Chronic Hepatitis cPhase 1NCT03462173

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

A Phase 1 study testing yimitasvir in people with Chronic Hepatitis c, 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

The Safety, Tolerability and Pharmacokinetic Study of Chronic Hepatitis C Treatment Drug Yimitasvir in Healthy Adults Subjects. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Chronic Hepatitis c
What is being tested?: yimitasvir
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 32 participants
Where: 1 siteChina
Study dates: 3 Dec 2014to 22 Jan 2016
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 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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;

Show all 11Show fewer

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Peking University First Hospital
Beijing, Beijing Municipality, 100034

Other trials in China

About this study

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

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

Read the 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.

Conditions: Chronic Hepatitis c
Being tested: yimitasvir, placebo
Medical subject headings: Hepatitis C, Chronic

What participants receive

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

yimitasvirDrug
Also called DAG181
Capsule administered orally once daily
placeboDrug
Also called DAG181 placebo
Matching Placebo Capsule

Study groups in NCT03462173
Study group	Role	What they receive
30 mg single dose	Experimental	Healthy subjects, receiving a single dose of 30 mg yimitasvir(N=6) or placebo(N=2) Receives: 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) Receives: 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) Receives: 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) Receives: 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) Receives: 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) Receives: 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) Receives: Drug: yimitasvir; Drug: placebo

What is being measured

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

Adverse events
To assess the safety and tolerability after a single dose of DAG181
Measured: Baseline to day 10
Cmax
Maximum observed plasma concentration of DAG181
Measured: 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
Measured: 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)
Measured: 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
Measured: 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

Timeline

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

3 Dec 201422 Jan 2016

First posted12 Mar 2018
Study start3 Dec 2014
Primary completion30 Jan 2015
Study completion22 Jan 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic Hepatitis cStudies 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: Randomised
Intervention model: Sequential
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03462173
Sponsor's protocol ID: PCD-DDAG181PA-13-001
Status last verified: Mar 2018
First submitted: 9 Feb 2018
Last updated: 12 Mar 2018
Results posted: No
Data monitoring committee: 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

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic

All Chronic Hepatitis c trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03462173
Acronym / sponsor ID: PCD-DDAG181PA-13-001
Conditions: Chronic Hepatitis c
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Sunshine Lake Pharma Co., Ltd.Industry (pharma, biotech, devices)
Study start: 3 Dec 2014 (actual)
Primary completion: 30 Jan 2015 (actual)
Study completion: 22 Jan 2016 (actual)
First posted: 12 Mar 2018 (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.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 7

Arm	Type	Receives
30 mg single dose	Experimental	Drug: yimitasvir, Drug: placeboHealthy subjects, receiving a single dose of 30 mg yimitasvir(N=6) or placebo(N=2)
100 mg single dose	Experimental	Drug: yimitasvir, Drug: placeboHealthy subjects, receiving a single dose of 100 mg yimitasvir (N=6) or placebo(N=2)
200 mg single dose	Experimental	Drug: yimitasvir, Drug: placeboHealthy subjects, receiving a single dose of 200 mg yimitasvir (N=6) or placebo(N=2)
400 mg single dose	Experimental	Drug: yimitasvir, Drug: placeboHealthy subjects, receiving a single dose of 400 mg yimitasvir (N=6) or placebo(N=2)
600 mg single dose	Experimental	Drug: yimitasvir, Drug: placeboHealthy subjects, receiving a single dose of 600 mg yimitasvir (N=6) or placebo(N=2)
800 mg single dose	Experimental	Drug: yimitasvir, Drug: placeboHealthy subjects, receiving a single dose of 800 mg yimitasvir (N=6) or placebo(N=2)
1000 mg single dose	Experimental	Drug: yimitasvir, Drug: placeboHealthy subjects, receiving a single dose of 1000 mg yimitasvir (N=6) or placebo(N=2)

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (11 listed)

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);

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
yimitasvirAlso: DAG181Capsule administered orally once daily	Drug	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
placeboAlso: DAG181 placeboMatching Placebo Capsule	Drug	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

Primary outcome

Adverse events
Time frame: Baseline to day 10
To assess the safety and tolerability after a single dose of DAG181
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
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
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)
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

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 12 Mar 2018.
Individual participant dataSharing planned: No

Related trials for Chronic Hepatitis c

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic

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.

Yimin Cui, Doctor principal investigator

Peking University First 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 in people with Chronic Hepatitis c, 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 5 inclusion and 11 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 12 Mar 2018. 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: Baseline to day 10). The study lists 5 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 NCT03462173.

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 12 Mar 2018.