A Study in Healthy People to Compare How 2 Different Low Dose Formulations of BI 1015550 Are Taken up in the Body

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BI 1015550

Study type: Interventional

Funder types: Industry

Identifiers

NCT06408870

U1111-1301-0913 (Registry Identifier)

2023-509951-15-00 (Registry Identifier)

1305-0051

Details and patient eligibility

About

The main objective of this trial is to establish the bioequivalence of the BI 1015550 Formulation C2 (Test, T) and the BI 1015550 Formulation C1 (Reference, R) following a single oral dose administration.

Enrollment: 64 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male or female subject 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 50 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
• Female subject who meets any of the following criteria for a highly effective contraception from at least 30 days before the first administration of trial medication until 7 days after last administration

Highly effective methods of contraception include:

• Use of oral hormonal contraception that prevents ovulation, plus condom

• Use of combined (estrogen and progestogen-containing) hormonal contraception that prevents ovulation (intravaginal or transdermal)

• Use of progestogen-only hormonal contraception that inhibits ovulation (only injectables or implants)

• Use of intrauterine device (IUD) or intrauterine hormone-releasing system (IUS)

• Sexually abstinent is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.

• Bilateral tubal occlusion

  - Women not of childbearing potential (WNOCBP) include:

• Permanently surgically sterilised (including hysterectomy, bilateral oophorectomy and bilateral salpingectomy)

• 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) WNOCBP are not required to use any methods of contraception. For in vitro fertilization (IVF) and in foreign countries, female subjects should not participate in egg donation and male subjects should not participate in sperm donation from the first study drug administration, for the duration of the study and for at least 7 days after the last study drug administration.

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) at screening
• 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) at screening
• Any evidence of a concomitant disease assessed as clinically relevant by the investigator
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders assessed as clinically relevant by the investigator
• 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 depression and suicidal behaviour
• History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

BI 1015550 Formulation C1 (Reference, R) then BI 1015550 Formulation C2 (Test, T)

Experimental group

Description:

For this two period crossover study arm, participants received treatment in the following order: Participants received a single oral dose of nerandomilast (BI 1015550), a low dose film coated tablet (formulation C1, titanium dioxide \[TiO2\]-containing phase III formulation, reference (R)) with 240 mL water after an overnight fast of at least 10 h (period 1). Participants received a single oral dose of nerandomilast (BI 10105550), a low dose film coated tablet (formulation C2, titanium dioxide \[TiO2\] free, test (T)) with 240 mL water after an overnight fast of at least 10 h (period 2). In between the treatment periods, participants went through a washout period of 10 days.

Treatment:

Drug: BI 1015550

BI 1015550 Formulation C2 (Test, T) then BI 1015550 Formulation C1 (Reference, R)

Experimental group

Description:

For this two period crossover study arm, participants received treatment in the following order: Participants received a single oral dose of nerandomilast (BI 10105550), a low dose film coated tablet (formulation C2, titanium dioxide \[TiO2\] free, test (T)) with 240 mL water after an overnight fast of at least 10 h (period 1). Participants received a single oral dose of nerandomilast (BI 1015550), a low dose film coated tablet (formulation C1, titanium dioxide \[TiO2\]-containing phase III formulation, reference (R)) with 240 mL water after an overnight fast of at least 10 h (period 2). In between the treatment periods, participants went through a washout period of 10 days.

Treatment:

Drug: BI 1015550