run by Sunshine Lake Pharma Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04565171
Sponsor's protocol ID: PCD-DDAG181PA-18-001
Status last verified: Sep 2020
First submitted: 22 Sep 2020
Last updated: 27 Oct 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
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Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
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Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
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Hypothermic Kidney Machine Perfusion With Omnisol
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All Renal Impairment trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-center, Non-randomized, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of Yimitasvir Phosphate Capsule in Subjects With Normal Renal Function and End-stage Renal Disease Without Hemodialysis
ClinicalTrials.gov ID: NCT04565171
Acronym / sponsor ID: PCD-DDAG181PA-18-001
Conditions: Renal Impairment
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Sunshine Lake Pharma Co., Ltd.Industry (pharma, biotech, devices)
Study start: 15 Apr 2021 (actual)
Primary completion: 7 May 2022 (actual)
Study completion: 7 May 2022 (actual)
First posted: 25 Sep 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Participants with renal impairment	Experimental	Drug: Yimitasvir Phosphate CapsuleParticipants with End-stage renal disease will receive a single dose of Yimitasvir Phosphate Capsule.
Participants with normal renal function	Experimental	Drug: Yimitasvir Phosphate CapsuleParticipants with normal renal function will receive a single dose of Yimitasvir Phosphate Capsule.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

male or female, age 18 to 70 years of age, inclusive;
must have a calculated body mass index (BMI) from 18 to 28 kg/m2 at study screening;
Glomerular filtration rate must be < 15 mL/min /1.73 m2 for End-stage renal disease without hemodialysis group, and ≥ 90 mL/min for Normal Renal Function group(using MDRD method);
matched for age (±5 years) ,gender and BMI(±15%) with a subject in the End-stage renal disease without hemodialysis group;

Key exclusion criteria (6 listed)

allergies constitution ( multiple drug and food allergies);
Use of >5 cigarettes per day during the past 3 months;
A positive test results for HbsAg, Hepatitis C antibody, HIV-1 antibody, or Treponema pallidum antibody；
History of alcohol abuse；
Donation or loss of blood over 400 mL within 3 months prior to the first dose of study drug；

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Yimitasvir Phosphate CapsuleAlso: DAG181DAG181 100 mg (100 mg Capsule) administered orally	Drug	Participants with normal renal function, Participants with renal impairment

Primary outcome

Plasma pharmacokinetics (PK) parameters of DAG181 as measured by AUC
Time frame: From Days 1-5
AUC is defined as the concentration of drug area under the curve
Plasma pharmacokinetics (PK) parameters of DAG181 as measured by Cmax
Time frame: From Days 1-5
Cmax is defined as the maximum concentration of drug

1 secondary outcome

Incidence of adverse events
Time frame: From Days 1-5

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
Individual participant dataSharing planned: No

Related trials for Renal Impairment

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

jia Miao, Doctor principal investigator

West China Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Yimitasvir Phosphate Capsule in people with Renal 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 4 inclusion and 6 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?

Plasma pharmacokinetics (PK) parameters of DAG181 as measured by AUC (time frame: From Days 1-5). The study lists 2 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 NCT04565171.

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.