A Study to Test How Healthy Women Tolerate Different Doses of BI 1819479

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Boehringer Ingelheim

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: BI 1819479
Drug: BI matching placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT05440799
1462-0002
2021-006992-41 (EudraCT Number)

Details and patient eligibility

About

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 1819479 in healthy female subjects of non-childbearing potential.

Enrollment

62 patients

Sex

Female

Ages

18 to 67 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy female subjects of non-childbearing potential 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 between 18 years and 67 (inclusive)
  • Body mass index (BMI) of 18.5 to 30.9 (weight divided by height squared)(kg/m2) (inclusive)
  • Signed and dated written informed consent in accordance with International Conference on Harmonisation (ICH) - Good Clinical Practice (GCP) and local legislation prior to admission to the trial

Female subject of non-childbearing potential defined as:

  • Permanently surgically sterilised (hysterectomy, bilateral salpingectomy and/or bilateral oophorectomy)
  • Postmenopausal, defined as no menses for 1 year in women aged = 51 years or no menses for 2 years in women aged = 50 years, without an alternative medical cause

In questionable cases of postmenopausal status:

  • Women not using sex hormone medication such as hormone replacement therapy may be included if a blood sample confirms levels of Follicle-stimulating hormone (FSH) > 40 unit/liter (U/L) and estradiol < 30 nanogram per liter (ng/L)
  • Women using sex hormone medication such as hormone replacement therapy cannot be included in the trial

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
  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Quadruple Blind

62 participants in 2 patient groups, including a placebo group

BI 1819479
Experimental group
Treatment:
Drug: BI 1819479
Placebo
Placebo Comparator group
Treatment:
Drug: BI matching placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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