A Study to Test How Different Doses of Nerandomilast (BI 1015550) Are Taken up in the Body of Healthy Japanese Men

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

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-20

Study Completion Date

2024-02-13

Brief Summary

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

The main objectives of this trial are to investigate pharmacokinetics (PK) of R-BI 1015550 in Japanese healthy male subjects following oral administration of two different single BI 1015550 doses.

Related Clinical Trials

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

This Study Tests How Healthy Men Tolerate Different Doses of BI1015550. The Study Also Tests How BI 1015550 is Taken up by the Body

NCT03230487

Healthy

COMPLETED PHASE1

A Study in Healthy Chinese People to Test How Different Doses of BI 1015550 Are Taken up in the Body

NCT05633862

Healthy

COMPLETED PHASE1

Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1015550 in Healthy Male Volunteers

NCT01594515

Healthy

COMPLETED PHASE1

Safety, Tolerability and Pharmacokinetics of Multiple Rising Oral Doses of BI 1015550 Powder for Oral Solution

NCT01835899

Healthy

COMPLETED PHASE1

A Study in Healthy Men to Test How BI 1015550 is Taken up and Handled by the Body

NCT05707403

Healthy

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

NON_RANDOMIZED

Intervention Model

PARALLEL

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 9 mg

Participants were administered a single film-coated tablet of 9 mg of nerandomilast (Formulation C1), orally with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h).

Group Type EXPERIMENTAL

Nerandomilast

Intervention Type DRUG

Participants were administered a single film-coated tablet of nerandomilast (Formulation C1), orally with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h).

Nerandomilast 18 mg

Participants were administered a single film-coated tablet of 18 mg of nerandomilast (Formulation C1), orally with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h).

Group Type EXPERIMENTAL

Nerandomilast

Intervention Type DRUG

Participants were administered a single film-coated tablet of nerandomilast (Formulation C1), orally with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h).

Interventions

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

Nerandomilast

Participants were administered a single film-coated tablet of nerandomilast (Formulation C1), orally with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h).

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®

Eligibility Criteria

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

Inclusion Criteria

* Healthy male 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), Respiratory rate (RR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 to 45 years (inclusive)
* Body mass index (BMI) of 18.5 to 25 kg/m2 (inclusive)
* Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial

Exclusion Criteria

* Any finding in the medical examination (including BP, PR, RR 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 millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 40 to 90 mmHg, or PR outside the range of 40 to 99 beats per minute (bpm)
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes