Multiple Rising Oral Doses of BI 691751 in Healthy Male Subjects

NCT02148107 | Terminated Phase 1 Results

• 2 other identifiers: 1334.22013-003813-17
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

It is the objective of this MRD trial to investigate pharmacokinetics, pharmcodynamics, safety and tolerability of rising doses BI 691751 over a treatment period of 14 days to support the further clinical development of this LTA4H-inhibitor. Special emphasis will be given to detect potential effects of BI 691751 on heart rate.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects With Drug-related Adverse Events

  Percentage of subjects with drug-related Adverse events (AEs)

  From the time of administration of the respective treatment until 21 days after last administration of study drug or start of the post-study phase to the respective treatment, up to 35 days

Secondary Outcomes (4)

• AUCt,1 (Area Under the Concentration-time Curve of the Analyte in Plasma Over a Uniform Dosing Interval t After Administration of the First Dose)

  0 minutes (min), 10min, 20min, 40min, 1 hour (h), 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h and 24h after first drug administration

• Cmax (Maximum Measured Concentration of the Analyte Inplasma)

  0 minutes (min), 10min, 20min, 40min, 1 hour (h), 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h and 24h after first drug administration

• AUCt,ss (Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t)

  312 hours (h), 312 h 10 minutes (min), 312h 20min, 312h 40min, 313, 313h 30min, 314h, 315h, 316h, 318h, 320h, 322h, 324h and 336h after first drug administration

• Cmax,ss (Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t)

  312 hours (h), 312 h 10 minutes (min), 312h 20min, 312h 40min, 313, 313h 30min, 314h, 315h, 316h, 318h, 320h, 322h, 324h and 336h after first drug administration

Study Arms (7)

BI 691751 Dose 1

EXPERIMENTAL

multiple dose given over 14 days

Drug: BI 691751

BI 691751 Dose 2

EXPERIMENTAL

multiple dose given over 14 days

Drug: BI 691751

BI 691751 Dose 3

EXPERIMENTAL

multiple dose given over 14 days

Drug: BI 691751

BI 691751 Dose 4

EXPERIMENTAL

multiple dose given over 14 days

Drug: BI 691751

BI 691751 Dose 5

EXPERIMENTAL

multiple dose given over 14 days

Drug: BI 691751

BI 691751 Dose 6

EXPERIMENTAL

multiple dose given over 14 days

Drug: BI 691751

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

BI 691751 DRUG

BI 691751 Dose 1

BI 691751 Dose 1

Placebo DRUG

Placebo

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 (electro cardiogramm), and clinical laboratory tests
• Age of 18 to 50 years (incl.)
• BMI (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
• Subject is able to understand and communicate in German

You may not qualify if:

• Any finding in the medical examination (including BP (blood pressure), PR (pulse rate) or ECG (electro cardiogramm) is deviating from normal and judged as clinically relevant by the investigator
• Pulse rate outside 45-80 bpm (beats per minutes) or repeated measurement of systolic blood pressure greater than 140 mmHg, diastolic blood pressure greater than 90 mm Hg
• 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
• Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication
• Diseases of the central nervous system (such as epilepsy), other neurological disorders 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/QTc 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 during inhouse-confinement

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1334.2.1 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

Limitations and Caveats

The trial was terminated prematurely because the sponsor decided to discontinue the development of BI 691751, also no PK blood samples were analysed because of the trial termination.

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: May 19, 2014
• First Posted: May 28, 2014
• Study Start: May 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: August 1, 2014
• Last Updated: February 29, 2016
• Results First Posted: February 29, 2016

Record last verified: 2016-02

Locations

DE (1)