Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

This Study is Done in Healthy Japanese Volunteers. It Looks at How Different Doses of BI 705564 Are Taken up in the Body and How Well They Are Tolerated

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: NCT03747926
Recruitment Status : Withdrawn (Substance discontinued.)
First Posted : November 20, 2018
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:

The primary objective of this trial is to investigate the safety and tolerability of BI 705564 in healthy male subjects following oral administration of single rising doses.

A secondary objective is the exploration of the PK including dose proportionality of BI 705564 after single dosing.


Condition or disease Intervention/treatment Phase
Healthy Drug: BI 705564 Drug: Placebo Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses of BI 705564 in Healthy Male Subjects (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)
Estimated Study Start Date : April 5, 2019
Estimated Primary Completion Date : August 12, 2019
Estimated Study Completion Date : September 2, 2019

Arm Intervention/treatment
Experimental: BI 705564 Drug: BI 705564
single-rising oral dose

Placebo Comparator: Placebo Drug: Placebo
single-rising oral dose




Primary Outcome Measures :
  1. Number [N (%)] of subjects with drug-related Adverse Events (AEs) [ Time Frame: Up to day 7 ]

Secondary Outcome Measures :
  1. AUC0-∞ (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 ]
  2. Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: Up to 72 hours ]


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.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 50 Years   (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), Respiratory Rate (RR), body temperature), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
  • Age of 20 to 50 years (incl.) at screening
  • Body Mass Index (BMI) of 18.5 to 25.0 kg/m2 (incl.) at screening
  • Signed and dated written informed consent in accordance with International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
  • Male subject who agree to minimize the risk of female partners becoming pregnant by fulfilling any of the following criteria starting from at least 30 days before the first administration of trial medication and until 90 days after the trial completion:

    • Use of adequate contraception, e.g., any of the following methods plus condom:

      --- combined oral contraceptives, intrauterine device.

    • Vasectomised (vasectomy at least 1 year prior to enrolment)
    • Surgical sterilised (including hysterectomy) of the subject's female partner

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
  • Repeated measurement of systolic BP outside the range of 90 to 140 mmHg, diastolic BP outside the range of 50 to 90 mmHg, or pulse rate (PR) outside the range of 45 to 90 beats per minute (bpm) at screening
  • Any laboratory value outside the reference range that the investigator considers to be of clinical relevance at screening
  • 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, including but not limited to mood disorders and any history of suicidality
  • History of relevant orthostatic hypotension, fainting spells, or blackouts
  • Chronic or relevant acute infections including human immunodeficiency virus (HIV), viral hepatitis, syphilis and/or tuberculosis or evidence of tuberculosis infection as defined by positive QuantiFERON TB-Gold (or T-SPOT) test. (Subject with positive Hepatitis B core antibody will not allowed to participate in this study)
  • History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)
  • Use of drugs within 30 days or 5 half-lives, whichever is longer 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)
  • Drug abuse or positive drug screening
  • Blood donation of more than 200 mL within 30 days or 400 mL within 12 weeks 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 msecond) 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
  • Subjects who, in the investigator's judgement, are perceived as having an increased risk of bleeding, e.g., history of haemorrhagic disorders, clinical relevant petechial bleeding, occult blood in faeces, haematuria in repeated urine tests, trauma or surgery within the last month, planned surgery during trial participation, history of arteriovenous malformation or aneurysm, history of gastroduodenal ulcer disease or gastrointestinal haemorrhage, history of intracranial, intraocular, spinal, retroperitoneal, or atraumatic intraarticular bleeding, use of drugs that may interfere with haemostasis during trial conduct (e.g., acetylic salicylic acid or other non-steroidal anti-inflammatory drugs)
  • Repeated absolute B cell (CD19+) counts below 40/μL at screening
  • Repeated platelet counts below 100 cells/nL (10.0×104/μL) at screening
  • Serum potassium below normal range at screening
  • A history or current clinical signs of acute pancreatitis

Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03747926     History of Changes
Other Study ID Numbers: 1408-0005
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 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'.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No