Drug InteractionsPhase 1NCT03748745

A Drug-drug Interaction Study of SH229 Tablets and Daclatasvir Dihydrochloride Tablets in Healthy Subjects

A Phase 1 study testing SH229 and Daclatasvir dihydrochloride in people with Drug Interactions, run by Nanjing Sanhome Pharmaceutical, 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 purpose of this study is to evaluate the drug-drug interaction of SH229 tablets and Daclatasvir dihydrochloride tablets. The study also evaluates the pharmacokinetics and tolerability of co-administration of SH229 tablets and Daclatasvir dihydrochloride tablets in healthy subjects. Read more about this study

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Drug Interactions
What is being tested?: SH229 and Daclatasvir dihydrochloride
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteChina
Study dates: 19 Nov 2018to 25 Dec 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
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Sign the informed consent form before the study and fully understand the study content, process and possible adverse reactions;
Be able to complete the study as required by the protocol;
Subjects (including their partners) who are willing to voluntarily take effective contraceptive measures from screening to 6 months after the last dose. See the appendix for specific contraceptive measures;
Male subjects aged 18-45 (including 18 and 45 years old);
Male subjects who weigh no less than 50 kg and have a body mass index between 18 and 28 kg / m2 (including the threshold). Body mass index (BMI) = weight (kg) / height2 (m2);
Physical examination and vital signs normal, or the abnormal signs have no clinical significance.

Who cannot join

Smoke more than 5 cigarettes per day within three months prior to study;
Subjects who are allergic to the study drugs or prone to allergies (Multiple drug and food allergies);
Subjects with history of drug and/or alcohol abuse (14 units per week: 1 unit = 285 mL of beer, or 25 mL of hard liquor, or 100 mL of wine);
Subjects with history of blood donation or massive blood loss (> 450 mL) within three months prior to screening;
Subjects with dysphagia or have history of gastrointestinal disorders which affects study drug absorption;
Subjects with any diseases that increase the risk of bleeding, such as hemorrhoids, acute gastritis, or gastric and duodenal ulcers;

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Use of any drugs that alter liver enzyme activity within 28 days prior to screening;
Use of any prescription drugs, over-the-counter drugs, vitamin products or herbal medicines within 14 days prior to screening;
Use of special diet (including dragon fruit, mango, grapefruit, etc.), strenuous activities or other factors that may affect the absorption, distribution, metabolism and excretion of the study drug within 2 weeks prior to screening;
Concomitant use of strong inhibitors or inducers of CYP3A4, P-gp or Bcrp, such as itraconazole, ketoconazole or dronedarone;
Subjects with major changes in diet or exercise habits recently;
Use of study drugs or participation in other clinical trials within three months prior to dosing;
Subjects who have ECG abnormalities with clinical significance;
Subjects who have abnormalities with clinical significant in clinical laboratory tests or other clinical findings that indicate clinically significant diseases (including but not limited to gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric or cardiovascular diseases);
Subjects with viral hepatitis (including hepatitis B and hepatitis C), AIDS antibody and/or antibody screening positive for Treponema pallidum;
Subjects with acute disease or concomitant use of drugs from screening stage to dosing;
Use of chocolate, food or beverages containing caffeine or xanthine within 24 hours prior to dosing;
Use of products containing alcohol within 24 hours prior to dosing;
Subjects with urine drug screening test positive, or with history of drug abuse in the past 5 years;
Subjects with any other reasons that investigator considers to be unsuitable for the study.

Trial locations and contacts

1 site in 1 country.

China1 site

Phase I Clinical Trial Unit, The First Hospital of Jilin University
Changchun, Jilin, 130000

Other trials in China

About this study

Official title: A Single-center, Open-label, Steady-state Drug-drug Interaction Study of SH229 Tablets and Daclatasvir Dihydrochloride Tablets in Healthy Subjects

Read the detailed description

A total of 28 evaluable healthy subjects will be enrolled in this study. The dose of SH229 is 600 mg. The dose of Daclatasvir dihydrochloride is 60 mg.

Conditions: Drug Interactions
Being tested: SH229, Daclatasvir dihydrochloride
Keywords: HCV, SH229

What participants receive

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

SH229Drug
tablet, oral, 600 mg once daily for day 1 to day 14
SH229Drug
tablet, oral, 600 mg once daily for day 8 to day 14
Daclatasvir dihydrochlorideDrug
tablet, oral, 60 mg once daily for day 8 to day 14
Daclatasvir dihydrochlorideDrug
tablet, oral, 60 mg once daily for day 1 to day 14

Study groups in NCT03748745
Study group	Role	What they receive
Cohort A	Experimental	SH229 (600 mg) once daily, Daclatasvir dihydrochloride (60 mg) once daily. Receives: Drug: SH229; Drug: Daclatasvir dihydrochloride
Cohort B	Experimental	SH229 (600 mg) once daily, Daclatasvir dihydrochloride (60 mg) once daily. Receives: Drug: SH229; Drug: Daclatasvir dihydrochloride

What is being measured

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

Incidence of adverse events
Cohort A and Cohort B [Safety and tolerability]
Measured: Up to 1 month after last dose

Secondary outcomes (9)

Tmax, ss
Time of maximum observed concentration; safety and validity criteria
Measured: Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose
Cmax, ss
Maximum observed concentration; safety and validity criteria
Measured: Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose
Cmin, ss
Minimum observed concentration; safety and validity criteria
Measured: Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose
t1/2, ss
Elimination half-life; safety and validity criteria
Measured: Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose
AUC0-24, ss
Area under the concentration-time curve (AUC) from time 0 to 24 hours; safety and validity criteria
Measured: Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose
AUC0-72, ss
Area under the concentration-time curve (AUC) from time 0 to 72 hours; safety and validity criteria
Measured: Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose
AUC0-∞, ss
Area under the concentration-time curve (AUC) from time 0 to infinity; safety and validity criteria
Measured: Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose
CL/F ss
Apparent clearance; safety and validity criteria
Measured: Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose
DF
Degree of fluctuation; safety and validity criteria
Measured: Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose

Timeline

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

19 Nov 201825 Dec 2018

First posted21 Nov 2018
Study start19 Nov 2018
Primary completion25 Dec 2018
Study completion25 Dec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Drug InteractionsStudies of the same condition, open and under way.
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: Crossover
Masking: None (open label)
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03748745
Sponsor's protocol ID: SHC005-I-04
Status last verified: Aug 2019
First submitted: 2 Nov 2018
Last updated: 13 Aug 2019
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

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All Drug Interactions trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-center, Open-label, Steady-state Drug-drug Interaction Study of SH229 Tablets and Daclatasvir Dihydrochloride Tablets in Healthy Subjects
ClinicalTrials.gov ID: NCT03748745
Acronym / sponsor ID: SHC005-I-04
Conditions: Drug Interactions
Keywords: HCV, SH229
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Nanjing Sanhome Pharmaceutical, Co., Ltd.Industry (pharma, biotech, devices)
Study start: 19 Nov 2018 (actual)
Primary completion: 25 Dec 2018 (actual)
Study completion: 25 Dec 2018 (actual)
First posted: 21 Nov 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.

Detailed description

A total of 28 evaluable healthy subjects will be enrolled in this study. The dose of SH229 is 600 mg. The dose of Daclatasvir dihydrochloride is 60 mg.

Study design

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

Arm	Type	Receives
Cohort A	Experimental	Drug: SH229, Drug: Daclatasvir dihydrochlorideSH229 (600 mg) once daily, Daclatasvir dihydrochloride (60 mg) once daily.
Cohort B	Experimental	Drug: SH229, Drug: Daclatasvir dihydrochlorideSH229 (600 mg) once daily, Daclatasvir dihydrochloride (60 mg) once daily.

Who may qualify

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

Key inclusion criteria (6 listed)

Sign the informed consent form before the study and fully understand the study content, process and possible adverse reactions;
Be able to complete the study as required by the protocol;
Subjects (including their partners) who are willing to voluntarily take effective contraceptive measures from screening to 6 months after the last dose. See the appendix for specific contraceptive measures;
Male subjects aged 18-45 (including 18 and 45 years old);
Male subjects who weigh no less than 50 kg and have a body mass index between 18 and 28 kg / m2 (including the threshold). Body mass index (BMI) = weight (kg) / height2 (m2);

Key exclusion criteria (20 listed)

Smoke more than 5 cigarettes per day within three months prior to study;
Subjects who are allergic to the study drugs or prone to allergies (Multiple drug and food allergies);
Subjects with history of drug and/or alcohol abuse (14 units per week: 1 unit = 285 mL of beer, or 25 mL of hard liquor, or 100 mL of wine);
Subjects with history of blood donation or massive blood loss (> 450 mL) within three months prior to screening;
Subjects with dysphagia or have history of gastrointestinal disorders which affects study drug absorption;

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
SH229tablet, oral, 600 mg once daily for day 1 to day 14	Drug	Cohort A
SH229tablet, oral, 600 mg once daily for day 8 to day 14	Drug	Cohort B
Daclatasvir dihydrochloridetablet, oral, 60 mg once daily for day 8 to day 14	Drug	Cohort A
Daclatasvir dihydrochloridetablet, oral, 60 mg once daily for day 1 to day 14	Drug	Cohort B

Primary outcome

Incidence of adverse events
Time frame: Up to 1 month after last dose
Cohort A and Cohort B [Safety and tolerability]

9 secondary outcomes

Tmax, ss
Time frame: Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose
Cmax, ss
Time frame: Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose
Cmin, ss
Time frame: Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose
t1/2, ss
Time frame: Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose
AUC0-24, ss
Time frame: Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose
AUC0-72, ss
Time frame: Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose
AUC0-∞, ss
Time frame: Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose
CL/F ss
Time frame: Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose
DF
Time frame: Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose

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 13 Aug 2019.
Individual participant dataSharing planned: No

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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.

Yanhua Ding, MD principal investigator

Phase I Clinical Trial Unit, 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 SH229 and Daclatasvir dihydrochloride in people with Drug Interactions, run by Nanjing Sanhome Pharmaceutical, 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 6 inclusion and 20 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 13 Aug 2019. 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?

Incidence of adverse events (time frame: Up to 1 month after last dose). 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 NCT03748745.

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 13 Aug 2019; AzTrials last refreshed its copy on 8 Nov 2026.