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A Study in Healthy Men and Women to Find Out How Well Different Doses of BI 1291583 Are Tolerated

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ClinicalTrials.gov Identifier: NCT03868540
Recruitment Status : Recruiting
First Posted : March 11, 2019
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 1291583 in healthy male and female subjects following oral administration of multiple rising doses over 4 weeks.

Condition or disease Intervention/treatment Phase
Healthy Drug: BI 1291583 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Rising Oral Doses of BI 1291583 qd Versus Placebo in Healthy Male and Female Subjects for 4 Weeks (Single-blind, Partially Randomised, Placebo-controlled Parallel Group Design)
Actual Study Start Date : March 28, 2019
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : April 1, 2020

Arm Intervention/treatment
Experimental: BI 1291583 Drug: BI 1291583
tablet

Placebo Comparator: Placebo Drug: Placebo
tablet




Primary Outcome Measures :
  1. Percentage of subjects with drug-related adverse events [ Time Frame: Up to Day 86 ]

Secondary Outcome Measures :
  1. AUCτ,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ after administration of the first dose) [ Time Frame: Up to 24 hours ]
  2. Cmax,1 (maximum measured concentration of the analyte in plasma after administration of the first dose) [ Time Frame: Up to 24 hours ]
  3. AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ) [ Time Frame: Up to 672 hours ]
  4. Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) [ Time Frame: Up to 672 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (Blood pressure (BP), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
  • Age of 18 to 45 years (inclusive)
  • Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
  • Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation
  • Male, or female (of non-childbearing potential) subjects -- For 'female of non-childbearing potential' at least one of the following criteria must be fulfilled:

    • Permanently sterile (permanent sterilisation methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy)
    • Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with FSH above 40 U/L and estradiol below 30 ng/L is confirmatory)

Exclusion Criteria:

  • Any finding in the medical examination (including Blood pressure (BP), Pulse rate (PR), or Electrocardiogram (ECG)) deviating from normal and assessed as clinically relevant by the investigator
  • Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 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 assessed as clinically relevant by the investigator
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders
  • Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or 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 of planned administration of trial medication that might reasonably influence the results of the trial (including drugs that cause QT/QTc interval prolongation)
  • Intake of an investigational drug in another clinical trial within 60 days of planned administration of investigational drug in the current trial, or concurrent participation in another clinical trial in which investigational drug is administered
  • 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 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 of planned administration of trial medication or intended blood donation during the trial
  • Intention to perform excessive physical activities within one week prior to the administration of trial medication or during the trial
  • Inability to comply with the dietary regimen of the 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 Torsade de Pointes (such as heart failure, hypokalaemia, or family history of Long QT Syndrome)
  • Subject is assessed as unsuitable for inclusion by the investigator, for instance, because the subject is not considered able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study
  • Male subjects with 'women of childbearing potential' (WOCBP) partner who are unwilling to use male contraception (condom or sexual abstinence) from the first administration of trial medication until 30 days after the last administration of trial medication
  • Known relevant immunodeficiency
  • History and/or presence of tuberculosis; positive result for interferon gamma release assay (IGRA) (i.e., QuantiFERON TB-Gold)
  • Positive results for Hepatitis B antigen, Hepatitis C antibodies and/or human immunodeficiency virus (HIV) 1 antigen or HIV1/2 antibodies, at screening
  • Aural body temperature of more than 37.7°C on Day -3 to -1
  • Volunteers who have received live or live-attenuated vaccine in the 4 weeks prior to dosing
  • C-reactive protein above upper limit of laboratory reference range at screening and/or on Day -3 to -1
  • Subjects with signs of current gingivitis/periodontitis. Inspection of the oral cavity will be performed by the investigator
  • Subjects with a history of hyperkeratosis or erythema in palms or soles

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): NCT03868540


Contacts
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Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
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Germany
CRS Clinical Research Services Mannheim GmbH Recruiting
Mannheim, Germany, 68167
Contact: Friedeborg Seitz    +49 (621) 15045152    friedeborg.seitz@crs-group.de   
Sponsors and Collaborators
Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03868540     History of Changes
Other Study ID Numbers: 1397-0002
2018-001245-14 ( EudraCT Number )
First Posted: March 11, 2019    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). Requestors can use the following link http:// trials.boehringer-ingelheim.com/ to:

  1. find information in order to request access to clinical study data, for listed studies.
  2. request access to clinical study documents that meet criteria, and upon a signed 'Document Sharing Agreement'.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No