A Study in Healthy Men to Test How Well Different Doses of BI 1839100 Are Tolerated (1490-0001)

Healthy Clinical Trial

Official title:

Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses of BI 1839100 in Healthy Male Subjects (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05354453
• Other study ID #: 1490-0001
• Secondary ID: 2021-006294-27
• Status: Completed
• Phase: Phase 1
• Start date: May 23, 2022
• Est. completion date: June 14, 2023

Study information

• Verified date: June 2023
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial starts the clinical development of BI 1839100. Effects of single rising doses of BI 1389100 on safety, tolerability and pharmacokinetics will be assessed as basis for further development in patients with pulmonary fibrosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: June 14, 2023
• Est. primary completion date: June 14, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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)), 12-lead electrocardiogram (ECG), and clinical laboratory tests

• Age of 18 to 45 years (inclusive)

• Body mass index (BMI) of 18.5 to 31.9 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

• Male subjects who meet any of the following criteria for a highly effective contraception from the first administration of trial medication until 90 days after trial completion:

• Willing to use a medically accepted method of contraception. Acceptable methods of contraception for use by male subjects include sexual abstinence, a vasectomy performed at least 1 year prior to dosing, and barrier contraception (condom)

• Subjects who are not vasectomised or sexually abstinent have to ensure that an additional acceptable method of contraception (in addition to male condom) will be used by his female partner such as intrauterine device (IUD), surgical sterilisation (including hysterectomy), hormonal contraception (e.g. implants, injectables, combined oral or vaginal contraceptives) that started at least 2 month prior to drug administration or postmenopausal status of female partner (defined as no menses for 1 year without an alternative medical cause (in questionable cases a blood sample with follicle stimulating hormone (FSH) above 40 U/L and estradiol below 30 ng/L is confirmatory)

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 bpm (subjects with heart rate values between 45 and 50 bpm may only be enrolled in case they have a normal thyroid function, no clinical symptoms associated with the bradycardia and no apparent signs of other diseases causing bradycardia such as hypothyroidism or heart conduction abnormalities)

• 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

• History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• BI 1839100
BI 1839100
• Placebo
Placebo
• allyl isothiocyanate (AITC)
allyl isothiocyanate (AITC)

Locations

Country	Name	City	State
Netherlands	Centre Human Drug Research	Leiden

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator		up to 10 days
Secondary	Area under the concentration-time curve of BI 1839100 in plasma over the time interval from 0 extrapolated to infinity (AUC0-8)		up to 4 days
Secondary	Maximum measured concentration of BI 1839100 in plasma (Cmax)		up to 4 days
Secondary	Time from dosing to maximum measured concentration of BI 1839100 in plasma (tmax)		up to 4 days

External Links

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