Clinical Trials/NCT03325712

NCT03325712

Completed

Phase 1

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 705564 (Double-blind, Randomised, Placebo-controlled, Parallel-group Design) and Evaluation of Midazolam Interaction (Nested, Open, Fixed-sequence, Intra-individual Comparison) in Healthy Male Subjects

Boehringer Ingelheim1 site in 1 country60 target enrollmentNovember 17, 2017

ConditionsHealthy

InterventionsBI 705564 Midazolam Placebo

DrugsBI 705564 Placebo Midazolam

Overview

Phase: Phase 1
Intervention: BI 705564
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Enrollment: 60
Locations: 1
Primary Endpoint: Percentage of Participants With Drug-related Adverse Events
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of this trial is to investigate safety and tolerability of BI 705564 in healthy male subjects, following oral administration of multiple rising doses.

Secondary objectives are the exploration of the pharmacokinetics, including dose proportionality and investigation of linearity.

Registry

clinicaltrials.gov

Start Date

November 17, 2017

End Date

November 26, 2018

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Boehringer Ingelheim

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Dose Groups (DGs)1 to 5: Healthy male subjects according to the assessment of the investigator, based on a complete medical history, a physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests;
•DG 8, only: Otherwise healthy male subjects (as defined for DGs 1 to 5) with a history (of at least 1 year) of IgE-mediated, perennial allergies, predominantly to (house) dust mite (dermatophagoides pteronyssinus or dermatophagoides farina) as documented by a positive Skin prick test (SPT)(largest diameter of wheal at screening \> 5 mm)
•Age of 18 to 50 years (incl.)
•Body Max Index (BMI) of 18.5 to 29.9 kg/m2 (incl.)
•Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation

Exclusion Criteria

•Any finding in the medical examination (including Blood Pressure (BP), Pulse Rate (PR) or Electrocardiogram (ECG)) is 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 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 that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)
•Diseases of the central nervous system (including but not limited to any kind of seizure or stroke), and other relevant neurological or psychiatric disorders
•History of relevant orthostatic hypotension, fainting spells, or blackouts
•Chronic or relevant acute infections
•History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)

Arms & Interventions

Dose group 4: BI 705564 80 mg

Intervention: BI 705564

Dose group 4: BI 705564 80 mg

Intervention: Midazolam

Dose group 1: BI 705564 10 mg

Intervention: BI 705564

Dose group 2: BI 705564 20 mg

Intervention: BI 705564

Dose group 2: BI 705564 20 mg

Intervention: Midazolam

Dose group 3: BI 705564 40 mg

Intervention: BI 705564

Dose group 3: BI 705564 40 mg

Intervention: Midazolam

Dose group 5: BI 705564 60 mg

Intervention: BI 705564

Dose group 5: BI 705564 60 mg

Intervention: Midazolam

Placebo matching BI 705564

Intervention: Placebo

Placebo matching BI 705564

Intervention: Midazolam

Dose group 8: BI 705564 40 mg - SPT

SPT stands for skin prick test.

Intervention: BI 705564

Placebo matching BI 705564 - SPT

SPT stands for skin prick test.

Intervention: Placebo

Outcomes

Primary Outcomes

Percentage of Participants With Drug-related Adverse Events

Time Frame: From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564") or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").

Percentage of participants with drug-related adverse events is reported.

Secondary Outcomes

Maximum Measured Concentration of BI 705564 in Plasma (Cmax) After the Administration of the First Dose(1 hour(s) (h) prior drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h after first BI 705564 dose (for dose groups 1 to 5); 1.5 h prior drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 23 h after first BI 705564 dose (for dose group 8).)
Maximum Measured Concentration of BI 705564 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss) After the Administration of the Last Dose(1 h before last dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h after last BI 705564 dose on Day 17 (for dose groups 1 to 5); 1.5 h before last dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 23 h after last BI 705564 dose on Day 28 (for dose group 8).)
Area Under the Concentration-time Curve of BI 705564 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss) After the Administration of the Last Dose(1 h before last dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h after last BI 705564 dose on Day 17 (for dose groups 1 to 5); 1.5 h before last dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 23 h after last BI 705564 dose on Day 28 (for dose group 8).)
Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) After the First and Last Dose(1.5 h prior midazolam administration and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6 and 8 h after first midazolam dose on Day -1 and 1h prior midazolam administration and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6 and 8 h after last midazolam dose on Day 17.)
Area Under the Concentration-time Curve of BI 705564 in Plasma Over a Uniform Dosing Interval τ After Administration of the First Dose (AUCτ,1)(1 hour(s) (h) prior drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h after first BI 705564 dose (for dose groups 1 to 5); 1.5 h prior drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 23 h after first BI 705564 dose (for dose group 8).)
Maximum Measured Concentration of Midazolam in Plasma (Cmax) After the First and Last Dose(1.5 h prior midazolam administration and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6 and 8 h after first midazolam dose on Day -1 and 1h prior midazolam administration and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6 and 8 h after last midazolam dose on Day 17.)