A Study in Healthy Men to Test How BI 1839100 is Taken up and Handled by the Body

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-30

Study Completion Date

2025-09-02

Brief Summary

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This trial is conducted in healthy male subjects to evaluate the drug BI 1839100. The trial has two main parts. Part A aims to understand how BI 1839100 is processed in the body after an oral dose. It measures the total recovery of the drug and its radioactive label in urine and feces. It also determines the concentrations in blood plasma and investigates the drug's metabolic pathways. Part B aims to compare the absolute bioavailability of BI 1839100 when administered orally and intravenously.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Part A: open-label, single arm, single-dose Part B: non-randomized, open-label, single-arm, single period, fixed sequence, crossover

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part A: BI 1839100 (C-14) formulation 1

BI 1839100 (C-14) = BI 1839100 Carbon 14 Radiolabelled

Group Type EXPERIMENTAL

BI 1839100 (C-14) formulation 1

Intervention Type DRUG

BI 1839100 (C-14) formulation 1

Part B: BI 1839100 followed by BI 1839100 (C-14) formulation 2

Group Type EXPERIMENTAL

BI 1839100

Intervention Type DRUG

BI 1839100

BI 1839100 (C-14) formulation 2

Intervention Type DRUG

BI 1839100 (C-14) formulation 2

Interventions

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BI 1839100 (C-14) formulation 1

Intervention Type DRUG

BI 1839100

Intervention Type DRUG

BI 1839100 (C-14) formulation 2

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. 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)), 12-lead electronic cardiogram (ECG), and clinical laboratory tests.
2. Age of 18 to 59 years (inclusive at screening)
3. Body mass index (BMI) of 18.5 to 30.0 kg/m2 (inclusive at screening)
4. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial

Exclusion Criteria

1. Any finding in the medical examination (including blood pressure (BP), pulse rate (PR), or ECG that deviates from normal and is assessed as clinically significant by the investigator
2. Repeated measurement of systolic BP outside the range of 90 to 140 mmHg, diastolic BP outside the range of 50 to 90 mmHg, or PR outside the range of 45 to 90 bpm (subjects with PR values between 45 and 50 bpm may only be enrolled in case they have normal thyroid function (thyroid-stimulating hormone (TSH) and free thyroxine (FT4) at baseline-screening, no clinical symptoms associated with the bradycardia and no apparent signs of other diseases causing bradycardia such as hypothyroidism or heart conduction abnormalities)
3. Any laboratory value outside the reference range that the investigator considers to be of clinical significance
4. Any evidence of a concomitant disease assessed as clinically significant by the investigator
5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders assessed as clinically significant by the investigator
6. Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the Pharmacokinetics (PKs) of the trial medication (except appendectomy or simple hernia repair)
7. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders assessed as clinically relevant by the investigator

Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes