Status and phase
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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
Sex
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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:
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
62 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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