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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03116906
Date of registration: 06/04/2017
Prospective Registration: Yes
Primary sponsor: Boehringer Ingelheim
Public title: Safety and Tolerability of BI 685509 in Healthy Subjects
Scientific title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 685509 in Healthy Male Subjects
Date of first enrolment: April 24, 2017
Target sample size: 60
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03116906
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).  
Phase:  Phase 1
Countries of recruitment
Germany
Contacts
Name:     Boehringer Ingelheim
Address: 
Telephone:
Email:
Affiliation:  Boehringer Ingelheim
Key inclusion & exclusion criteria

Inclusion Criteria:

- Healthy male subjects according to the investigator's assessment, based on a complete
medical history including a physical examination, vital signs (BP (Blood Pressure), PR
(Pulse Rate)), 12-lead ECG (Electrocardiogram), and clinical laboratory tests

- Age of 18 to 50 years (incl.)

- Body Mass Index of 18.5 to 29.9 kg/m2 (incl.)

- Signed and dated written informed consent prior to admission to the study in
accordance with GCP (Good Clinical Practice) and local legislation

Exclusion Criteria:

- Any finding in the medical examination (including BP (Blood Pressure), PR (Pulse
Rate), or ECG (Electrocardiogram)) is deviating from normal and judged as clinically
relevant by the investigator

- Repeated measurement of systolic blood pressure outside the range of 100 to 140 mmHg,
diastolic blood pressure outside the range of 60 to 90 mmHg, or pulse rate outside the
range of 45 to 90 bpm (beats per minute)

- 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 during in-house confinement

- Alcohol abuse (consumption of more than 24 g per day for males)

- 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

- Inability to comply with dietary regimen of trial site

- A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are
repeatedly greater than 450 ms) or any other relevant ECG finding at screening

- 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,
because considered not able to understand and comply with study requirements, or has a
condition that would not allow safe participation in the study



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Male
Health Condition(s) or Problem(s) studied
Healthy
Intervention(s)
Drug: Placebo
Drug: BI 685509
Primary Outcome(s)
Percentage of subjects with drug-related Adverse Events [Time Frame: 5 weeks]
Secondary Outcome(s)
AUC tau,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval tau) [AUC tau,ss will be AUC0-12,ss for bid and AUC0-24,ss for QD] [Time Frame: up to 408 hours]
AUC tau,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval tau after administration of the first dose) [AUC tau,1 will be AUC0-24 for QD] [Time Frame: up to 24 hours]
Cmax (maximum measured concentration of the analyte in plasma) [Time Frame: up to 72 hours]
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval tau) [Time Frame: up to 408 hours]
Secondary ID(s)
2014-004540-35
1366.3
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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