A Drug-drug Interaction Study of SH229 Tablets and Daclatasvir Dihydrochloride Tablets in Healthy Subjects
A Single-center, Open-label, Steady-state Drug-drug Interaction Study of SH229 Tablets and Daclatasvir Dihydrochloride Tablets in Healthy Subjects
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Jilin
-
Changchun, Jilin, China, 130000
- Phase I Clinical Trial Unit, The First Hospital of Jilin University
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Cohort A
SH229 (600 mg) once daily, Daclatasvir dihydrochloride (60 mg) once daily.
|
tablet, oral, 600 mg once daily for day 1 to day 14
tablet, oral, 600 mg once daily for day 8 to day 14
tablet, oral, 60 mg once daily for day 8 to day 14
tablet, oral, 60 mg once daily for day 1 to day 14
|
|
Experimental: Cohort B
SH229 (600 mg) once daily, Daclatasvir dihydrochloride (60 mg) once daily.
|
tablet, oral, 600 mg once daily for day 1 to day 14
tablet, oral, 600 mg once daily for day 8 to day 14
tablet, oral, 60 mg once daily for day 8 to day 14
tablet, oral, 60 mg once daily for day 1 to day 14
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of adverse events
Time Frame: Up to 1 month after last dose
|
Cohort A and Cohort B [Safety and tolerability]
|
Up to 1 month after last dose
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tmax, ss
Time Frame: Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose
|
Time of maximum observed concentration; safety and validity criteria
|
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
|
Maximum observed concentration; safety and validity criteria
|
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
|
Minimum observed concentration; safety and validity criteria
|
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
|
Elimination half-life; safety and validity criteria
|
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
|
Area under the concentration-time curve (AUC) from time 0 to 24 hours; safety and validity criteria
|
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
|
Area under the concentration-time curve (AUC) from time 0 to 72 hours; safety and validity criteria
|
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
|
Area under the concentration-time curve (AUC) from time 0 to infinity; safety and validity criteria
|
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
|
Apparent clearance; safety and validity criteria
|
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
|
Degree of fluctuation; safety and validity criteria
|
Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Yanhua Ding, MD, Phase I Clinical Trial Unit, The First Hospital of Jilin University
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- SHC005-I-04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.