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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

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Boehringer Ingelheim

Status and phase

Terminated
Phase 1

Conditions

Healthy

Treatments

Drug: BI 1569912
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT04445090
2019-004836-51 (EudraCT Number)
1447-0001

Details and patient eligibility

About

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

Enrollment

68 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

68 participants in 3 patient groups, including a placebo group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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