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Influence of Fluvoxamine on the Pharmacokinetics of BI 409306

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ClinicalTrials.gov Identifier: NCT02853136
Recruitment Status : Completed
First Posted : August 2, 2016
Last Update Posted : June 15, 2017
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
To investigate the influence of fluvoxamine on the pharmacokinetics of BI 409306

Condition or disease Intervention/treatment Phase
Healthy Drug: Fluvoxamine Drug: BI 409306 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Influence of Fluvoxamine on the Pharmacokinetics of BI 409306 After Oral Administration (Randomized, Open-label, Two-treatment, Two-sequence, Two-period Crossover Study)
Actual Study Start Date : August 25, 2016
Actual Primary Completion Date : October 17, 2016
Actual Study Completion Date : October 25, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Reference Treatment (pilot phase)
BI 409306 low dose
Drug: BI 409306
low single dose

Experimental: Test Treatment (pilot phase)
Fluvoxamin and low dose of BI 409306
Drug: Fluvoxamine
single dose

Drug: BI 409306
low single dose

Experimental: Reference Treatment (main phase)
BI 409306 medium or high dose
Drug: BI 409306
medium or high dose

Experimental: Test Treatment (main phase)
Fluvoxamin and medium or high dose of BI 40930
Drug: Fluvoxamine
single dose

Drug: BI 409306
medium or high dose




Primary Outcome Measures :
  1. Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point [ Time Frame: up to 72 hours ]
  2. Maximum measured concentration of the analyte in plasma [ Time Frame: up to 72 hours ]

Secondary Outcome Measures :
  1. Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity [ Time Frame: up to 72 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Healthy male or female subjects 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 GCP and local legislation
  • Male or female subjects who meet any of the following criteria starting from screening until 30 days after trial completion regarding adequate contraception:

    • Non-hormonal intra-uterine device in combination with condom
    • Sexually abstinent
    • Surgically sterilised (including hysterectomy)
    • A vasectomised sexual partner (vasectomy at least 1 year prior to enrolment)
    • Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of FSH above 40 U/L and estradiol below 30 ng/L is confirmatory)

Exclusion criteria:

  • 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 85 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 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
  • Current smoker or ex-smoker who quit smoking less than 30 days prior to screening
  • Alcohol abuse (consumption of more than 20 g per day for females and 30 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 in males or repeatedly greater than 470 ms in females) 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
  • History of major bleeding events (e.g. gastric bleeding, intracranial haemorrhage) based on the investigator's judgement
  • Intake of drugs that may interfere with fluvoxamine such as monoamine oxidase inhibitors, and tizanidine.
  • Intake of hormonal contraception or ovary hormone replacement therapy in female subjects
  • Subjects with a medical history of suicidal behaviour
  • History of increased intraocular pressure
  • Positive pregnancy test, pregnancy or plans to become pregnant within 30 days after study completion
  • Lactation period

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02853136


Locations
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Germany
1289.35.1 Boehringer Ingelheim Investigational Site
Biberach, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02853136    
Other Study ID Numbers: 1289.35
2016-000752-10 ( EudraCT Number: EudraCT )
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: June 15, 2017
Last Verified: June 2017
Additional relevant MeSH terms:
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Fluvoxamine
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors