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This Study in Healthy Men Tests How the Body Takes up BI 1467335

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03483506
Recruitment Status : Completed
First Posted : March 30, 2018
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:

The primary objective of this trial is to investigate the absolute bioavailability of BI 1467335 with an intravenous microdose formulation containing labelled [C-14] BI 1467335 and an unlabelled oral tablet formulation of BI 1467335 in healthy male subjects.

The secondary objective is the evaluation of additional pharmacokinetic parameters following the two treatments.


Condition or disease Intervention/treatment Phase
Healthy Drug: BI 1467335 Drug: BI 1467335 (C-14) intravenous solution Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open-label, Single-arm Multiple Dose Trial to Investigate Pharmacokinetics and Absolute Bioavailability of BI 1467335 Administered as an Oral Dose Simultaneously With an Intravenous Microtracer Dose of [C-14] BI 1467335 After Single and Multiple Oral Doses in Healthy Male Volunteers
Actual Study Start Date : April 10, 2018
Actual Primary Completion Date : June 5, 2018
Actual Study Completion Date : June 5, 2018

Arm Intervention/treatment
Experimental: All subjects Drug: BI 1467335
Film-coated tablet

Drug: BI 1467335 (C-14) intravenous solution
Intravenous solution




Primary Outcome Measures :
  1. Cmax (maximum measured concentration of the analyte after oral administration) [ Time Frame: Day 1 ]
  2. AUC0-inf (area under the concentration-time curve of the analyte over the time interval from 0 to infinity after oral administration) [ Time Frame: Day 1 ]
  3. Cmax (maximum measured concentration of the analyte after intravenous administration) [ Time Frame: Day 1 ]
  4. AUC0-inf (area under the concentration-time curve of the analyte over the time interval from 0 to infinity after intravenous administration) [ Time Frame: Day 1 ]
  5. Cmax, 28 (maximum measured concentration of the analyte after oral administration on Day 28) [ Time Frame: Day 28 ]
  6. AUC 0-24, 28 (area under the concentration-time curve of the analyte over the time interval from 0 to 24 h after oral administration on Day 28) [ Time Frame: Day 28 ]
  7. Cmax, 28 (maximum measured concentration of the analyte from 0 to infinity after intravenous administration on Day 28) [ Time Frame: Day 28 ]
  8. AUC 0-∞, 28 (area under the concentration-time curve of the analyte from 0 to infinity after intravenous administration on Day 28) [ Time Frame: Day 28 ]

Secondary Outcome Measures :
  1. tmax, tmax,28 (time from dosing to the maximum measured concentration of the analyte) [ Time Frame: Day 1 and Day 28 ]
  2. t1/2, (observed terminal half-life of the analyte) for the oral dose on Day 1 [ Time Frame: Day 1 ]
  3. t1/2, t1/2,28 following the iv dose [ Time Frame: Day 1 and Day 28 ]
  4. CL, CL28 (clearance of the analyte) [ Time Frame: Day 1 and Day 28 ]
  5. Vz, Vz,28 (volume of distribution of the analyte on Day 1 and on Day 28) [ Time Frame: Day 1 and Day 28 ]
  6. F (absolute bioavailability) at day 1 and at day 28 [ Time Frame: Day 1 and Day 28 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male subjects according to the investigator's assessment, 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 65 years (incl.)
  • Body mass index (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 (GCP) and local legislation
  • Subjects who are sexually active must use, with their partner, highly effective contraception from the time of administration of trial medication until 4 months after administration of trial medication. Adequate methods are:

    • Condoms plus use of hormonal contraception by the female partner that started at least 2 months prior to administration of trial medication (e.g., implants, injectables, combined oral or vaginal contraceptives, intrauterine device) or
    • Condoms plus surgical sterilization (vasectomy at least 1 year prior to enrolment) or
    • Condoms plus surgically sterilised partner (including hysterectomy) or
    • Condoms plus intrauterine device or
    • Condoms plus partner of non-childbearing potential (including homosexual men) study drug via seminal fluid.

Alternatively, true abstinence is acceptable when it is in line with the subject's preferred and usual lifestyle. If a subject is usually not sexually active but becomes active, with their partner, they must comply with the contraceptive requirements detailed above.

Exclusion Criteria:

  • 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
  • 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
  • Clinically significant gastrointestinal, hepatic, renal, respiratory (including but not limited to interstitial lung disease), 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)
  • Within 30 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, or current participation in another trial involving administration of investigational drug
  • Smoker (more than 5 cigarettes or 1 cigar or 1 pipe per day)
  • Inability to refrain from smoking on specified trial days
  • Average intake of more than 24 units of alcohol per week (1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits)e the reference range that the investigator considers to be of clinical relevance
  • 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
  • Inability to comply with dietary regimen of trial site
  • A marked baseline prolongation of QT/QTc interval (such as QTcF intervals that are repeatedly greater than 450 ms) 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

In addition, the following trial-specific exclusion criteria apply:

- Exposure to radiation for diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton (excluding spinal column) in the period of 1 year prior to screening


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): NCT03483506


Locations
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Netherlands
PRA Health Sciences Onderzoekscentrum Martini
Groningen, Netherlands, 9728 NZ
Sponsors and Collaborators
Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03483506    
Other Study ID Numbers: 1386-0019
2017-003853-41 ( EudraCT Number )
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pharmaceutical Solutions