Safety and Tolerability of BI 685509 in Healthy Subjects

NCT03116906 | Completed Phase 1

• 2 other identifiers: 1366.32014-004540-35
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this trial is to investigate the safety and tolerability of BI 685509 in healthy male subjects following oral administration of multiple rising doses. Secondary objectives are the exploration of the pharmacokinetics (PK), dose proportionality, the attainment of steady state, as well as investigation of linearity and pharmacodynamics (PD) of BI 685509 after multiple dosing.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects with drug-related Adverse Events

  5 weeks

Secondary Outcomes (4)

• 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]

  up to 24 hours

• Cmax (maximum measured concentration of the analyte in plasma)

  up to 72 hours

• 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]

  up to 408 hours

• Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval tau)

  up to 408 hours

Study Arms (2)

BI 685509

EXPERIMENTAL

multiple rising doses of BI 685509

Drug: BI 685509

Placebo

PLACEBO COMPARATOR

matching placebo

Drug: Placebo

Interventions

BI 685509 DRUG

to be given for a total of up to 15 days

BI 685509

Placebo DRUG

to be given for a total of up to 15 days

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

CRS Clinical Research Services Mannheim GmbH

Mannheim, 68167, Germany

Location

Related Publications (1)

• Wong D, Seitz F, Bauer V, Giessmann T, Schulze F. Safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 685509, a soluble guanylyl cyclase activator, in healthy volunteers: Results from two randomized controlled trials. Naunyn Schmiedebergs Arch Pharmacol. 2024 Oct;397(10):8101-8116. doi: 10.1007/s00210-024-03165-w. Epub 2024 May 24.

  PMID: 38789635 DERIVED

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

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 6, 2017
• First Posted: April 17, 2017
• Study Start: April 24, 2017
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: June 11, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)