A Study in Healthy People to Compare 2 Different Formulations of Nerandomilast Tablets When Taken With or Without Food

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-15

Study Completion Date

2024-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The main objective of this trial is to investigate two different formulations of nerandomilast and the effect of food on the pharmacokinetics of the new formulation following oral administration.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Bioequivalence Study of Meloxicam Tablets 15 mg of Dr.Reddy's Laboratories Limited Under Fasting Condition

NCT01161134

Healthy

COMPLETED PHASE1

Influence of Food on the Bioavailability of Telmisartan / Ramipril Fixed Dose Combination in Healthy Male and Female Volunteers

NCT02214966

Healthy

COMPLETED PHASE1

Influence of Food on the Bioavailability of Telmisartan/Amlodipine Fixed Dose Combination in Healthy Japanese Male Volunteers

NCT02261064

Healthy

COMPLETED PHASE1

Bioavailability Study of Anastrozole Tablets 1 mg of Dr.Reddy's Under Fasting Conditions

NCT01155947

Healthy

COMPLETED PHASE1

Bioavailability Study of Fexofenadine HCl New Formulation Tablet

NCT06284902

Healthy Volunteers

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nerandomilast (18 mg) in treatment sequence R-T1-T2

Participants first received a single oral dose of 1 tablet of 18 milligrams (mg) nerandomilast adult formulation in the fasted state (Reference treatment, R), followed by a single oral dose of 18 tablets of 1 mg nerandomilast pediatric formulation in the fasted state (Treatment, T1), and then 18 tablets of 1 mg of nerandomilast pediatric formulation in the fed state as a single oral dose (Treatment, T2).

Treatments were separated by a wash-out period of at least 7 days and treatments were taken with 240 mL of water after an overnight fast of at least 10 hours (hrs) for R and T1, or after a high-fat, high-calorie breakfast for T2.

Group Type EXPERIMENTAL

Nerandomilast 18 mg - adult formulation

Intervention Type DRUG

BI 1015550, oral tablet

Nerandomilast 1 mg - paediatric formulation

Intervention Type DRUG

BI 1015550, oral tablet

Nerandomilast (18 mg) in treatment sequence T1-T2-R

Participants first received a single oral dose of 18 tablets of 1 mg nerandomilast pediatric formulation in the fasted state (T1), followed by a single oral dose of 18 tablets of 1 mg nerandomilast pediatric formulation in the fed state (T2), and then a single oral dose of 18 mg of nerandomilast adult formulation in the fasted state (R).

Treatments were separated by a wash-out period of at least 7 days and treatments were taken with 240 mL of water after an overnight fast of at least 10 hrs for R and T1, or after a high-fat, high-calorie breakfast for T2.

Group Type EXPERIMENTAL

Nerandomilast 18 mg - adult formulation

Intervention Type DRUG

BI 1015550, oral tablet

Nerandomilast 1 mg - paediatric formulation

Intervention Type DRUG

BI 1015550, oral tablet

Nerandomilast (18 mg) in treatment sequence T2-R-T1

Participants first received a single oral dose of 18 tablets of 1 mg nerandomilast pediatric formulation in the fed state (T2), followed by a single oral dose of 18 mg of nerandomilast adult formulation in the fasted state (R), and then a single oral dose of 18 tablets of 1 mg nerandomilast pediatric formulation in the fasted state (T1).

Treatments were separated by a wash-out period of at least 7 days and treatments were taken with 240 mL of water after an overnight fast of at least 10 hrs for R and T1, or after a high-fat, high-calorie breakfast for T2.

Group Type EXPERIMENTAL

Nerandomilast 18 mg - adult formulation

Intervention Type DRUG

BI 1015550, oral tablet

Nerandomilast 1 mg - paediatric formulation

Intervention Type DRUG

BI 1015550, oral tablet

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nerandomilast 18 mg - adult formulation

BI 1015550, oral tablet

Intervention Type DRUG

Nerandomilast 1 mg - paediatric formulation

BI 1015550, oral tablet

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

BI 1015550, JASCAYD® BI 1015550, JASCAYD®

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy male or female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 to 55 years (inclusive)
* Body mass index (BMI) of 18.5 to 29.9 kg/m² (inclusive)

Exclusion Criteria

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm)
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes