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Official title Study of Food Effects of VV913 Capsules in Chinese Healthy Volunteers
ClinicalTrials.gov ID: NCT07565792
What this study is testing
What is VV913?
VV913 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for healthy volunteers.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a single-center, randomized, open label, 3×3 crossover design to assess the high-fat meal and the standard meal effects on PK of a single oral dose of VV913 in healthy adult volunteers.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, men only. Healthy volunteers may be eligible.
You may be able to join if
- 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 ,Chest X-ray are normal or considered abnormal without clinical significance by...
- 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...
You likely can't join if
- 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...
- Participants with central nervous system, cardiovascular system, gastrointestinal, respiratory system, urinary, hematologic, or metabolic disorders...
- Participants with a history of surgery within 3 months before screening, or have not recovered from surgery, or have an expected surgical plan during...
- 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...
- Participating in any clinical trial and taking clinical trial drugs within 90 days before screening;
See the full eligibility 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 ,Chest X-ray 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.
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.