This Study Tests How Healthy Men Tolerate Different Doses of BI 730357 and How the Metabolism of Midazolam is Affected by BI 730357

NCT ID: NCT03279978

Last Updated: 2024-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-09
• Study Completion Date: 2018-08-30

Brief Summary

Phase Ib evaluation of the safety, tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) properties of Multiple Rising Dose (MRD) administration of BI 730357 to healthy volunteers for up to 28 days.

Conditions

Healthy; Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BI 730357 25 mg fast

Subjects were orally administered BI 730357 25 mg, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours

Group Type: EXPERIMENTAL

BI 730357

Intervention Type: DRUG

BI 730357 film-coated tablet

Placebo fast

Subjects were orally administered matching Placebo to BI 730357, film-coated tablet after a fasting period of at least 6 hours.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Placebo fed

Subjects were orally administered matching Placebo to BI 730357, film-coated tablet after the intake of a standard continental breakfast.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

BI 730357 50 mg fast

Subjects were orally administered BI 730357 50 mg, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours.

Group Type: EXPERIMENTAL

BI 730357

Intervention Type: DRUG

BI 730357 film-coated tablet

BI 730357 50mg/Placebo

Subject was orally administered mixed treatment of BI 730357 50 mg and placebo, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours

Group Type: EXPERIMENTAL

BI 730357

Intervention Type: DRUG

BI 730357 film-coated tablet

Placebo

Intervention Type: DRUG

Placebo

BI 730357 50 mg fed

Subjects were orally administered BI 730357 50 mg, film-coated tablet once daily over 14 days after the intake of a standard continental breakfast.

Group Type: EXPERIMENTAL

BI 730357

Intervention Type: DRUG

BI 730357 film-coated tablet

BI 730357 100 mg fast

Subjects were orally administered BI 730357 100 mg, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours

Group Type: EXPERIMENTAL

BI 730357

Intervention Type: DRUG

BI 730357 film-coated tablet

BI 730357 200 mg fast

Subjects were orally administered BI 730357 200 mg, film-coated tablet once daily over 28 days after a fasting period of at least 6 hours

Group Type: EXPERIMENTAL

BI 730357

Intervention Type: DRUG

BI 730357 film-coated tablet

BI 730357 200 mg fed

Subjects were orally administered a microdose of midazolam 75 microgram (75 μg) solution for injection, orally on Day -1, and prior receiving BI 730357 on Days 3, and 14. Subjects were orally administered BI 730357 200 mg, film-coated tablet once daily over 28 days after the intake of a standard continental breakfast.

Group Type: EXPERIMENTAL

BI 730357

Intervention Type: DRUG

BI 730357 film-coated tablet

Midazolam

Intervention Type: DRUG

Once per day (QD) on Days -1, 3, and 14. Dose groups BI 730357 200 mg fed and BI 730357 400 mg fed

BI 730357 400 mg fed

Subjects were orally administered a microdose of midazolam 75 microgram (75 μg) solution for injection, orally on Day -1, and prior receiving BI 730357 on Days 3, and 14. Subjects were orally administered BI 730357 400 mg, film-coated tablet once daily over 28 days after the intake of a standard continental breakfast.

Group Type: EXPERIMENTAL

BI 730357

Intervention Type: DRUG

BI 730357 film-coated tablet

Midazolam

Intervention Type: DRUG

Once per day (QD) on Days -1, 3, and 14. Dose groups BI 730357 200 mg fed and BI 730357 400 mg fed

Interventions

BI 730357

BI 730357 film-coated tablet

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Midazolam

Once per day (QD) on Days -1, 3, and 14. Dose groups BI 730357 200 mg fed and BI 730357 400 mg fed

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy male subjects according to the assessment of the Investigator, based on a complete medical history, physical examination, vital signs (blood pressure, pulse rate), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
• Subjects with a partner who is a woman of childbearing potential (WOCBP) must be willing to use male contraception (condom or sexual abstinence) from the first administration of trial medication until 30 days after last administration of trial medication
• Age of 18 to 45 years (incl.) at screening
• Body Mass Index (BMI) of 18.5 to 29.9 kg/m2 (incl.) at screening
• Signed and dated written informed consent prior to admission to the study in accordance with International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation

Exclusion Criteria

• Any finding in the medical examination (including blood pressure, pulse rate or Electrocardiogram (ECG)) deviating from normal and judged as clinically relevant by the Investigator
• Repeated measurement of systolic blood pressure outside the range of 90 to 140 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
• Any evidence of a concomitant disease judged as clinically relevant by the Investigator
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Cholecystectomy and/or surgery of the gastrointestinal tract (except appendectomy and simple hernia repair) that could interfere with the PK of the trial medication
• Diseases of the Central Nervous System (CNS) (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
• History of relevant orthostatic hypotension, fainting spells, or blackouts
• Chronic or acute infections which are of relevance in the opinion of the Investigator
• History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)
• Use of drugs within 30 days prior to administration of trial medication if that might reasonably influence the results of the trial (incl. QT/QTc (corrected QT interval) interval prolongation)
• Participation in another trial where an investigational drug has been administered within 60 days prior to planned administration of trial medication, or current participation in another trial involving administration of investigational drug
• Tobacco usage (more than 10 cigarettes or 3 cigars or 3 pipes per day)
• Alcohol abuse (consumption of more than 30 g per day)
• Drug abuse or positive drug screening
• Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial
• Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial
• A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome)
• Subject is assessed as unsuitable for inclusion by the Investigator; for instance, is considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study
• Unwillingness to adhere to the rules of UV-light protection

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CTC North GmbH & Co. KG, Hamburg

Hamburg, , Germany

Countries

Germany

References

Ooi QX, Kristoffersson A, Korell J, Flack M, L Plan E, Weber B. Bounded integer model-based analysis of psoriasis area and severity index in patients with moderate-to-severe plaque psoriasis receiving BI 730357. CPT Pharmacometrics Syst Pharmacol. 2023 Jun;12(6):758-769. doi: 10.1002/psp4.12948. Epub 2023 May 1.

Reference Type: DERIVED

PMID: 36919398 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.mystudywindow.com

Related Info

Other Identifiers

2017-001653-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1407-0002

Identifier Type: -

Identifier Source: org_study_id