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

Last updated: November 12, 2024
Sponsor: Boehringer Ingelheim
Overall Status: Completed

Phase

1

Condition

N/A

Treatment

repaglinide

midazolam

bupropion

Clinical Study ID

NCT06367153
1447-0007
U1111-1303-9187
2023-510461-10-00
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Healthy male or female subjects according to the assessment of the investigator, asbased on a complete medical history including a physical examination, standardizedmental and neurological assessment, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests withoutclinically 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 Councilfor Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior toadmission to the trial

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

  • Use of adequate contraception, i.e. use of condom (male subjects or malepartners of female subjects) plus any of the following methods (female subjectsor female partners of male subjects): intrauterine device, hormonalcontraception (e.g. implants, injectables, combined oral or vaginalcontraceptives), , surgically sterilised (including bilateral tubalocclusion/ligation, hysterectomy, bilateral oophorectomy) or postmenopausal,defined as no menses for 1 year without an alternative medical cause (inquestionable 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 asrefraining from heterosexual intercourse during the entire period of riskassociated with the study treatments)

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

Exclusion

Exclusion Criteria:

  • Any finding in the medical examination (including BP, PR or ECG) deviating fromnormal and assessed as clinically relevant by the investigator

  • Repeated measurement of systolic blood pressure outside the range of 90 to 140millimetre(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 tobe 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 theinvestigator

  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,immunological or hormonal disorders

  • Cholecystectomy or other surgery of the gastrointestinal tract that could interferewith the pharmacokinetics of the trial medication (except appendectomy or simplehernia repair)

  • Diseases of the central nervous system (including but not limited to any kind ofseizures or stroke, bulimia or anorexia, or bipolar mood disorder), and otherrelevant neurological or psychiatric disorders

  • History of relevant orthostatic hypotension, fainting spells, or blackouts Furtherexclusion criteria apply.

Study Design

Total Participants: 18
Treatment Group(s): 4
Primary Treatment: repaglinide
Phase: 1
Study Start date:
May 15, 2024
Estimated Completion Date:
August 20, 2024

Connect with a study center

  • SGS Life Science Services - Clinical Research

    Edegem, 2650
    Belgium

    Site Not Available

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