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Pharmacokinetics and Safety of BI 695501 Administered Via Prefilled Syringe or Autoinjector

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: NCT02606903
Recruitment Status : Completed
First Posted : November 17, 2015
Results First Posted : December 27, 2018
Last Update Posted : December 27, 2018
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE November 16, 2015
First Posted Date  ICMJE November 17, 2015
Results First Submitted Date  ICMJE September 11, 2017
Results First Posted Date  ICMJE December 27, 2018
Last Update Posted Date December 27, 2018
Actual Study Start Date  ICMJE October 28, 2015
Actual Primary Completion Date September 7, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 13, 2018)
  • Maximum Measured Concentration of BI 695501 in Plasma (Cmax) [ Time Frame: PK plasma samples were taken at: 1 hour (h) before drug administration and 1h, 4h, 8h,12h, 24h, 48h, 60h, 72h, 84h, 96h, 108h, 120h, 132h, 144h, 168h, 216h, 336h, 504h, 672h, 840h, 1008h after drug administration. ]
    Maximum measured concentration of BI 695501 in plasma (Cmax). The rate and extent of absorption of BI 695501 by assessment of maximum plasma concentration following administration via AI or via PFS of a single dose of 40 mg BI 695501. During analysis, it was realized that the PK sample on Day 43 had originally been mistakenly associated with a 1032 h time point, rather than with 1008 h. However, PK parameters are calculated using actual values so this did not impact the analysis results.
  • Area Under the Concentration-time Curve of the BI 695501 in Plasma Over the Time Interval From 0 to 1032 Hours After Dose (AUC0-1032) [ Time Frame: PK plasma samples were taken at: 1 hour (h) before drug administration and 1h, 4h, 8h,12h, 24h, 48h, 60h, 72h, 84h, 96h, 108h, 120h, 132h, 144h, 168h, 216h, 336h, 504h, 672h, 840h, 1008h after drug administration. ]
    Area under the concentration-time curve of the BI 695501 in plasma over the time interval from 0 to 1032 hours after dose (AUC0-1032). The rate and extent of absorption of BI 695501 by assessment of AUC0-1032 following administration via AI or via PFS of a single dose of 40 mg BI 695501. During analysis, it was realized that the PK sample on Day 43 had originally been mistakenly associated with a 1032 h time point, rather than with 1008 h. However, PK parameters are calculated using actual values so this did not impact the analysis results.
  • Area Under the Concentration-time Curve of the BI 695501 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity) [ Time Frame: PK plasma samples were taken at: 1 hour (h) before drug administration and 1h, 4h, 8h,12h, 24h, 48h, 60h, 72h, 84h, 96h, 108h, 120h, 132h, 144h, 168h, 216h, 336h, 504h, 672h, 840h, 1008h after drug administration. ]
    Area under the concentration-time curve of the BI 695501 in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity) based on observed concentration at time of last measurable concentration. The rate and extent of absorption of BI 695501 by assessment of (AUC0-∞) following administration via AI or via PFS of a single dose of 40 mg BI 695501. During analysis, it was realized that the PK sample on Day 43 had originally been mistakenly associated with a 1032 h time point, rather than with 1008 h. However, PK parameters are calculated using actual values so this did not impact the analysis results.
Original Primary Outcome Measures  ICMJE
 (submitted: November 16, 2015)
  • Cmax [ Time Frame: 0 to 1032 hours after dose ]
  • AUC 0-1032 [ Time Frame: 0 to 1032 hours after dose ]
  • AUC 0-inf [ Time Frame: 0 to 1032 hours after dose ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2018)
Number of Subjects With Drug-related Adverse Events (AEs) [ Time Frame: From the first drug administration until 43 days observation period after drug administration and up to 70 days safety follow up period ]
Number of subjects with drug-related Adverse Events (AEs). Any event with an onset after the administration of the trial medication up to a period of 70 days was defined as a treatment-emergent AE (TEAE). A treatment-related AE was defined as any TEAE assessed by the investigator as related to the trial medication.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2015)
Number (proportion) of subjects with drug-related AEs [ Time Frame: Day 1 through Day 70 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetics and Safety of BI 695501 Administered Via Prefilled Syringe or Autoinjector
Official Title  ICMJE Randomized, Single-dose, Parallel-arm, Open-label Phase I Trial to Investigate and Compare the Pharmacokinetics, Safety and Tolerability of BI 695501 Administered Subcutaneously Via Prefilled Syringe or Autoinjector
Brief Summary To investigate and compare the pharmacokinetics, safety and tolerability of BI 695501 administered subcutaneously via prefilled syringe or autoinjector
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: BI 695501 prefilled syringe
  • Drug: BI 695501 autoinjector
Study Arms  ICMJE
  • Experimental: BI 695501 prefilled syringe
    Intervention: Drug: BI 695501 prefilled syringe
  • Experimental: BI 695501 autoinjector
    Intervention: Drug: BI 695501 autoinjector
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 7, 2017)
71
Original Estimated Enrollment  ICMJE
 (submitted: November 16, 2015)
66
Actual Study Completion Date  ICMJE October 4, 2016
Actual Primary Completion Date September 7, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  • Healthy male, non-athletic* Caucasian 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]), 12-lead ECG, and clinical laboratory tests.
  • Age between 18 and 65 years (inclusive)
  • BMI of 18 to 30 kg/m2 (inclusive)
  • BMI 18 to <20, or
  • BMI 20 to <25, or
  • BMI 25 to <=30
  • Signed and dated written informed consent prior to admission to the trial in accordance with Good Clinical Practice (GCP) and local legislation.
  • Subjects agree to use an acceptable method of contraception during the trial and for 6 month after the dose of trial drug.

    • Non-athletic defined as person performing no more than one hour of exercise per week

Exclusion criteria:

  • Any finding in the medical examination (including BP, PR or ECG) that deviates from normal and judged as clinically relevant by the investigator.
  • Any evidence of a concomitant disease judged as clinically relevant by the investigator including gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, hormonal disorders or 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.
  • Positive result for HIV, HBV, and hepatitis C (Hep C) at screening.
  • History of relevant allergy or hypersensitivity including allergy to the trial medication, its excipients or device materials (e.g. natural rubber or latex).
  • Intake of drugs with a long half-life (more than 24 hours) within 30 days or less than 5 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.
  • Previous exposure to a biologic drug.
  • Intake of an investigational drug in another trial within 2 months prior to intake of trial medication in this trial or intake of an investigational drug during the course of this trial.
  • Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day).
  • Inability to refrain from smoking during days of confinement at the trial site.
  • Alcohol abuse (consumption of more than 4 units/day).
  • Unwillingness/inability to refrain from intake of alcoholic beverages from 48 hours prior to the trial medication administration and until Day 14 post trial medication administration; and/or to limit alcohol intake to a maximum of 3 units per day until e.o.t.
  • 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 1 week prior to administration of trial medication or contact sport during the entire trial and unwilling to avoid vigorous exercise for 14 days post dosing.
  • Inability to comply with dietary regimen of trial site.
  • Any out-of-range laboratory values considered clinically significant by the investigator; subjects with creatine kinase (CK) values 2 times the upper limit of normal (ULN) at Day -1 are excluded from participation.
  • Subject is assessed as unsuitable for inclusion by the investigator, for instance, because he is considered not able to understand and comply with trial requirements, or has a condition that would not allow safe participation in the trial.
  • Subjects with any immunological disorders or auto-immune disorders, (e.g., RA, lupus erythematosus, scleroderma, etc.).
  • Subject has received a live vaccine within 12 weeks prior to enrolling in the trial.
  • History of TB or positive finding in IGRA.
  • Evidence of skin irritation or infection at the planned injection place.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02606903
Other Study ID Numbers  ICMJE 1297.6
2015-003029-32 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP