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

NCT04445090 | Terminated Phase 1

• 2 other identifiers: 1447-00012019-004836-51
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• SRD-part: % of subjects with drug-related adverse events

  up to 14 days

• 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

• BA/FE-part: Cmax (maximum measured concentration of BI 1569912 in plasma)

  up to 4 days

Secondary Outcomes (3)

• 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

• SRD-Part: Cmax (maximum measured concentration of BI 1569912 in plasma)

  up to 4 days

• 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

Study Arms (3)

Single Rising Dose part: BI 1569912

EXPERIMENTAL

Drug: BI 1569912

Single Rising Dose part: Placebo

PLACEBO COMPARATOR

Drug: Placebo

Bioavailability and Food effect part: BI 1569912

EXPERIMENTAL

This part follows the SRD part; open-label, randomised, single-dose, intraindividual, six-sequence, three-way crossover

Drug: BI 1569912

Interventions

BI 1569912 DRUG

BI 1569912

Bioavailability and Food effect part: BI 1569912; Single Rising Dose part: BI 1569912

Placebo DRUG

Placebo

Single Rising Dose part: Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Related Links

• Related Info

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: SRD-Part: parallel-group design BA/FE-Part: three-way crossover design

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: June 24, 2020
• Study Start: July 21, 2020
• Primary Completion: September 10, 2021
• Study Completion: September 10, 2021
• Last Updated: November 12, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)