A Study in Healthy Men to Test How Well Different Doses of BI 1569912 Are Tolerated and How Food Influences the Amount of BI 1569912 in the Blood

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT04445090
• Collaborator: (none)
• Enrollment: 68
• Location: 1
• Arms: 3
• Actual Duration (Months): 13.7
• Patients Per Site Per Month: 5

Study Details

Study Description

Brief Summary

SRD-Part: To investigate safety, tolerability, pharmacokinetics and pharmacodynamics following single rising doses (SRD) of BI 1569912 BA/FE-Part: To investigate (a) the relative bioavailability (BA) of BI 1569912 and (b) the influence of food (FE) on the relative bioavailability of BI 1569912

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 68 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: SRD-Part: parallel-group design BA/FE-Part: three-way crossover designSRD-Part: parallel-group design BA/FE-Part: three-way crossover design
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 1569912 in Healthy Male Subjects (Single-blind, Partially Randomized Within Dose Groups, Placebo-controlled, Parallel-group Design) With an Additional Relative Bioavailability/ Food Effect Part (Open-label, Randomized, Three-way Crossover Design)
• Actual Study Start Date: Jul 21, 2020
• Actual Primary Completion Date: Sep 10, 2021
• Actual Study Completion Date: Sep 10, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single Rising Dose part: BI 1569912	Drug: BI 1569912; BI 1569912
Placebo Comparator: Single Rising Dose part: Placebo	Drug: Placebo; Placebo
Experimental: Bioavailability and Food effect part: BI 1569912 This part follows the SRD part; open-label, randomised, single-dose, intraindividual, six-sequence, three-way crossover	Drug: BI 1569912; BI 1569912

Outcome Measures

Primary Outcome Measures

1. SRD-part: % of subjects with drug-related adverse events [up to 14 days]

2. BA/FE-part: AUC0-tz (area under the concentration-time curve of BI 1569912 in plasma over the time interval from 0 to the last quantifiable data point) [up to 4 days]

3. BA/FE-part: Cmax (maximum measured concentration of BI 1569912 in plasma) [up to 4 days]

Secondary Outcome Measures

1. SRD-Part: AUC0-∞ (area under the concentration-time curve of BI 1569912 in plasma over the time interval from 0 extrapolated to infinity) [up to 4 days]

2. SRD-Part: Cmax (maximum measured concentration of BI 1569912 in plasma) [up to 4 days]

3. BA/FE-Part: AUC0-∞ (area under the concentration-time curve of BI 1569912 in plasma over the time interval from 0 extrapolated to infinity) [up to 4 days]

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), respiratory rate (RR), temperature (T)), 12-lead ECG, and clinical laboratory tests

• Age of 18 to 45 years (inclusive)

• 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 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 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)

• History of relevant orthostatic hypotension, fainting spells, or any unexplained blackouts

• Chronic or relevant acute infections

• A positive polymerase chain reaction (PCR) test for SARS-CoV-2/COVID-19 and/ or any clinical symptom suggestive for this disease at screening and on Day -3.

Further exclusion criteria apply.

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: NCT04445090
• Other Study ID Numbers: 1447-0001; 2019-004836-51
• First Posted: Jun 24, 2020
• Last Update Posted: Nov 12, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Nov 12, 2021