Study of the Safety, Tolerability, Pharmacokinetics of VV913 Capsules in Chinese Healthy Participants
A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics of a Single Oral Dose of VV913 Capsules in Chinese Healthy Participants
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Contact
Study Contact
- Name: Huaqing Duan
- Phone Number: 18061926005
- Email: huaqing.duan@vigonvita.cn
Study Locations
-
-
Anhui
-
Hefei, Anhui, China, 230031
- Recruiting
- The First Affiliated Hospital of Anhui Medical University
-
Contact:
- Huan Zhou
- Phone Number: 13665527160
- Email: zhouhuanbest@vip.163.com
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 18 to 45 years old, males ;
- Males weight no less than 50 kg, with body mass index of 19 to 26 kg/m^2;
- Vital signs examination, physical examination, laboratory examination ,electrocardiogram examination chest CT are normal or considered abnormal without clinical significance by the investigator;
- Participants who are willing to take proper contraceptive methods during the study and within 3 months after the the last administration;
- Participants who are able to understand and follow the study protocol and instructions; participants who have voluntarily decided to participate in this study, and sign the informed consent form.
Exclusion Criteria:
- Participants with hypersensitivity to preparation or any of the excipients;
- Participants with allergic constitution (such as asthma, urticaria, eczematous dermatitis and other allergic diseases), or have a history of drug or food allergy;
- Participants with central nervous system, cardiovascular system, gastrointestinal, respiratory system, urinary, hematologic, or metabolic disorders that require medical intervention or other diseases (such as psychiatric history) that are not suitable for clinical trials; Participants with a history of gastrointestinal conditions that may impair drug absorption (e.g., gastrectomy or small intestine resection, atrophic gastritis, gastrointestinal ulcers or perforations/fistulas, gastrointestinal bleeding, or obstruction);
- Participants with a history of surgery within 3 months before screening, or have not recovered from surgery, or have an expected surgical plan during the trial;
- Participants with a blood donation or blood loss ≥ 400 mL within 3 months before screening, or a history of blood product use within 3 months before screening;
- Participating in any clinical trial and taking clinical trial drugs within 90 days before screening;
- Participants who have taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health products within 14 days before screening;
- Participants who have received vaccination within 14 days before screening, or planned to receive any vaccine during the trial or within 1 week after the end of the study;
- Participants with a history of drug abuse within 1 year before screening or positive urine drug screening within 1 year before screening results (morphine, tetrahydrocannabinol, methamphetamine, dimethylene diphenazine , ketamine, and cocaine);
- Participants who drink more than 14 standard units or at least twice a day per week within one year before screening (one standard unit equals 200 mL of beer with 5% alcohol or 25 mL of spirits with 40% alcohol content or 85 mL of wine with 12% alcohol content);
- Participants who smoke more than 5 cigarettes a day within one year before screening;
- Participants who can't quit smoking or drinking during the trial period;
- Participants who are positive for hepatitis B virus surface antigen, hepatitis C virus antibody, treponema pallidum antibody or human immunodeficiency virus antibody (Anti-HIV);
- Having special requirements for food, unable to observe a unified diet or having dysphagia;
- Participants who cannot avoid consuming drinks containing xanthine (such as coffee and tea) or foods (such as chocolate and animal liver), or fruits or juices (such as grapefruit, pomelo, mango, and dragon fruit) that may affect drug metabolism,from 48 hours before administration until the end of the study;
- Participants who cannot tolerate blood collection with intravenous indwelling needles or blood fainting;
- Participants with difficulty in swallowing capsules;
- Participants whose female partners plan to conceive within 3 months;
- The investigator believes that there are other unsuitable factors to participate this trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo
|
6 participants will receive VV913 1mg orally; 2 participants will receive placebo orally.
6 participants will receive VV913 2mg orally; 2 participants will receive placebo orally.
6 participants will receive VV913 4mg orally; 2 participants will receive placebo orally.
6 participants will receive VV913 8mg orally; 2 participants will receive placebo orally.
6 participants will receive VV913 15mg orally; 2 participants will receive placebo orally.
6 participants will receive VV913 25mg orally; 2 participants will receive placebo orally.
6 participants will receive VV913 40mg orally; 2 participants will receive placebo orally.
|
|
Experimental: VV913
|
6 participants will receive VV913 1mg orally; 2 participants will receive placebo orally.
6 participants will receive VV913 2mg orally; 2 participants will receive placebo orally.
6 participants will receive VV913 4mg orally; 2 participants will receive placebo orally.
6 participants will receive VV913 8mg orally; 2 participants will receive placebo orally.
6 participants will receive VV913 15mg orally; 2 participants will receive placebo orally.
6 participants will receive VV913 25mg orally; 2 participants will receive placebo orally.
6 participants will receive VV913 40mg orally; 2 participants will receive placebo orally.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
AE & SAE
Time Frame: from day1 to day7 after administration
|
Adverse event & serious adverse events
|
from day1 to day7 after administration
|
|
Cmax
Time Frame: 72 hours after administration
|
maximum observed plasma concentration
|
72 hours after administration
|
|
Tmax
Time Frame: 72 hours after administration
|
time at which Cmax occurs
|
72 hours after administration
|
|
t1/2
Time Frame: 72 hours after administration
|
half life of elimination
|
72 hours after administration
|
|
AUC0-t
Time Frame: 72 hours after administration
|
area under the plasma concentration time curve from time zero to the last measurable concentration
|
72 hours after administration
|
|
AUC0-∞
Time Frame: 72 hours after administration
|
area under the plasma concentration-time curve from time zero to infinity
|
72 hours after administration
|
|
Kel
Time Frame: 72 hours after administration
|
elimination rate constant
|
72 hours after administration
|
|
Vd/F
Time Frame: 72 hours after administration
|
apparent volume of distribution during the terminal phase
|
72 hours after administration
|
|
MRT
Time Frame: 72 hours after administration
|
mean residence time
|
72 hours after administration
|
|
CL/F
Time Frame: 72 hours after administration
|
apparent clearance
|
72 hours after administration
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Huan Zhou, The First Affiliated Hospital of Anhui Medical University
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- VV913-01
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
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