Single Rising Dose Study of BI 690517 in Healthy Volunteers

NCT02891148 | Completed Phase 1

• 2 other identifiers: 1378.12015-003642-10
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate safety, tolerability, pharmacokinetics and pharmacodynamics following single rising doses of BI 690517

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• The percentage of subjects with adverse reactions, analysed as investigator defined drug-related adverse events.

  The percentage of subjects with adverse reactions, analysed as investigator defined drug-related adverse events (AEs).

  From the first drug administration until end of the trial, up to 14 days

Secondary Outcomes (2)

• Area under the concentration-time curve of the BI-690517 in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity)

  Pharmacokinetic blood samples: 1:30 hours before drug administration and 30 minutes, 1, 1:30, 2, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 hours after drug administration.

• Maximum measured concentration of the BI-690517 in plasma (Cmax)

  PK blood samples: 1:30 hours before drug administration and 30 minutes, 1, 1:30, 2, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 hours after drug administration.

Study Arms (1)

BI 690517

EXPERIMENTAL

Drug: BI 690517

Interventions

BI 690517 DRUG

Also known as: Vicadrostat

BI 690517

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 (blood pressure, pulse rate), 12-lead electrocardiogram, 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 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 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)
• 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 for males)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Humanpharmakologisches Zentrum Biberach

Biberach, 88397, Germany

Location

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2016
• First Posted: September 7, 2016
• Study Start: September 29, 2016
• Primary Completion: December 12, 2016
• Study Completion: December 12, 2016
• Last Updated: September 20, 2024

Record last verified: 2024-09

Locations

DE (1)