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

Healthy Clinical Trial

Official title:

Safety, Tolerability and Pharmacokinetics of Multiple Rising Oral Doses of BI 1819479 in Healthy Female Subjects of Non-childbearing Potential (Double-blind, Randomised, Placebo-controlled, Parallel Group Design)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05440799
• Other study ID #: 1462-0002
• Secondary ID: 2021-006992-41
• Status: Completed
• Phase: Phase 1
• Start date: July 20, 2022
• Est. completion date: August 2, 2023

Study information

• Verified date: August 2023
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: August 2, 2023
• Est. primary completion date: August 2, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 67 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• BI 1819479
BI 1819479
• BI matching placebo
BI matching placebo

Locations

Country	Name	City	State
Germany	CRS Clinical Research Services Mannheim GmbH	Mannheim

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator		up to 106 days
Secondary	Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t (AUCt,ss)		up to 92 days
Secondary	Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t (Cmax,ss)		up to 92 days

External Links

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