- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05088174
A Trial of Hetrombopag in Healthy Subjects
October 12, 2021 updated by: Jiangsu HengRui Medicine Co., Ltd.
A Single-Center, Single-Arm, Open-Label, Self-Controlled, Drug-Drug Interaction Study of Hetrombopag Olamine and Ciclosporin in Healthy Subjects
This is a single-center, single-arm, open-label, self-controlled, phase I clinical study.
A total of 26 male or female healthy subjects are intended to be enrolled to evaluate the PK drug-drug interaction between ciclosporin and hetrombopag.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sichuan
-
Chengdu, Sichuan, China, 610041
- West China Second University Hospital Ethics Committee
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Voluntarily sign the informed consent form prior to any study-related activities, understand the procedures and methods of the study, and agree to complete this study in strict accordance with the clinical study protocol;
- Male or female subjects aged 18-55 years (inclusive);
- Body mass index (BMI) between 18 and 26 kg/m2 (inclusive);
- Normal or abnormal but not clinically significant physical examination and laboratory test results; normal or abnormal but not clinically significant ECG;
- Have no plan for pregnancy and agree to take effective contraceptive measures from signing of informed consent form until 6 months after the last dose;
- Able to maintain a consistency of good communication with the investigators, and understand and comply with all the requirements of this study
Exclusion Criteria:
- Any previous or current serious clinical conditions of the circulatory system, endocrine system, nervous system, digestive system, respiratory system, and hematological, immunological, psychiatric and metabolic abnormalities, or any disease that may interfere with the results of this study;
- History of deep venous thrombosis or other thrombotic disorders;
- QTc > 450 ms in males or QTc > 460 ms in females through 12-lead ECG examination with clinical significance per the investigator's judgment at screening;
- Positive for hepatitis B surface antigen, hepatitis C antibody, syphilis antibody (trust), or HIV antibody;
- Positive pregnancy test result;
- Allergic constitution, or allergy to any component of hetrombopag olamine tablets and ciclosporin capsules;
- Have received surgery within 4 weeks before the first study administration, or plan to undergo surgery during the course of the study;
- Have taken any drug that alters liver enzyme activity within 28 days before the first study administration or during the study;
- Have taken any prescription drug, over-the-counter drug, herbal medicine, or health supplements within 14 days before the first study administration, or within 5 half-lives of the drug at screening; plan to take non-study drugs or health supplements during the study;
- Consumption of grapefruit or grapefruit-containing products, foods or beverages containing caffeine, xanthine, or alcohol within 48 h before the first study administration; strenuous exercise, or other factors that affect drug absorption, distribution, metabolism, and excretion;
- Have participated in any drug clinical trial and have been treated with any investigational drug or medical device within 3 months before the first study administration (per the date of signing the informed consent form);
- Have blood donation (or blood loss) of ≥ 400 mL or have received blood transfusion within 3 months before screening;
- Unable or unwilling to comply with the lifestyle requirements in the protocol;
- Addicted to smoking (≥ 5 cigarettes per day within 1 month before screening);
- Average daily alcohol consumption of > 15 g for females (e.g., 145 mL of wine, 497 mL of beer, or 43 mL of low-alcohol liquor) and > 25 g for males (e.g., 290 mL of wine, 994 mL of beer, or 86 mL of low-alcohol liquor) within 1 month before screening;
- History of drug abuse, history of drug dependence, or drug abuse screening positive (drugs include morphine, methamphetamine, ketamine, ecstasy (dimethylene dioxyamphetamine), and cannabis (tetrahydrocannabinol)) (consultation and examination), or history of drug abuse within the past five years or have used narcotics within 3 months before the study;
- Potentially unable to complete the study for other reasons or judged by the investigator as not suitable for the study.
- Intolerant to venipuncture, or history of hemophobia or fear of needles;
- Have special dietary requirements and unable to accept a standardized diet;
- Acute disease from screening to first study administration.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: D1:hetrombopag single dose,D11-D15:cyclosporine,D16 combination use of hetrombopag and cyclosporine
|
Drug: Hetrombopag Olamine Tablet Ciclosporin Soft Capsule |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Peak hetrombopag plasma concentration (Cmax)
Time Frame: 0-120 hours post dose
|
0-120 hours post dose
|
Area Under the plasma hetrombopag concentration vs time curve (AUC0-120)
Time Frame: 0-120 hours post dose
|
0-120 hours post dose
|
Area under the plasma hetrombopag concentration vs time curve (AUC0-inf)
Time Frame: 0-infinity
|
0-infinity
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to Reach Maximum Drug Concentration in Plasma After Single Dose (Tmax)
Time Frame: 0-120 hours post dose
|
0-120 hours post dose
|
Half-life Associated With the Terminal Slope (t½)
Time Frame: 0-120 hours post dose
|
0-120 hours post dose
|
The number of volunteers with adverse events as a measure of safety and tolerability
Time Frame: up to Day 22
|
up to Day 22
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 3, 2020
Primary Completion (Actual)
October 22, 2020
Study Completion (Actual)
October 22, 2020
Study Registration Dates
First Submitted
October 12, 2021
First Submitted That Met QC Criteria
October 12, 2021
First Posted (Actual)
October 21, 2021
Study Record Updates
Last Update Posted (Actual)
October 21, 2021
Last Update Submitted That Met QC Criteria
October 12, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Bone Marrow Diseases
- Hematologic Diseases
- Anemia
- Bone Marrow Failure Disorders
- Anemia, Aplastic
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antirheumatic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Dermatologic Agents
- Antifungal Agents
- Calcineurin Inhibitors
- Cyclosporine
- Cyclosporins
Other Study ID Numbers
- SHR8735-111
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
Clinical Trials on Sever Aplastic Anaemia
-
Jiangsu HengRui Medicine Co., Ltd.Completed
-
Jiangsu HengRui Medicine Co., Ltd.Completed
-
European Society for Blood and Marrow TransplantationCHUGAI sanofi-aventisTerminatedAplastic AnaemiaFrance, Netherlands, Germany, United Kingdom, Switzerland, Italy, Sweden, Greece, Czechia
-
King Faisal Specialist Hospital & Research CenterCompleted
-
National University Hospital, SingaporeUnknownHaematological Malignancies | Acquired Aplastic AnaemiaSingapore
-
Beth Israel Medical CenterCompletedImmune Thrombocytopenia | Myelodysplasia | Chemotherapy Induced Thrombocytopenia | Aplastic AnaemiaUnited States
-
Singapore General HospitalShanghai Yueyang Integrated Medicine Hospital; Singapore Bao Zhong Tang TCM...CompletedMyelodysplastic Syndrome (MDS) | Myelofibrosis (MF) | Thalassemia Intermedia | Aplastic Anaemia (AA)Singapore
-
Assistance Publique - Hôpitaux de ParisNot yet recruitingSevere Aplastic Anemia | Idiopathic Aplastic Anemia | Moderate Aplastic Anemia Requiring Transfusions
-
University of UtahNovartisCompletedSevere Aplastic Anemia | Moderate Aplastic Anemia | Very Severe Aplastic AnemiaUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)RecruitingRecurrent Severe Aplastic Anemia | Refractory Severe Aplastic AnemiaUnited States
Clinical Trials on Hetrombopag Olamine Tablet;Ciclosporin Soft Capsule
-
Jiangsu HengRui Medicine Co., Ltd.Completed
-
Jiangsu HengRui Medicine Co., Ltd.Completed
-
LEO PharmaCompleted
-
PfizerCompletedBiological AvailabilityUnited States
-
Simbec ResearchCompletedHealthy Volunteer StudyUnited Kingdom
-
GlaxoSmithKlineCompleted
-
SocraTec R&D GmbHSocraMetrics GmbHCompleted
-
Dr Bharti DaswaniResilient Cosmeceuticals Pvt. Ltd, PuneCompleted