A Study in Healthy Men and Women to Test Whether BI 1569912 Influences the Amount of Repaglinide, Midazolam and Bupropion in the Blood

Healthy Clinical Trial

Official title:

The Effect of Multiple Doses of BI 1569912 on the Single-dose Pharmacokinetics of Repaglinide, Midazolam and Bupropion Following Oral Administration in Healthy Male and Female Subjects (an Open-label, 2-period Fixed-sequence Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06367153
• Other study ID #: 1447-0007
• Secondary ID: 2023-510461-10-0
• Status: Recruiting
• Phase: Phase 1
• Start date: May 7, 2024
• Est. completion date: August 24, 2024

Study information

• Verified date: May 2024
• Source: Boehringer Ingelheim
• Contact: Boehringer Ingelheim
• Phone: 1-800-243-0127
• Email: clintriage.rdg[@]boehringer-ingelheim.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective of this trial is to investigate the effect of multiple oral doses of BI 1569912 on the pharmacokinetics of a single oral dose of repaglinide, midazolam and bupropion (i.e. sensitive CYP2C8, CYP3A4 and CYP2B6 substrates).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: August 24, 2024
• Est. primary completion date: August 24, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy male or female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, standardized mental and neurological assessment, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests without clinically significant abnormalities

• Age of 18 to 55 years (inclusive)

• Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)

• Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial

• Either male subjects or female subjects who meet the following criteria requiring highly effective contraception from at least 30 days before the first administration of trial medication until 30 days after trial completion:

• Use of adequate contraception, i.e. use of condom (male subjects or male partners of female subjects) plus any of the following methods (female subjects or female partners of male subjects): intrauterine device, hormonal contraception (e.g. implants, injectables, combined oral or vaginal contraceptives), , surgically sterilised (including bilateral tubal occlusion/ligation, hysterectomy, bilateral oophorectomy) or postmenopausal, defined as no menses for 1 year without an alternative medical cause (in questionable cases a blood sample with levels of Follicle stimulating hormone (FSH) above 40 U/L is confirmatory)

• Sexually abstinent (considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments)

• Vasectomised male subjects or male partners of female subjects (vasectomy at least 1 year prior to enrolment) in combination with a barrier method (i.e. use of condom) and provided that the partner is the sole sexual partner of the trial participant Unprotected sexual intercourse (i.e. without use of condom) of a male subject with a pregnant female partner and sperm donation is not allowed throughout the study and until 30 days after trial completion. Female subjects should not participate in egg donation from the first trial medication administration, for the duration of the study and for at least 30 days after trial completion.

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 millimetre(s) 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, 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)

• Diseases of the central nervous system (including but not limited to any kind of seizures or stroke, bulimia or anorexia, or bipolar mood disorder), 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 1569912
BI 1569912
• repaglinide
repaglinide
• midazolam
midazolam
• bupropion
bupropion

Locations

Country	Name	City	State
Belgium	SGS Life Science Services - Clinical Research	Edegem

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-8)		up to 30 days
Secondary	Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)		up to 30 days
Secondary	Maximum measured concentration of the analyte in plasma (Cmax)		up to 30 days

External Links

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