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

NCT03748745 | Completed Phase 1

• 1 other identifier: SHC005-I-04
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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. This study provides evidence for the designing of following clinical trial protocols.

Conditions

Drug Interactions

Keywords

HCV; SH229

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  Cohort A and Cohort B \[Safety and tolerability\]

  Up to 1 month after last dose

Secondary Outcomes (9)

• Tmax, ss

  Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose

• Cmax, ss

  Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose

• Cmin, ss

  Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose

• t1/2, ss

  Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose

• AUC0-24, ss

  Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose

Study Arms (2)

Cohort A

EXPERIMENTAL

SH229 (600 mg) once daily, Daclatasvir dihydrochloride (60 mg) once daily.

Drug: SH229; Drug: Daclatasvir dihydrochloride

Cohort B

EXPERIMENTAL

SH229 (600 mg) once daily, Daclatasvir dihydrochloride (60 mg) once daily.

Drug: SH229; Drug: Daclatasvir dihydrochloride

Interventions

SH229 DRUG

tablet, oral, 600 mg once daily for day 1 to day 14

Cohort A

Daclatasvir dihydrochloride DRUG

tablet, oral, 60 mg once daily for day 8 to day 14

Cohort A

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Nanjing Sanhome Pharmaceutical, Co., Ltd.: lead

Study Sites (1)

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

Changchun, Jilin, 130000, China

Location

MeSH Terms

Interventions

daclatasvir

Study Officials

• Yanhua Ding, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2018
• First Posted: November 21, 2018
• Study Start: November 19, 2018
• Primary Completion: December 25, 2018
• Study Completion: December 25, 2018
• Last Updated: August 13, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)