Safety and Pharmacokinetics of Single Rising Doses of BI 705564 and Food Effect on BI 705564 in Healthy Male Subjects
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 705564 (Single-blind, Partially Randomised, Placebo-controlled Parallel Group Design) and Food Effect on a Tablet Formulation of BI 705564 (Open-label, Randomised, Single-dose, Two-period, Two-sequence Crossover Design) in Healthy Male Subjects
2 other identifiers
interventional
91
1 country
1
Brief Summary
Investigation of safety, tolerability, pharmacokinetics and pharmacodynamics of single rising doses of BI 705564 and of the food effect on BI 705564 in healthy male subjects
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Apr 2017
Longer than P75 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2017
CompletedFirst Posted
Study publicly available on registry
April 21, 2017
CompletedStudy Start
First participant enrolled
April 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 19, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 19, 2018
CompletedResults Posted
Study results publicly available
July 6, 2022
CompletedJuly 6, 2022
March 1, 2022
10 months
April 13, 2017
March 16, 2022
March 16, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
Number of Participants With Drug-related Adverse Events (AEs)
Number of participants with drug-related adverse events (AEs) is presented for SRD part.Percentage of participants with treatment-emergent drug-related Adverse Events (AEs) is reported. Percentages are calculated using total number of subjects per treatment as the denominator.
From drug administration until end of the treatment, up to 15 days (for SRD fasting and fed conditions).
Area Under the Concentration-time Curve of BI 705564 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) (FE Part)
AUC0-tz, area under the concentration-time curve of BI 705564 in plasma over the time interval from 0 to the last quantifiable data point for FE part is presented.
Pharmacokinetic samples were collected pre-dose and at 0:30 (hour: minute), 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 after drug administration.
Maximum Measured Concentration of BI 705564 in Plasma (Cmax) (FE Part)
Cmax, maximum measured concentration of BI 705564 in plasma is presented for FE part.
Pharmacokinetic samples were collected pre-dose and at 0:30 (hour: minute), 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 after drug administration.
Secondary Outcomes (3)
Maximum Measured Concentration of BI 705564 in Plasma (Cmax) (SRD Part)
Pharmacokinetic samples were collected pre-dose and at 0:30 (hour: minute), 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 after drug administration.
Area Under the Concentration-time Curve of BI 705564 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) (SRD Part)
Pharmacokinetic samples were collected pre-dose and at 0:30 (hour: minute), 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 after drug administration.
Area Under the Concentration-time Curve of BI 705564 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) (FE Part)
Pharmacokinetic samples were collected pre-dose and at 0:30 (hour: minute), 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 after drug administration.
Study Arms (14)
Placebo matching BI 705564 fasted (SRD part)
EXPERIMENTALPlacebo matching BI 705564 fed (SRD part)
EXPERIMENTAL1 milligram (mg) BI 705564 fasted (SRD part)
EXPERIMENTAL3 mg BI 705564 fasted (SRD part)
EXPERIMENTAL10 mg BI 705564 fasted (SRD part)
EXPERIMENTAL20 mg BI 705564 fasted (SRD part)
EXPERIMENTAL40 mg BI 705564 fasted (SRD part)
EXPERIMENTAL80 mg BI 705564 fasted (SRD part)
EXPERIMENTAL20 mg BI 705564 fed (SRD part)
EXPERIMENTAL40 mg BI 705564 fed (SRD part)
EXPERIMENTAL80 mg BI 705564 fed (SRD part)
EXPERIMENTAL160 mg BI 705564 fed (SRD part)
EXPERIMENTALBI 705564 10 mg fasted/ BI 705564 10 mg fed (FE Part)
EXPERIMENTALBI 705564 10 mg fed/ BI 705564 10 mg fasted (FE Part)
EXPERIMENTALInterventions
Tablet and solution formulation
Fed state
Fasting state
Eligibility Criteria
You may qualify if:
- Healthy male subjects according to the assessment of the investigator, 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 (incl.)
- Body Mass 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
You may not qualify if:
- \-- 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 140mmHg, 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 seizures 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)
- 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 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
- Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
- Inability to refrain from smoking on specified trial days
- Alcohol abuse (consumption of more than 30 g per day)
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Humanpharmakologisches Zentrum Biberach
Biberach, 88397, Germany
Related Links
Results Point of Contact
- Title
- Boehringer Ingelheim, Call Center
- Organization
- Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2017
First Posted
April 21, 2017
Study Start
April 27, 2017
Primary Completion
February 19, 2018
Study Completion
February 19, 2018
Last Updated
July 6, 2022
Results First Posted
July 6, 2022
Record last verified: 2022-03