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Tests treatment safety and results for Influenza
Official title First-in-Human Study of VNT-101: Safety, Tolerability, and Pharmacokinetics
ClinicalTrials.gov ID: NCT07169318
What this study is testing
What is VNT-101?
VNT-101 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for influenza.
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
- A randomized, double-blind, placebo-controlled Phase 1 study conducted at a single center with approximately 78 healthy adults aged 18-59 years. Part 1 Single Ascending Dose (SAD) will enroll 48 participants into six cohorts (S1-S6) to receive single oral doses of VNT-101 (100-1500 mg) or placebo under fasting or fed (S5 only) conditions.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
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 59. Healthy volunteers may be eligible.
You may be able to join if
- Provides written informed consent prior to the initiation of any trial procedures.
- Able to understand and agrees to comply with all planned trial procedures and be available for all study visits.
- Healthy, adult, male or female (of non-childbearing potential only\ ), 18-59 years of age, inclusive, at the screening visit. \ Female participants...
- Continuous non-smoker who has not used nicotine-, tobacco-, cannabis-, or cannabidiol-containing products\ \ prior to the first dosing based on...
- Body mass index (BMI)\>/=18.0 and \</= 30.0 kg/m\^2 at the screening visit.
You likely can't join if
- History or presence of clinically significant medical or psychiatric condition or disease, making the participant unsuitable for enrollment in the...
- History of severe allergic or anaphylactic reactions to any prescription or non-prescription drug or vaccine.
- Participants who took any prescription medications within 14 days of first dosing or within 5 half-lives of the drug, whichever is longer.
- Participants who took any over the counter (OTC) medication/vitamins/herbal supplements\ in the last 7 days prior to first dosing. \ Exception for...
- History or diagnosis of a cardiovascular disease condition, including myocardial infarction, angina, congenital heart disease, cardiomyopathy...
- Increased risk for peptic ulcer\ \ \ \ \ \ Defined as: participants with a history of gastric or duodenal ulcer, chronic non-steroidal...
See the full eligibility criteria
Who can join
- Provides written informed consent prior to the initiation of any trial procedures.
- Able to understand and agrees to comply with all planned trial procedures and be available for all study visits.
- Healthy, adult, male or female (of non-childbearing potential only\ ), 18-59 years of age, inclusive, at the screening visit. \ Female participants of non-childbearing potential must be either surgically sterile (i.e...
- Continuous non-smoker who has not used nicotine-, tobacco-, cannabis-, or cannabidiol-containing products\ \ prior to the first dosing based on participant self-reporting. \ \ The period before first dose is at least 3...
- Body mass index (BMI)\>/=18.0 and \</= 30.0 kg/m\^2 at the screening visit.
- Medically healthy\ \ \ with no clinically significant medical history, physical examination, laboratory profiles, vital signs, and ECGs, as deemed by the Principal Investigator (PI) or designee, \ \ \ Including the...
- Supine diastolic blood pressure is \>/= 40 mmHg and \</= 90 mmHg at the screening visit.
- Supine systolic blood pressure is \>/= 90 mmHg and \</= 140 mmHg at the screening visit.
- Supine heart rate is \>/= 60 bpm and\</= 100 bpm at the screening visit.
- QTcF interval is \</= 460 msec (males) and \</=470 msec (females) and has ECG findings considered normal or not clinically significant by the PI or designee at the screening visit.
- Estimated creatinine clearance \>/= 80 mL/min based on the Cockroft-Gault equation and creatinine \<1.50 mg/dL at the screening visit.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is not greater than 1.1 times the upper limit of normal (ULN), as specified by the testing laboratory.
- Other clinical laboratory values within normal range as specified by the testing laboratory, unless deemed not clinically significant by the PI or designee.
- Must agree to refrain from using tanning salons, saunas, sunbathing, or prolonged sun exposure during participation in the study through the follow-up visit.
- Male participants must agree not to donate sperm during the study and for 90 days following the last administration of Study Product.
- Male participants must agree to use a medically accepted contraceptive regimen\ \ \ \ during participation and for 30 days after last administration of the study product or be vasectomized.
- Acceptable methods of contraception include abstinence from intercourse with a female of childbearing potential or use of male condoms with spermicide or surgical sterilization (vasectomy) of participant at least 26...
What rules you out
- History or presence of clinically significant medical or psychiatric condition or disease, making the participant unsuitable for enrollment in the opinion of the PI or designee.
- History of severe allergic or anaphylactic reactions to any prescription or non-prescription drug or vaccine.
- Participants who took any prescription medications within 14 days of first dosing or within 5 half-lives of the drug, whichever is longer.
- Participants who took any over the counter (OTC) medication/vitamins/herbal supplements\ in the last 7 days prior to first dosing. \ Exception for occasional use of OTC acetaminophen (paracetamol) 325 to 500 mg every 4...
- History or diagnosis of a cardiovascular disease condition, including myocardial infarction, angina, congenital heart disease, cardiomyopathy, hypertension, or hypercholesteremia\ \ . \ \ Defined as: clinically...
- Increased risk for peptic ulcer\ \ \ \ \ \ Defined as: participants with a history of gastric or duodenal ulcer, chronic non-steroidal anti-inflammatory drug use in the past 3 months, current smokers, alcohol...
- Female participant with a positive pregnancy test at the screening visit or at baseline or who is lactating.
- Positive urine drug toxicology test (or cotinine or alcohol results) at the screening visit or check-in.
- Has been on a diet incompatible with the on-study diet\ \ \ \ , in the opinion of the PI or designee, within the 30 days prior to the first dosing, \ \ \ \ including consumption of grapefruit/Seville orange within 14...
- For Cohorts S2, S3, and S5 only, is known to be intolerant of a high fat/high calorie diet.
- Participants who are unlikely to comply with the study protocol OR those who would not be suitable candidates for participation in the opinion of the investigator.
- Participants who donated blood or plasma recently\ \ \ \ \ \ \ \ \ \ Recently defined as within 30 days prior to Day -1, or loss of whole blood of more than 500 mL within 30 days prior to Day-1, or receipt of a blood...
- Participated in a clinical study involving administration of an investigational drug in the past 30 days (90 days for injectable biological agent) before screening.
The study team makes the final eligibility decision.
Where it's taking place
- Overland Park, Kansas, United States
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 all sexes, 18 years to 59 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Overland Park, Kansas, United States. 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.