A Study in Healthy Men to Test How Well Different Doses of BI 1569912 Are Tolerated

Sponsor

Boehringer Ingelheim (Industry)

Overall Status

Suspended

CT.gov ID

NCT04978506

Collaborator

(none)

Enrollment

Location

Arms

22.8

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main objectives of this trial are to investigate (1) safety, tolerability, pharmacokinetics and pharmacodynamics following multiple rising doses of BI 1569912; (2) tolerability of BI 1569912 in an up-titrating dosing scheme.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: BI 1569912 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Rising Oral Doses of BI 1569912 (Single-blind, Partially Randomized Within Dose Groups, Placebo-controlled, Parallel Group Design) With an Optional Posology (Uptitration) Part (Single-blind, Partially Randomized Within Dose Groups, Placebo-controlled, Parallel Group Design) in Healthy Male Subjects

Actual Study Start Date :

Aug 11, 2021

Anticipated Primary Completion Date :

Jul 7, 2023

Anticipated Study Completion Date :

Jul 7, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BI 1569912 MRD: treatment group 1 Multiple rising dose (MRD) part	Drug: BI 1569912 BI 1569912
Experimental: BI 1569912 POSO treatment group Posology part (optional)	Drug: BI 1569912 BI 1569912
Placebo Comparator: Placebo	Drug: Placebo Placebo
Experimental: BI 1569912 MRD: treatment group 2 Multiple rising dose (MRD) part	Drug: BI 1569912 BI 1569912
Experimental: BI 1569912 MRD: treatment group 3 Multiple rising dose (MRD) part	Drug: BI 1569912 BI 1569912
Experimental: BI 1569912 MRD: treatment group 4 Multiple rising dose (MRD) part	Drug: BI 1569912 BI 1569912

Outcome Measures

Primary Outcome Measures

Percentage of subjects with drug-related adverse events [Up to Day 27]

Secondary Outcome Measures

Area under the concentration-time curve of the analyte in plasma over a uniform dosing interval of 24 h after administration of the first dose (AUC0-24) [At Day 1]
After the first dose
Maximum measured concentration of the analyte in plasma after the first dose (Cmax) [At Day 1]
After the first dose
Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) [Up to Day 17]
After the last dose
Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss) [Up to Day 17]
After the last dose
Minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss) [Up to Day 17]
After the last dose
Accumulation ratio based on Cmax,ss (RA,Cmax) [Up to Day 17]
After the last dose
Accumulation ratio based on AUC0-τ (RA,AUC) [Up to Day 17]
After the last dose

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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 29.9 kg/m2 (inclusive)
Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation
Male subjects who meet any of the following criteria from at least 30 days before the first administration of trial medication until 30 days after trial completion:
Use of adequate contraception, e.g. any of the following methods (of female partners) plus condom: implants, injectables, combined oral or vaginal contraceptives, intrauterine device
Sexually abstinent
Surgically sterilised (including hysterectomy of female partner)
Postmenopausal female partner, defined as at least 1 year of spontaneous amenorrhea (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 millimetres of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm)
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance, in particular, hepatic parameters (alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin) or renal parameters (creatinine) exceeding the upper limit of normal (ULN) after repeated measurements
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/ convulsions or stroke), and other relevant neurological or psychiatric disorders
History of relevant orthostatic hypotension, fainting spells, or unexplained blackouts

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Charité - Universitätsmedizin Berlin	Berlin		Germany	10117

Sponsors and Collaborators

Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Related Info

Publications

None provided.

Responsible Party:

Boehringer Ingelheim

ClinicalTrials.gov Identifier:

NCT04978506

Other Study ID Numbers:

1447-0002
2021-001717-36

First Posted:

Jul 27, 2021

Last Update Posted:

Aug 10, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 10, 2022