- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06367153
A Study in Healthy Men and Women to Test Whether BI 1569912 Influences the Amount of Repaglinide, Midazolam and Bupropion in the Blood
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)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Boehringer Ingelheim
- Phone Number: 1-800-243-0127
- Email: clintriage.rdg@boehringer-ingelheim.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: repaglinide + midazolam + bupropion then BI 1569912 + repaglinide + midazolam + bupropion
repaglinide + midazolam + bupropion (reference treatment, R) then BI 1569912 + repaglinide + midazolam + bupropion (test treatment, T)
|
BI 1569912
midazolam
repaglinide
bupropion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Time Frame: up to 30 days
|
up to 30 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
Time Frame: up to 30 days
|
up to 30 days
|
Maximum measured concentration of the analyte in plasma (Cmax)
Time Frame: up to 30 days
|
up to 30 days
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Enzyme Inhibitors
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Tranquilizing Agents
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Dopamine Agents
- Hypnotics and Sedatives
- Adjuvants, Anesthesia
- Anti-Anxiety Agents
- GABA Modulators
- GABA Agents
- Cytochrome P-450 Enzyme Inhibitors
- Antidepressive Agents, Second-Generation
- Cytochrome P-450 CYP2D6 Inhibitors
- Dopamine Uptake Inhibitors
- Midazolam
- Bupropion
- Repaglinide
Other Study ID Numbers
- 1447-0007
- 2023-510461-10-00 (Registry Identifier: CTIS)
- U1111-1303-9187 (Registry Identifier: WHO International Clinical Trials Registry Platform (ICTRP))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to:
https://www.mystudywindow.com/msw/datatransparency
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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