A Study in Healthy People to Compare 2 Different Formulations of BI 1015550 Taken With or Without Food

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 1015550 ICF; Drug: BI 1015550 TF2

• Registration Number: NCT05428436
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The main objective of this trial is to investigate the relative bioavailability of BI 1015550 intended Commercial Formulation (iCF) compared with Trial Formulation 2 (TF2) and the effect of food on the pharmacokinetics of BI 1015550 iCF following oral administration.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-17
• Study First Submitted QC: 2022-06-17
• Study First Posted: 2022-06-23
• Study Start: 2022-08-15
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-04
• Last Update Posted: 2022-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests.

• 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 subject, or female subject who meet any of the following criteria from 30 days before drug administration until 7 days after trial completion:

  • Use of non-oral hormonal contraception associated with inhibition of ovulation:

intravaginal or transdermal combinations of estrogen and progestogen or injectable or implantable progestogen.

• Use of intrauterine device (IUD) or intrauterine hormone-releasing system (IUS).
• Sexually abstinent, i.e. complete abstinence from male-female sex when this is in line with the preferred and usual lifestyle of the study participant. Periodic abstinence e.g. calendar, ovulation, symptothermal, post-ovulation methods; declaration of abstinence for the duration of exposure to study drug; and withdrawal are not acceptable.
• Vasectomised sexual partner with appropriate post-vasectomy documentation of the absence of sperm in the ejaculate, provided that partner is the sole sexual partner of the study participant
• Surgically sterilised (including hysterectomy, bilateral salpingectomy, bilateral oophorectomy, bilateral tubal occlusion).
• 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 and estradiol below 30 ng/L is confirmatory).

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 of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 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 (including but not limited to major depressive disorder or history of suicide attempts).
• History of relevant orthostatic hypotension, fainting spells, or blackouts. Further exclusion criteria apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BI 1015550 TF2 fasted/BI 1015550 iCF fasted/BI 1015550 iCF fed	BI 1015550 ICF	-
BI 1015550 TF2 fasted/BI 1015550 iCF fasted/BI 1015550 iCF fed	BI 1015550 TF2	-
T1 BI 1015550 iCF fasted/BI 1015550 iCF fed/BI 1015550 TF2 fasted	BI 1015550 ICF	-
T1 BI 1015550 iCF fasted/BI 1015550 iCF fed/BI 1015550 TF2 fasted	BI 1015550 TF2	-
BI 1015550 iCF fed/BI 1015550 TF2 fasted/BI 1015550 iCF fasted	BI 1015550 ICF	-
BI 1015550 iCF fed/BI 1015550 TF2 fasted/BI 1015550 iCF fasted	BI 1015550 TF2	-

Primary Outcome Measures

Name	Time	Method
Maximum measured concentration of the analyte in plasma (Cmax)	Up to 144 hours.
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 144 hours.

Secondary Outcome Measures

Name	Time	Method
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)	Up to 144 hours.

Trial Locations

Locations (1)

Humanpharmakologisches Zentrum Biberach; 🇩🇪 Biberach, Germany