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Completed

NCT Number: 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 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).

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

SGS Life Science Services - Clinical Research

Edegem, 2650, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BI 1569912

Drug

Intended dose of BI 1569912

repaglinide

Drug

0.5 mg tablet

midazolam

Drug

2 mg solution for injection

bupropion

Drug

150 mg extended-release tablet

Primary outcomes

  1. Area Under the Concentration-time Curve of Repaglinide in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)

    Time frame: Within 3 hours (h) before repaglinide administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 h thereafter.

    This outcome measured the area under the concentration-time curve of repaglinide in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞), when administered alone and when co-administered at BI 1569912 steady-state.

    The statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.

  2. Area Under Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)

    Time frame: Within 3 hours (h) before midazolam administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 h thereafter.

    This outcome measured the area under the concentration-time curve of midazolam in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞), when administered alone and when co-administered at BI 1569912 steady-state.

    The statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.

  3. Area Under the Concentration-time Curve of S-bupropion in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)

    Time frame: Within 3 hours (h) before bupropion administration and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 h thereafter.

    This outcome measured the area under the concentration-time curve of chiral form S-bupropion in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞), when bupropion was administered alone and when co-administered at BI 1569912 steady-state.

    The statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.

  4. Area Under the Concentration-time Curve of Total Bupropion in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)

    Time frame: Within 3 hours (h) before bupropion administration and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 h thereafter.

    This outcome measured the area under the concentration-time curve of total bupropion in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞), when bupropion was administered alone and when co-administered at BI 1569912 steady-state.

    The statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.

Secondary outcomes

  1. Area Under the Concentration-time Curve of Repaglinide in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)

    Time frame: Within 3 hours (h) before repaglinide administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 h thereafter.

    This outcome measured the area under the concentration-time curve of repaglinide in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz), when administered alone and when co-administered at BI 1569912 steady-state.

    The statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.

  2. Maximum Measured Concentration of Repaglinide in Plasma (Cmax)

    Time frame: Within 3 hours (h) before repaglinide administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 h thereafter.

    This outcome measured maximum measured concentration of repaglinide in plasma (Cmax), when administered alone and when co-administered at BI 1569912 steady-state.

    The statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.

  3. Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)

    Time frame: Within 3 hours (h) before midazolam administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 h thereafter.

    This outcome measured the area under the concentration-time curve of midazolam in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz), when administered alone or co-administered at BI 1569912 steady-state.

    The statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.

  4. Maximum Measured Concentration of Midazolam in Plasma (Cmax)

    Time frame: Within 3 hours (h) before midazolam administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 h thereafter.

    This outcome measured maximum measured concentration of midazolam in plasma (Cmax), when administered alone and when co-administered at BI 1569912 steady-state.

    The statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.

  5. Area Under the Concentration-time Curve of S-bupropion in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)

    Time frame: Within 3 hours (h) before bupropion administration and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 h thereafter.

    This outcome measured the area under the concentration-time curve of the chiral form S-bupropion in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz), when bupropion was administered alone and when co-administered at BI 1569912 steady-state.

    The statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.

  6. Maximum Measured Concentration of S-bupropion in Plasma (Cmax)

    Time frame: Within 3 hours (h) before bupropion administration and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 h thereafter.

    This outcome measured maximum measured concentration of the chiral form S-bupropion in plasma (Cmax), when administered alone and when co-administered at BI 1569912 steady-state.

    The statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.

  7. Area Under the Concentration-time Curve of Total Bupropion in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)

    Time frame: Within 3 hours (h) before bupropion administration and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 h thereafter.

    This outcome measured the area under the concentration-time curve of total bupropion in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz), when bupropion was administered alone and when co-administered at BI 1569912 steady-state.

    The statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.

  8. Maximum Measured Concentration of Total Bupropion in Plasma (Cmax)

    Time frame: Within 3 hours (h) before bupropion administration and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 h thereafter.

    This outcome measured maximum measured concentration of total bupropion in plasma (Cmax), when administered alone and when co-administered at BI 1569912 steady-state.

    The statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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)

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 16, 2024
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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