Study on the Effects of Food on Two Formulations of Nerandomilast in Healthy Adults

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What is this study about?

This clinical trial is focused on studying the effects of a medication called nerandomilast, which is being tested in healthy adult men and women. The study aims to compare two different formulations of nerandomilast tablets and to see how food affects the new formulation when taken orally. The medication is provided in the form of a film-coated tablet.

The purpose of the study is to understand how the body processes the two formulations of nerandomilast and how food might change this process. Participants will take part in a three-way crossover trial, which means they will receive different formulations of the medication at different times, with and without food. This will help researchers determine the best way to administer the medication for optimal effectiveness.

Throughout the study, participants will be monitored to assess how the medication is absorbed and processed in the body. This will involve measuring the concentration of the medication in the blood over time. The study is designed to ensure the safety and well-being of all participants while gathering important information about the medication’s behavior in the body.

1 initial assessment

Upon joining the study, a complete medical history will be taken. This includes a physical examination, checking vital signs such as blood pressure and pulse rate, performing a 12-lead electrocardiogram (ECG), and conducting clinical laboratory tests.

Eligibility will be confirmed based on criteria such as age (18 to 55 years), body mass index (BMI) between 18.5 and 29.9 kg/m², and overall health status.

2 informed consent

A signed and dated written informed consent is required. This document confirms understanding of the study and agreement to participate, in accordance with international guidelines and local laws.

3 trial participation

The study involves taking two different formulations of the medication nerandomilast, which is provided as a film-coated tablet. The medication is taken orally.

The trial is designed as a single-dose, three-way crossover study. This means that each participant will receive the medication in different sequences, with or without food, to compare the effects.

4 medication administration

Participants will take the medication as instructed, with specific attention to whether it is taken with or without food. The exact dosage and frequency will be provided by the study team.

The study aims to measure how the body absorbs and processes the medication, focusing on the area under the concentration-time curve (AUC) and the maximum concentration (Cmax) of the medication in the blood.

5 follow-up assessments

After taking the medication, follow-up assessments will be conducted to monitor health and gather data on how the medication is processed by the body.

These assessments may include additional blood tests and health checks to ensure safety and gather necessary data for the study.

Who Can Join the Study?

Must be a healthy male or female, as determined by the study doctor. This will be based on a complete medical history, a physical exam, checking vital signs like blood pressure and pulse rate, a heart test called a 12-lead ECG, and lab tests.
Must be between the ages of 18 to 55 years old.
Must have a Body Mass Index (BMI) between 18.5 to 29.9. BMI is a measure of body fat based on height and weight.
Must have signed and dated a written consent form, agreeing to participate in the study, according to international and local laws.
Other criteria may also apply.

Who Cannot Join the Study?

Participants must be healthy volunteers. This means you should not have any ongoing medical conditions.
Participants must be within a specific age range. Please ensure you meet the age requirements for the study.
Both men and women can participate in the study.
Participants should not be part of a vulnerable population. This means you should not be in a group that needs special protection, like pregnant women or people who cannot make decisions for themselves.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Bhaohzqgiq Ifqiecncs Pgptuw Gprz &qvdm Cwc Ko	Biberach	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	14.10.2024

Trial locations

Investigated drugs:

Nerandomilast is a medication being studied to see how it is absorbed in the body when taken in different forms. The trial is also looking at how eating food might change the way the body processes this medication. This study involves healthy adult men and women who take the medication by mouth. The goal is to understand if the new form of the medication works the same way as the original form and how food might affect its effectiveness. This information can help doctors decide the best way to prescribe this medication in the future.

Healthy Volunteer Trial – This is not a disease but a type of clinical study involving individuals who do not have the condition being studied. These participants are typically healthy individuals who volunteer to help researchers understand how a new drug or treatment works in the human body. The trial may involve monitoring the absorption, distribution, metabolism, and excretion of the drug. Healthy volunteer trials are crucial for determining the safety and pharmacokinetics of new treatments before they are tested in patients with the disease. Participants are closely monitored for any side effects or reactions to the treatment. These trials help establish baseline data for future studies involving patients with specific medical conditions.

Trial ID:

2024-511245-18-00

Protocol code:

1305-0029

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Effects of Food on Two Formulations of Nerandomilast in Healthy Adults

What is this study about?

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Who Cannot Join the Study?