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This Study Tests How Healthy Men Tolerate Different Doses of BI 730357 and How the Metabolism of Midazolam is Affected by BI 730357

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ClinicalTrials.gov Identifier: NCT03279978
Recruitment Status : Recruiting
First Posted : September 12, 2017
Last Update Posted : June 13, 2018
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Phase Ib evaluation of the safety, tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) properties of Multiple Rising Dose (MRD) administration of BI 730357 to healthy volunteers for up to 28 days.

Condition or disease Intervention/treatment Phase
Healthy Psoriasis Drug: BI 730357 Drug: Placebo Drug: Midazolam Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase Ib Evaluation of the Safety and Tolerability and Effect on Midazolam Metabolism of the Administration of Multiple Rising Doses of BI 730357 to Healthy Volunteers
Actual Study Start Date : January 9, 2018
Estimated Primary Completion Date : August 20, 2018
Estimated Study Completion Date : August 27, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BI 730357 Drug: BI 730357
up to 28 days

Drug: Midazolam
Dose groups 4 & 5 only

Placebo Comparator: Placebo Drug: Placebo
up to 28 days

Drug: Midazolam
Dose groups 4 & 5 only




Primary Outcome Measures :
  1. Number of subjects with drug-related Adverse Events (AEs) [ Time Frame: up to 5 weeks ]

Secondary Outcome Measures :
  1. AUCtau,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval tau after administration of the first dose) [ Time Frame: Week 4 ]
  2. After the first dose: Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: Week 4 ]
  3. After the last dose: AUCtau,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval tau) [ Time Frame: Week 4 ]
  4. After the last dose:Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval tau) [ Time Frame: Week 4 ]


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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 male subjects according to the assessment of the Investigator, based on a complete medical history, physical examination, vital signs (blood pressure, pulse rate), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
  • Subjects with a partner who is a woman of childbearing potential (WOCBP) must be willing to use male contraception (condom or sexual abstinence) from the first administration of trial medication until 30 days after last administration of trial medication
  • Age of 18 to 45 years (incl.) at screening
  • Body Mass Index (BMI) of 18.5 to 29.9 kg/m2 (incl.) at screening
  • Signed and dated written informed consent prior to admission to the study in accordance with International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation

Exclusion criteria

  • Any finding in the medical examination (including blood pressure, pulse rate or Electrocardiogram (ECG)) deviating from normal and judged 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 beats per minute (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 (except appendectomy and simple hernia repair) that could interfere with the PK of the trial medication
  • Diseases of the Central Nervous System (CNS) (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 acute infections which are of relevance in the opinion of the Investigator
  • 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 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
  • Tobacco usage (more than 10 cigarettes or 3 cigars or 3 pipes per day)
  • Alcohol abuse (consumption of more than 30 g per day)
  • 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
  • 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, is considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study
  • Unwillingness to adhere to the rules of UV-light protection

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): NCT03279978


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

Locations
Germany
CTC North GmbH & Co. KG, Hamburg Recruiting
Hamburg, Germany, 20251
Contact: Alen Jambrecina    +49 (40) 524719400    a.jambrecina@ctc-north.com   
Sponsors and Collaborators
Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03279978     History of Changes
Other Study ID Numbers: 1407-0002
2017-001653-14 ( EudraCT Number )
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: June 2018

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

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Midazolam
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action