NCT02694354

Brief Summary

To investigate safety, tolerability, pharmacokinetics and pharmacodynamics following single rising oral doses of BI 685509

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Mar 2016

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 29, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

May 4, 2016

Status Verified

May 1, 2016

Enrollment Period

1 month

First QC Date

February 25, 2016

Last Update Submit

May 3, 2016

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Number [N(%)] of the subject with drug-related Adverse Events

    0-48 hours

Secondary Outcomes (2)

  • AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

    0-24 hours

  • Cmax (maximum concentration of the analyte in plasma)

    0-24 hours

Study Arms (2)

BI 685509

EXPERIMENTAL
Drug: BI 685509

Placebo

PLACEBO COMPARATOR

matching placebo

Drug: Placebo

Interventions

BI 685509DRUG
BI 685509
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
  • Age of 18 to 50 years (incl.)
  • 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 and local legislation

You may not qualify if:

  • Any finding in the medical examination (including BP, PR or ECG) 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 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)
  • Intake of drugs with a long half-life (more than 24 h) within 30 days or less than 10 half-lives of the respective drug prior to administration of trial medication
  • Within 10 days prior to administration of trial medication, use of drugs that might reasonably influence the results of the trial or that might prolong the QT/corrected QT interval
  • Participation in another trial where an investigational drug has been administered within 60 days prior to planned administration of trial medication
  • Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
  • Inability to refrain from smoking on specified trial days
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1366.1.1 Boehringer Ingelheim Investigational Site

Biberach, 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: 38789635DERIVED

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2016

First Posted

February 29, 2016

Study Start

March 1, 2016

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

May 4, 2016

Record last verified: 2016-05

Locations

DE(1)