Pharmacokinetic Study of RO7268489 in Healthy Volunteers Assessing Period and Food Effects

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What is this study about?

This study involves no specific disease; it is conducted in healthy volunteers to examine how the body handles a single oral dose of the investigational drug RO7268489, which is provided as a liquid solution taken by mouth. The aim of the study is to assess the drug’s pharmacokinetics—that is, how it is absorbed, distributed, broken down, and removed—and to determine whether eating a meal changes these processes.

Participants will receive one dose of the medication on two separate occasions. The first dose is taken after an overnight fast, and the second dose is taken after a standard meal. After each dose, blood samples are collected over several hours to measure the total drug exposure, described as the AUC, and the highest concentration reached in the blood, called the Cmax. Safety is monitored throughout the study by checking for any unwanted side effects, referred to as adverse events, as well as routine laboratory tests, vital signs, and a simple heart rhythm test (ECG).

1 initial visit and screening

you arrive at the clinic after you have agreed to take part in the study.

staff will check your health with a physical exam, basic laboratory tests, and a brief heart rhythm test called an ecg to make sure you are healthy enough for the study.

2 first dosing period (fasted)

you will fast, meaning no food or drink except water, for at least ten hours before the visit.

on the morning of the visit you will receive a single 1 mg dose of ro7268489 taken as an oral solution.

after taking the medicine a series of blood samples will be drawn at scheduled times to measure how the medicine moves through your body.

you will stay at the clinic for several hours while the samples are collected and you will be monitored for any side effects.

3 washout period

after the first dosing day you will have a break of several days with no further doses of the study medicine to allow your body to clear the drug.

during this time you may continue normal activities but should avoid taking other investigational medicines.

4 second dosing period (fed)

you will eat a standard meal provided by the clinic.

shortly after finishing the meal you will receive another single 1 mg dose of ro7268489 as an oral solution.

blood samples will again be taken at the same scheduled times as in the first period to compare the effect of food on the medicine.

you will remain at the clinic for observation and monitoring for side effects.

5 final assessments and study completion

after the second dosing day the staff will perform a final check of vital signs, repeat laboratory tests, and an ecg to ensure everything is normal.

you will receive information about the overall study timeline and any follow‑up that may be needed.

the study will then be considered complete for you.

Who Can Join the Study?

You must be between 18 and 54 years old, including the end ages.
You must be a man or a woman who is healthy (no known illnesses or medical problems).
Your body mass index (BMI) must be between 18 and 30 kg/m². BMI is a calculation that uses your height and weight to show if you are underweight, normal weight, or overweight.
You must agree to use the birth‑control methods that the study protocol requires (such as condoms, pills, or other approved methods) during the trial.

Who Cannot Join the Study?

You have a history of serious gastrointestinal (stomach and intestine), renal (kidney), hepatic (liver), bronchopulmonary (lung), neurological (nervous system), psychiatric (mental health such as paranoia, panic attacks, extreme fear, or anxiety), cardiovascular (heart), endocrinological (hormone), hematological (blood), allergic, metabolic, cancer, or cirrhosis conditions, or you have had a severe unpleasant reaction to cannabis products.
You have a condition that could change how your body absorbs (takes in), metabolizes (processes), or eliminates (gets rid of) medicines.
You have abnormal vital signs or heart test results (electrocardiogram or ECG) that are considered significant, such as a prolonged PQ/PR interval or QT interval, or you have heart disease like heart failure, blocked arteries, heart muscle disease, or a family history of long QT syndrome or sudden death.
Your laboratory test results (including a complete blood count, chemistry panel, or urine test) show significant problems.
You have a history of serious hypersensitivity (allergic) reactions.
You have an active or uncontrolled infection (bacterial, viral, fungal, or mycobacterial such as tuberculosis), or you have had COVID‑19 symptoms or any flu or COVID‑19 vaccination within the past 6 weeks.
You have been exposed to more than three new medications in the past year, or a test shows the presence of illegal drugs or alcohol.
You test positive for hepatitis B surface antigen, hepatitis C antibodies, or HIV antibodies.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Pcixgvkotwbyhy Rwikhrja Avvgtibgat Gxlul Bsmc	Groningen	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not recruiting	05.06.2023

Trial locations

Investigated Drugs:

RO7268489

RO7268489 is an experimental medicine being tested for the first time in people. In this study participants take a single dose as a liquid you swallow. The researchers are looking at how the drug moves into the blood after it is taken, and whether the timing of the dose or eating food changes how much of the medicine gets into the bloodstream. This helps them understand how the drug works and what conditions are needed for it to be safe and effective in the future.

Trial ID:

2023-503528-25-00

Protocol code:

BP44618

Trial Phase:

Human Pharmacology (Phase I) – Other

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Pharmacokinetic Study of RO7268489 in Healthy Volunteers Assessing Period and Food Effects

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?