Chronic Hepatitis cPhase 1NCT03811678

The Tolerability and Pharmacokinetics Study of Kangdaprevir Sodium Tablet in Healthy Adult Subjects

A Phase 1 study testing Kangdaprevir Sodium Tablet 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 Tolerability and Pharmacokinetics Study of Kangdaprevir Sodium Tablet in Healthy Adult 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?: Kangdaprevir Sodium Tablet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 120 participants
Where: 1 siteChina
Study dates: 11 Jan 2018to 29 May 2018
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

Able to comprehend and sign the ICF voluntarily prior to initiate the study;
Able to complete the study according to the protocol;
Between 18 and 45 years of age（18 and 45 are inclusive）;
Body weight of male and female subject should be ≥50 kg and ≥45 kg respectively; Body Mass Index (BMI) is between 18 and 28 kg/m2（18 and 28 are inclusive）;
Physical examination and vital signs without clinically significant abnormalities.

Who cannot join

Smokers, who smoke more than 5 cigarettes/day within 3 months before the study;
Drink frequently, namely alcohol consumption are 14 units per week (1 unit = 285 mL of beer, or 25 mL of strong wine, or 100 mL of grape wine);
Donated blood or massive blood loss within 3 months before screening (>450 mL）;
Have any disease that increases the risk of bleeding, such as acne, acute gastritis or stomach and duodenal ulcers;
Have take any drug that changes liver enzyme activity within 1 month before taking the study drug
Have taken any prescription drug, over-the-counter drug, vitamin product or herbal medicine within 14 days prior to screening;

Show all 9Show fewer

Have participated in any clinical trial or taken any study drug within 3 months before dosing;
Viral hepatitis（including CHB and CHC）and positive test result of anti-HIV Ab or syphilis.
Have taken any alcoholic products within 24 hours prior to taking the study drug

Trial locations and contacts

1 site in 1 country.

China1 site

the First Hospital of Jilin University
Changchun, Jilin, 130021

Other trials in China

About this study

Official title: A Phase I, Single-center, Randomized，Double-blind, Placebo-controlled, Single & Multiple Ascending Dose Study to Assess the Tolerability and Pharmacokinetics of Kangdaprevir Sodium Tablet in Healthy Adult Subjects

The Tolerability and Pharmacokinetics Study of Kangdaprevir Sodium Tablet in Healthy Adult Subjects.

Read the detailed description

A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Single \& Multiple Ascending Dose Study to Access the Tolerability and Pharmacokinetics of Kangdaprevir Sodium Tablet in Healthy Adult Subjects.

Conditions: Chronic Hepatitis c
Being tested: Kangdaprevir Sodium Tablet, 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.

Kangdaprevir Sodium TabletDrug
Also called HEC84048Na
Tablet，administered orally once daily
placeboDrug
Also called HEC84048Na matching placebo
Tablet，administered orally once daily

Study groups in NCT03811678
Study group	Role	What they receive
50 mg single dose	Experimental	It includes two groups, one group is a pilot study, 2 healthy subjects receive a single dose of 50 mg Kangdaprevir Sodium Tablet . Another group is a formal study, healthy subjects receive a single dose of 50 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2). Receives: Drug: Kangdaprevir Sodium Tablet; Drug: placebo
100 mg single dose	Experimental	Healthy subjects, receiving a single dose of 100 mg Kangdaprevir Sodium Tablet (N=20) or matching placebo (N=2) under fed or fasted conditions, this group is a two-sequence, two-period crossover study. Receives: Drug: Kangdaprevir Sodium Tablet; Drug: placebo
200 mg single dose	Experimental	Healthy subjects, receiving a single dose of 200 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2). Receives: Drug: Kangdaprevir Sodium Tablet; Drug: placebo
400 mg single dose	Experimental	Healthy subjects, receiving a single dose of 400 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2). Receives: Drug: Kangdaprevir Sodium Tablet; Drug: placebo
600 mg single dose	Experimental	Healthy subjects, receiving a single dose of 600 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2). Receives: Drug: Kangdaprevir Sodium Tablet; Drug: placebo
800 mg single dose	Experimental	Healthy subjects, receiving a single dose of 800 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2). Receives: Drug: Kangdaprevir Sodium Tablet; Drug: placebo
100 mg multiple dose	Experimental	Healthy subjects, receiving 100 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo(N=2) once daily (q.d.) for 5 days. Receives: Drug: Kangdaprevir Sodium Tablet; Drug: placebo
200 mg multiple dose	Experimental	Healthy subjects, receiving 200 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo(N=2) once daily (q.d.) for 5 days. Receives: Drug: Kangdaprevir Sodium Tablet; Drug: placebo
400 mg multiple dose	Experimental	Healthy subjects, receiving 400 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo(N=2) once daily (q.d.) for 5 days. Receives: Drug: Kangdaprevir Sodium Tablet; Drug: placebo

What is being measured

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

Adverse events
To assess the tolerability after a single and multiple dose of HEC84048
Measured: Baseline to day 13
Cmax
Maximum observed plasma concentration of HEC84048
Measured: predose to 72 hour after dosing
Tmax
Time of the maximum observed plasma concentration of HEC84048
Measured: predose to 72 hour after dosing
AUC
Area under the plasma concentration-time curve (AUC)
Measured: predose to 72 hour after dosing
T1/2
Terminal elimination half-life
Measured: predose to 72 hour after dosing
Vz/F
Apparent volume of distribution
Measured: predose to 72 hour after dosing
CL/F
Oral clearance
Measured: predose to 72 hour after dosing
MRT
Mean Residence Time
Measured: predose to 72 hour after dosing

Timeline

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

11 Jan 201829 May 2018

First posted22 Jan 2019
Study start11 Jan 2018
Primary completion29 May 2018
Study completion29 May 2018

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: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03811678
Sponsor's protocol ID: PCD-DHEC84048-17-01
Status last verified: Mar 2020
First submitted: 16 Jan 2019
Last updated: 19 Mar 2020
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 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Single-center, Randomized，Double-blind, Placebo-controlled, Single & Multiple Ascending Dose Study to Assess the Tolerability and Pharmacokinetics of Kangdaprevir Sodium Tablet in Healthy Adult Subjects
ClinicalTrials.gov ID: NCT03811678
Acronym / sponsor ID: PCD-DHEC84048-17-01
Conditions: Chronic Hepatitis c
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Sunshine Lake Pharma Co., Ltd.Industry (pharma, biotech, devices)
Study start: 11 Jan 2018 (actual)
Primary completion: 29 May 2018 (actual)
Study completion: 29 May 2018 (actual)
First posted: 22 Jan 2019 (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 Tolerability and Pharmacokinetics Study of Kangdaprevir Sodium Tablet in Healthy Adult Subjects.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 9

Arm	Type	Receives
50 mg single dose	Experimental	Drug: Kangdaprevir Sodium Tablet, Drug: placeboIt includes two groups, one group is a pilot study, 2 healthy subjects receive a single dose of 50 mg Kangdaprevir Sodium Tablet . Another group is a formal study, healthy subjects receive a single dose of 50 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2).
100 mg single dose	Experimental	Drug: Kangdaprevir Sodium Tablet, Drug: placeboHealthy subjects, receiving a single dose of 100 mg Kangdaprevir Sodium Tablet (N=20) or matching placebo (N=2) under fed or fasted conditions, this group is a two-sequence, two-period crossover study.
200 mg single dose	Experimental	Drug: Kangdaprevir Sodium Tablet, Drug: placeboHealthy subjects, receiving a single dose of 200 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2).
400 mg single dose	Experimental	Drug: Kangdaprevir Sodium Tablet, Drug: placeboHealthy subjects, receiving a single dose of 400 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2).
600 mg single dose	Experimental	Drug: Kangdaprevir Sodium Tablet, Drug: placeboHealthy subjects, receiving a single dose of 600 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2).
800 mg single dose	Experimental	Drug: Kangdaprevir Sodium Tablet, Drug: placeboHealthy subjects, receiving a single dose of 800 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2).
100 mg multiple dose	Experimental	Drug: Kangdaprevir Sodium Tablet, Drug: placeboHealthy subjects, receiving 100 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo(N=2) once daily (q.d.) for 5 days.
200 mg multiple dose	Experimental	Drug: Kangdaprevir Sodium Tablet, Drug: placeboHealthy subjects, receiving 200 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo(N=2) once daily (q.d.) for 5 days.
400 mg multiple dose	Experimental	Drug: Kangdaprevir Sodium Tablet, Drug: placeboHealthy subjects, receiving 400 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo(N=2) once daily (q.d.) for 5 days.

Who may qualify

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

Key inclusion criteria (5 listed)

Able to comprehend and sign the ICF voluntarily prior to initiate the study;
Able to complete the study according to the protocol;
Between 18 and 45 years of age（18 and 45 are inclusive）;
Body weight of male and female subject should be ≥50 kg and ≥45 kg respectively; Body Mass Index (BMI) is between 18 and 28 kg/m2（18 and 28 are inclusive）;
Physical examination and vital signs without clinically significant abnormalities.

Key exclusion criteria (9 listed)

Smokers, who smoke more than 5 cigarettes/day within 3 months before the study;
Drink frequently, namely alcohol consumption are 14 units per week (1 unit = 285 mL of beer, or 25 mL of strong wine, or 100 mL of grape wine);
Donated blood or massive blood loss within 3 months before screening (>450 mL）;
Have any disease that increases the risk of bleeding, such as acne, acute gastritis or stomach and duodenal ulcers;
Have take any drug that changes liver enzyme activity within 1 month before taking the 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
Kangdaprevir Sodium TabletAlso: HEC84048NaTablet，administered orally once daily	Drug	100 mg multiple dose, 100 mg single dose, 200 mg multiple dose, 200 mg single dose, 400 mg multiple dose, 400 mg single dose, 50 mg single dose, 600 mg single dose, 800 mg single dose
placeboAlso: HEC84048Na matching placeboTablet，administered orally once daily	Drug	100 mg multiple dose, 100 mg single dose, 200 mg multiple dose, 200 mg single dose, 400 mg multiple dose, 400 mg single dose, 50 mg single dose, 600 mg single dose, 800 mg single dose

Primary outcome

Adverse events
Time frame: Baseline to day 13
To assess the tolerability after a single and multiple dose of HEC84048
Cmax
Time frame: predose to 72 hour after dosing
Maximum observed plasma concentration of HEC84048
Tmax
Time frame: predose to 72 hour after dosing
Time of the maximum observed plasma concentration of HEC84048
AUC
Time frame: predose to 72 hour after dosing
Area under the plasma concentration-time curve (AUC)
T1/2
Time frame: predose to 72 hour after dosing
Terminal elimination half-life
Vz/F
Time frame: predose to 72 hour after dosing
Apparent volume of distribution
CL/F
Time frame: predose to 72 hour after dosing
Oral clearance
MRT
Time frame: predose to 72 hour after dosing
Mean Residence Time

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 19 Mar 2020.
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.

Ding Yanhua, Doctor principal investigator

The First Hospital of Jilin University

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 Kangdaprevir Sodium Tablet 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 9 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 19 Mar 2020. 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 13). The study lists 8 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 NCT03811678.

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 19 Mar 2020.