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Single Rising Dose Trial of BI 655130 for Healthy Japanese Male Subjects

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT03123094
Collaborator
(none)
32
Enrollment
1
Location
6
Arms
7.7
Actual Duration (Months)
4.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this trial is to investigate the safety and tolerability of BI 655130 following administration of single rising intravenous doses and single subcutaneous dose in healthy Japanese male volunteers.

Secondary objective is the exploration of the pharmacokinetics including dose proportionality of BI 655130 in healthy Japanese male volunteers.

Condition or Disease Intervention/Treatment Phase
  • Drug: BI 655130
  • Drug: Placebo
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Safety, Tolerability and Pharmacokinetics of Single Rising Intravenous Dose and Single Subcutaneous Dose of BI 655130 in Healthy Japanese Male Volunteers (Double-blind, Randomised, Placebo-controlled Design).
Actual Study Start Date :
May 16, 2017
Actual Primary Completion Date :
Jan 4, 2018
Actual Study Completion Date :
Jan 4, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: BI 655130 dose group 1 (Intravenous)

Drug: BI 655130
single dose
Experimental: BI 655130 dose group 2 (Intravenous)

Drug: BI 655130
single dose
Experimental: BI 655130 dose group 3 (Intravenous)

Drug: BI 655130
single dose
Experimental: BI 655130 dose group 4 (Subcutaneous)

Drug: BI 655130
single dose
Placebo Comparator: Matching placebo for each dose group (Intravenous)

Drug: Placebo
single dose
Placebo Comparator: Matching placebo (Subcutaneous)

Drug: Placebo
single dose

Outcome Measures

Primary Outcome Measures

  1. Number of subjects with drug-related Adverse Events [Up to 148 days]

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) for IV and SC administration [Up to 148 days]

  2. Cmax (maximum measured concentration of the analyte in plasma) for IV and SC administration [Up to 148 days]

  3. CL (total clearance of the analyte in the plasma after intravenous administration) for IV administration [Up to 148 days]

  4. Vss (Volume of distribution at steady state after intravenous administration) for IV administration [Up to 148 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 45 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Healthy male 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.

  • Japanese ethnicity, according to the following criteria:

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

  • Age of 20 to 45 years (incl.)

  • Body Mass Index [BMI] of 18.5 to 25.0 kg/m2 (incl.)

  • Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation

  • Male subjects who agree to minimize the risk of female partners being pregnant by fulfilling any of the following criteria starting from the first administration of trial medication and until 30 days after trial completion:

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

combined oral contraceptives, intrauterine device

  • A vasectomised sexual partner (vasectomy at least 1 year prior to enrolment)

  • Surgically sterilised (including hysterectomy) 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 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 45 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 judged as clinically relevant by the investigator

  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

  • 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 including active tuberculosis, HIV or viral hepatitis; QuantiFERON TB test will be performed at screening.

  • 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 5 half-lives prior to planned administration of trial medication, or current participation in another trial involving administration of investigational drug.

  • Administered live vaccine within 6 weeks prior to randomisation or Have plans for administration of live vaccines during the study period.

  • 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 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

  • 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 ms in males) or any other relevant Electrocardiogram [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

  • Further exclusion criteria apply

Contacts and Locations

Locations

Site City State Country Postal Code
1 Inje University Busan Paik Hospital Busan Korea, Republic of 47392

Sponsors and Collaborators

  • Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT03123094
Other Study ID Numbers:
  • 1368-0009
First Posted:
Apr 21, 2017
Last Update Posted:
Jan 10, 2018
Last Verified:
Jan 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jan 10, 2018