This Study is Done in Healthy Japanese Volunteers. It Looks at How Different Doses of BI 730357 Are Taken up in the Body and How Well They Are Tolerated

• ClinicalTrials.gov Identifier: NCT03793621
• Recruitment Status: Completed
• First Posted: January 4, 2019
• Last Update Posted: May 14, 2019
• Sponsor: Boehringer Ingelheim
• Information provided by (Responsible Party): Boehringer Ingelheim

Study Description

Brief Summary:

The main objective of this trial is to investigate the safety and tolerability of BI 730357 in Japanese healthy male subjects following oral administration of single rising doses.

Secondary objectives are the explorations of the pharmacokinetic(s) (PK), including dose proportionality as well as investigation of linearity of BI 730357 after single dose administration.

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses of BI 730357 in Japanese Healthy Male Subjects (Double-blind, Randomised, Placebo-controlled, Parallel Group Design)
• Actual Study Start Date: January 21, 2019
• Actual Primary Completion Date: April 26, 2019
• Actual Study Completion Date: April 26, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: BI 730357	Drug: BI 730357; single rising oral dose
Placebo Comparator: Placebo	Drug: Placebo; single rising oral dose

Outcome Measures

Primary Outcome Measures :

1. [N (%)] of subjects with drug-related adverse events [ Time Frame: Up to 168 hours ]

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 168 hours ]
2. Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: Up to 168 hours ]

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 45 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

• Japanese ethnicity, according to the following criteria:

  -- born in Japan, have lived outside of Japan <10 years, and have parents and grandparents who are Japanese

• Age of 20 to 45 years (inclusive) at screening
• Body Mass Index (BMI) of 18.5 to 25.0 kg/m2 (inclusive) at screening
• Signed and dated written informed consent in accordance with International Council for 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 participation to this trial 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 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 (CNS) (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
• 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 (including potential for 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
• Previous exposure to BI 730357
• 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 for males)
• Drug abuse or positive drug screening
• Whole blood donation of more than 200 mL within 30 days or 400 mL within 12 weeks, or plasmapheresis and platelet apheresis within 2 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 mseconds) 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

Contacts and Locations

Locations

Japan

SOUSEIKAI Sumida Hospital

Tokyo, Sumida-ku, Japan, 130-0004

Sponsors and Collaborators

Boehringer Ingelheim

More Information

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT03793621
• Other Study ID Numbers: 1407-0015
• First Posted: January 4, 2019
• Last Update Posted: May 14, 2019
• Last Verified: May 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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). For more details refer to: http://trials.boehringer-ingelheim.com/

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