- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02331277
Safety and Pharmacokinetics of Multiple Doses of BI 655064 in Healthy Chinese Male Volunteers
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Subcutaneous Doses of BI 655064 in Healthy Chinese Male Volunteers (Randomised, Double-blind, Placebo-controlled, Clinical Phase I Study)
The primary objective of this trial is to investigate the safety and tolerability of multiple doses of BI 655064 following weekly subcutaneous injection for 4 weeks in healthy Chinese male volunteers.
The secondary objective is the exploratory evaluation of the pharmacokinetics and pharmacodynamics of multiple doses of BI 655064 following weekly subcutaneous injection for 4 weeks in healthy Chinese male volunteers.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Seoul, Korea, Republic of
- 1293.9.8201 Boehringer Ingelheim Investigational Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion criteria:
- Healthy males according to the investigator's assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs (Blood pressure, Pulse rate), 12-lead Echocardiogram, and clinical laboratory tests
Chinese ethnicity according to the following criteria:
Ethnic Chinese, born in China or ethnic Chinese born outside of China, and a descendent of 4 ethnic Chinese grandparents who were all born in China
- Age within the range of 20 to 45 years inclusive
- Body Mass Index within the range of 18.5 and 25 kg/m2 inclusive
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation
Male subjects who
- are documented to be sterile or consistently and correctly use a condom while their female partners (if of childbearing potential) agree to use any of the following adequate contraception methods: implants, injectables, combined oral contraceptives, intrauterine device (IUD) from the date of screening until at least 6 months after the last dose of BI 655064 taken in the current trial.
- do not donate any sperm sample for procreation purposes, from the date of screening until at least 6 months after last dose of BI 655064 taken in the current trial.
It is the responsibility of the male subject to ensure that his partner does not become pregnant during all the study duration.
Exclusion criteria:
- Any finding in the medical examination (including Blood pressure, Pulse rate or Echocardiogram) deviating from normal and judged 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 clinically relevant by the investigator
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders
- History of relevant orthostatic hypotension, fainting spells, or blackouts
- History of relevant allergy/hypersensitivity (including allergy to the trial medication or its excipients)
- Intake of drugs with a long half-life (>24 hours) within 30 days or less than 10 half-lives of the respective drug prior to administration of trial medication
- Within 10 days prior to administration of trial medication, use of drugs that might reasonably influence the results of the trial
- Participation in another trial with investigational drug administration within 60 days prior to administration of trial medication
- Smoker (more than 10 cigarettes or 3 cigars or 3 pipes/day)
- Inability to refrain from smoking on trial days
- Alcohol abuse (consumption of more than 20 g/day)
- Drug abuse or positive drug screen
- Blood donation (more than 100 mL within 30 days prior to administration of trial medication or intended during the trial)
- Intention to commence new exercise regimen or excessive physical activities within one week prior to administration of trial medication or during the trial
- Inability to comply with protocol requirements (including dietary regimen of trial site) as assessed by the investigator
- A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of QTc interval > 450 ms) at screening examination
- Positive results of infectious serology (Hepatitis B Surface Antigen, Hepatitis B Core Antibody, Hepatitis C Antibody or Human Immunodeficiency Virus) at screening examination
- History of tuberculosis infection and/or positive Quantiferon Tuberculosis-Gold test at screening examination
- Abnormal results of coagulation values indicating an increased risk for bleeding or thromboembolism or complicating the safety evaluation during the study as determined by the investigator at screening examination
- Subjects who in the investigator's judgement are perceived as having an excessive risk of thromboembolism for example because of a personal history and/or a first degree relative with a personal history with onset under the age of 55 of significant thromboembolism, including but not limited to deep vein thrombosis, pulmonary embolism, cortical sinus thrombosis, coronary and cerebrovascular events, and peripheral arterial insufficiency.
- Deficiency of antithrombin III or protein S or protein C at screening examination
- Prolongation of bleeding time out of reference range at screening examination
- Subject is assessed by the investigator as unsuitable for inclusion e.g. considered not able to understand and comply with study requirements or has a condition that would not allow safe participation in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: BI 655064
Subjects received BI 655064 240 milligram (mg) via subcutaneous injection every week, until 4 weeks.
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subcutaneous injection
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Placebo Comparator: Placebo
Subjects received placebo matching to BI 655064 via subcutaneous injection every week, until 4 weeks.
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Placebo
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Subjects With Drug-related Adverse Events.
Time Frame: From the first drug administration until 126 days after last drug administration, up to 148 days.
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Percentage of subjects with drug-related adverse events (AEs).
Medical judgment was used to determine the relationship between study medication and AEs, considering all relevant factors, including pattern of reaction, temporal relationship, de-challenge or re-challenge, confounding factors such as concomitant medication, concomitant diseases and relevant history.
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From the first drug administration until 126 days after last drug administration, up to 148 days.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Maximum Measured Concentration of BI 655064 in Plasma After the 1st Dose (Cmax)
Time Frame: Pharmacokinetic samples were collected at -3, 8, 12, 24, 48, 72, 84, 96, 108, 120, 144 and 167.5 hours (h) after first drug administration on day 1.
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Maximum measured concentration of BI 655064 in plasma after the 1st dose (Cmax).
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Pharmacokinetic samples were collected at -3, 8, 12, 24, 48, 72, 84, 96, 108, 120, 144 and 167.5 hours (h) after first drug administration on day 1.
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Time From Dosing to Maximum Measured Concentration of BI 655064 in Plasma After the 1st Dose (Tmax)
Time Frame: Pharmacokinetic samples were collected at -3, 8, 12, 24, 48, 72, 84, 96, 108, 120, 144 and 167.5 h after first drug administration on day 1.
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Time from dosing to maximum measured concentration of BI 655064 in plasma after the 1st dose (tmax).
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Pharmacokinetic samples were collected at -3, 8, 12, 24, 48, 72, 84, 96, 108, 120, 144 and 167.5 h after first drug administration on day 1.
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Area Under the Concentration-time Curve of BI 655064 in Plasma After the 1st Dose Over a Uniform Dosing Interval τ (AUCτ,1)
Time Frame: Pharmacokinetic samples were collected at -3, 8, 12, 24, 48, 72, 84, 96, 108, 120, 144 and 167.5 h after first drug administration on day 1.
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Area under the concentration-time curve of BI 655064 in plasma after the 1st dose over a uniform dosing interval τ (= 1 week) (AUCτ,1).
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Pharmacokinetic samples were collected at -3, 8, 12, 24, 48, 72, 84, 96, 108, 120, 144 and 167.5 h after first drug administration on day 1.
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Maximum Measured Concentration of BI 655064 in Plasma After the 4th Dose (Cmax,4)
Time Frame: Pharmacokinetic samples were collected at 505, 516, 528, 552, 576, 600, 624, 648, 672, 696, 744, 816, 912, 1008, 1176, 1344, 1512, 1848, 2520 and 3192 h after fourth drug administration on day 22.
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Maximum measured concentration of BI 655064 in plasma after the 4th dose (Cmax,4).
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Pharmacokinetic samples were collected at 505, 516, 528, 552, 576, 600, 624, 648, 672, 696, 744, 816, 912, 1008, 1176, 1344, 1512, 1848, 2520 and 3192 h after fourth drug administration on day 22.
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Time From Dosing to Maximum Measured Concentration of BI 655064 in Plasma After the 4th Dose (Tmax,4)
Time Frame: Pharmacokinetic samples were collected at 505, 516, 528, 552, 576, 600, 624, 648, 672, 696, 744, 816, 912, 1008, 1176, 1344, 1512, 1848, 2520 and 3192 h after fourth drug administration on day 22.
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Time from dosing to maximum measured concentration of BI 655064 in plasma after the 4th dose (tmax,4).
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Pharmacokinetic samples were collected at 505, 516, 528, 552, 576, 600, 624, 648, 672, 696, 744, 816, 912, 1008, 1176, 1344, 1512, 1848, 2520 and 3192 h after fourth drug administration on day 22.
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Area Under the Concentration-time Curve of BI 655064 in Plasma After the 4th Dose Over a Uniform Dosing Interval τ (AUCτ,4)
Time Frame: Pharmacokinetic samples were collected at 505, 516, 528, 552, 576, 600, 624, 648, 672, 696, 744, 816, 912, 1008, 1176, 1344, 1512, 1848, 2520 and 3192 h after fourth drug administration on day 22.
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Area under the concentration-time curve of BI 655064 in plasma after the 4th dose over a uniform dosing interval τ (= 1 week) (AUCτ,4).
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Pharmacokinetic samples were collected at 505, 516, 528, 552, 576, 600, 624, 648, 672, 696, 744, 816, 912, 1008, 1176, 1344, 1512, 1848, 2520 and 3192 h after fourth drug administration on day 22.
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Accumulation Ratio of BI 655064 in Plasma After Administration of the 4th Dose Over the Dosing Interval τ, Expressed as Ratio of Cmax After the 4th Dose and After the 1st Dose (RA,Cmax,4)
Time Frame: Pharmacokinetic samples were collected at -3, 8, 12, 24, 48, 72, 84, 96, 108, 120, 144 and 167.5 h for Cmax and 505, 516, 528, 552, 576, 600, 624, 648, 672, 696, 744, 816, 912, 1008, 1176, 1344, 1512, 1848, 2520, 3192 and 5880 h for Cmax,4.
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Accumulation ratio of BI 655064 in plasma after administration of the 4th dose over the dosing interval τ (= 1 week), expressed as ratio of Cmax after the 4th dose and after the 1st dose (RA,Cmax,4).
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Pharmacokinetic samples were collected at -3, 8, 12, 24, 48, 72, 84, 96, 108, 120, 144 and 167.5 h for Cmax and 505, 516, 528, 552, 576, 600, 624, 648, 672, 696, 744, 816, 912, 1008, 1176, 1344, 1512, 1848, 2520, 3192 and 5880 h for Cmax,4.
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Accumulation Ratio of BI 655064 in Plasma After Administration of the 4th Dose Over the Dosing Interval τ, Expressed as Ratio of AUC After the 4th Dose and After the 1st Dose (RA,AUC,4)
Time Frame: Pharmacokinetic samples were collected at -3, 8, 12, 24, 48, 72, 84, 96, 108, 120, 144 and 167.5 h for AUCτ,1 and 505, 516, 528, 552, 576, 600, 624, 648, 672, 696, 744, 816, 912, 1008, 1176, 1344, 1512, 1848, 2520, 3192 and 5880 h for AUCτ,4.
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Accumulation ratio of BI 655064 in plasma after administration of the 4th dose over the dosing interval τ (= 1 week), expressed as ratio of AUC after the 4th dose and after the 1st dose (RA,AUC,4).
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Pharmacokinetic samples were collected at -3, 8, 12, 24, 48, 72, 84, 96, 108, 120, 144 and 167.5 h for AUCτ,1 and 505, 516, 528, 552, 576, 600, 624, 648, 672, 696, 744, 816, 912, 1008, 1176, 1344, 1512, 1848, 2520, 3192 and 5880 h for AUCτ,4.
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Boehringer Ingelheim, Boehringer Ingelheim
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1293.9
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD 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. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to: https://www.mystudywindow.com/msw/datatransparency
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