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A study to evaluate the taste of sisunatovir and denatonium benzoate in healthy adults for the treatment of respiratory syncytial virus (RSV)

InvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on respiratory syncytial virus, which is a common lung infection. The research aims to evaluate how the taste and feel of different liquid versions of the drug sisunatovir are perceived by healthy adults. To help manage the taste of the medicine, denatonium benzoate, a substance used to add a bitter flavor, may be included in the preparations.

Participants will take different liquid versions of the study medicine in a single-blind format, meaning they will not know which specific version they are receiving. During the study, various liquid bases will be used to create a suspension, which is a mixture where solid particles are dispersed throughout a liquid. The experience will be assessed based on sensations such as bitterness, sweetness, sourness, saltiness, the feeling in the mouth, and any burning sensations on the tongue.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Study participation
After joining the study, different types of sisunatovir medicine will be provided to test how they taste and feel in the mouth.
The sisunatovir is given as a hard capsule containing 200 mg (milligrams) to be taken by mouth.
Step 2
Taste and sensation assessment
The taste and texture of the medicine will be evaluated using a questionnaire. this assessment covers mouth feel, bitterness, sweetness, sourness, saltiness, tongue or mouth burn, and overall liking.
Step 3
Background medication
A background medication called denatonium benzoate, provided as an oral solution (liquid to swallow) at a dose of 2 µg (micrograms), may be used.
Step 4
Safety monitoring
Monitoring is conducted to track any side effects, changes in laboratory tests, or changes in vital signs (such as blood pressure or heart rate) that occur during the treatment.

Who can join the trial?

8 criteria

Both men and women are eligible to participate.
Participants must be at least 18 years old or the legal age required to give consent in your area.
You must be considered overtly healthy, which means a doctor confirms through your medical history (your past health records), a physical examination (a general checkup), and various tests that you do not have underlying health problems.
You must have normal results from laboratory tests, which are checks of your bodily fluids like blood or urine.
Your blood pressure (the force of blood against your artery walls) and pulse rate (how fast your heart beats) must be within a healthy range.
You must undergo a 12-lead electrocardiogram (ECG), which is a test that records the electrical activity of your heart to ensure it is working correctly.
Your Body Mass Index (BMI), which is a measurement calculated from your height and weight to determine if you are in a healthy weight range, must be between 16 and 32 kg/m2.
Your total body weight must be greater than 45 kg (110 lb).

Who cannot join the trial?

14 criteria

You have a history or current signs of significant problems with your blood, kidneys, hormones, lungs, digestive system, heart, liver, mental health, or nervous system.
You have a history of HIV (a virus that affects the immune system), Hepatitis B, or Hepatitis C (viruses that affect the liver), or you have tested positive for them.
Your blood pressure (the force of your blood moving through your arteries) is too high after resting for 5 minutes. For people under 60, this is a top number of 140 or higher or a bottom number of 90 or higher; for those 60 and older, the top number must be below 150 and the bottom number below 90.
You have renal impairment, which means your kidneys are not filtering your blood as well as they should, measured by a calculation called eGFR.
An ECG (a test that records the electrical activity of your heart) shows abnormal rhythms or patterns, such as QTcF (a measurement of the time it takes for your heart muscle to recharge) or arrhythmias (irregular heartbeats).
Your blood tests show high levels of certain liver enzymes (proteins that help with chemical reactions in the liver) like ALT or AST, or high levels of bilirubin (a yellow substance made during the normal breakdown of red blood cells).
You have any mental health conditions, including suicidal ideation (thoughts about self-harm) within the last year.
You have any condition that affects your sense of taste, such as dysgeusia (a distorted sense of taste) or a respiratory infection like a cold.
You have a history of hypersensitivity (an allergic reaction) to the active ingredients or the inactive parts of the study medication.
You have taken any prescription drugs, over-the-counter medicines, or herbal supplements within a specific timeframe before the study, especially certain medicines that affect how the body processes drugs via cytochrome P450 3A.
You have taken another investigational product (a drug or vaccine being studied) within the last 30 days.
You test positive for drugs in a urine test.
You are pregnant or have a positive pregnancy test.
You use tobacco or nicotine products, confirmed by a test for cotinine (a substance found in your body after using nicotine).

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Investigated drugs

Sisunatovir
is an experimental medication being tested to see how it tastes when mixed into different liquid forms. The study aims to find the best way to make this medicine easy for people to swallow by improving its flavor.
Denatonium benzoate
is a substance added to the liquid to make it taste extremely bitter. In this study, it is used to see how adding a bitter taste affects how people perceive the flavor of the experimental medication.

Sisunatovir

What is already known about the treatment

Sisunatovir
This medication is taken by mouth in the form of a hard capsule and is currently being studied in clinical trials to evaluate its potential for treating respiratory syncytial virus (RSV). It belongs to a class of drugs known as antiviral agents that work by blocking a specific protein the virus needs to multiply inside the body. Researchers are currently investigating how to turn this substance into a liquid form that is easier for patients to swallow.
Denatonium benzoate
This substance is administered orally as a liquid solution and is commonly used in medicine as a highly bitter additive to prevent accidental swallowing or misuse of certain products. It acts by stimulating bitter taste receptors on the tongue to create an intense, unpleasant sensation. While it is well-established in medical literature for this purpose, it is being used in this study as a background substance to help test how other medications taste.

Investigated diseases

Respiratory syncytial virus infection - This is a common respiratory illness caused by a specific virus. It typically begins with symptoms similar to a common cold, such as a runny nose and coughing. As the infection progresses, it can move deeper into the lungs and affect the airways. This can lead to increased difficulty in breathing or wheezing. The virus spreads through droplets released when an infected person coughs or sneezes.