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A Single Dose PK Study of SENS-218 in Healthy Volunteers

Primary Purpose

Inner Ear Diseases

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
SENS-218
Sponsored by
Simbec Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Inner Ear Diseases focused on measuring Pharmacokinetics, Healthy Volunteer Study

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Healthy Caucasian males and females (non-pregnant/non-lactating) between 18 and 50 years of age.
  2. Female subject of child bearing potential with a negative pregnancy test at the screening visit and willing to use 2 effective methods of contraception, from first dose until 3 months afterwards (i.e., until 3 months after taking IMP).
  3. Female subject of non-child bearing potential with with negative pregnancy test at the screening visit.

    For the purposes of this study, this is defined as the subject being amenorrheic for at least 12 consecutive months or at least 4 months post-surgical sterilisation (including bilateral fallopian tube ligation or bilateral oophorectomy with or without hysterectomy) and levels of follicle stimulating hormone (FSH) falling within the respective pathology reference range. In the event a subject's menopause status has been clearly established (for example, the subject indicates she has been amenorrheic for 10 years), but FSH levels are not consistent with a post-menopausal condition, determination of subject eligibility will be at the discretion of the Investigator following consultation with the Sponsor's Responsible Physician.

  4. Male subject willing to use 2 effective methods of contraception, (unless anatomically sterile) from first dose until 3 months afterwards (i.e., until 3 months after taking IMP).
  5. Subject with a body mass index (BMI) of 18-30 kg/m2. BMI = body weight (kg)/height (m)2.
  6. Subject with no clinically significant abnormal serum biochemistry, haematology and urine examination values within 14 days of the first dose.
  7. Subject with a negative urinary drugs of abuse screen, determined within 14 days of the first dose (a positive alcohol result may be repeated at the discretion of the Investigator).
  8. Subject with negative human immunodeficiency virus (HIV), hepatitis B surface antigen (Hep B) and hepatitis C virus antibody (Hep C) results.
  9. Subject with no clinically significant abnormalities in 12-lead electrocardiogram (ECG) determined within 14 days of the first dose.
  10. Subject with no clinically significant abnormalities in blood pressure or pulse determined within 14 days of the first dose.
  11. Subject is a non-smoker or ex-smoker who has not smoked in the last 3 months (determined by urine cotinine < 500 ng/mL at screening visit).
  12. Subject is available to complete the study (including all follow-up visits) and comply with study restrictions.
  13. Subject satisfies a medical examiner about their fitness to participate in the study.
  14. Subject provides written informed consent to participate in the study.

Exclusion Criteria:

  1. Subject with a clinically significant history of gastrointestinal disorder likely to influence drug absorption.
  2. Subject in receipt of regular medication (with the exception of contraception) within 14 days of the first dose that may have an impact on the safety and objectives of the study (Investigator's discretion).
  3. Subject with evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
  4. Subjects with any renal (serum creatinine (CREAT) level > 1.5 fold above the upper limit of normal (ULN)) or liver insufficiency (alkaline phosphatase (ALP) level > 1.2 fold above ULN, gamma glutamyl transferase (GGT), aspartate transaminase (AST), or alanine transaminase (ALT) level > 2.5 fold above ULN, and total bilirubin (BIL-T) level > 1.5 fold above ULN).
  5. Subject with history of, or family history (immediate relative) of, long QT syndrome or Torsade de Pointes or symptomatic bradycardia.
  6. Subject with clinically significant history of previous allergy / sensitivity to SENS-218 or its excipients or other 5-hydroxytryptophan3 (5-HT3) receptor antagonists.
  7. Subject with a clinically significant history of drug or alcohol abuse.
  8. Subject with inability to communicate well with the Investigator (i.e., language problem, poor mental development or impaired cerebral function).
  9. Subject participation in a New Chemical Entity clinical study within the previous 4 months or a marketed drug clinical study within the previous 3 months. (N.B. washout period between studies is defined as the period of time elapsed between the last dose of the previous study and the first dose of the next study).
  10. Subject donated 450 mL or more blood within the previous 3 months

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    SENS-218

    Arm Description

    2 x 10 mg administered once on Day 1.

    Outcomes

    Primary Outcome Measures

    Cmax - Max plasma concentration of SENS-218 in healthy adults
    Tmax -Time taken to reach Cmax for SENS-218 in healthy adults
    kel - elimination rate constant of SENS-218 in healthy adults
    t1/2 - Terminal Elimination half life of SENS-218 in healthy adults
    AUC0-t - area under the concentration-time curve (AUC) from the time of dosing to last measurable concentration of SENS-218 in healthy adults.
    AUC0-inf - the AUC extrapolated to infinity of SENS-218 in healthy
    CL/F - clearance, calculated as dose/AUC0-inf of SENS-218 in healthy adults.
    MRT - Mean residence time of SENS-218 in healthy adults

    Secondary Outcome Measures

    12-lead ECGs
    12-lead ECG assessments: Heart rate, PR interval, QRS width, QT interval and QT interval corrected using Bazett's formula (QTcB).
    Vitals signs
    Vital signs assessments: Systolic/diastolic blood pressure and pulse rate and oral body temperature. corrected using Bazett's formula (QTcB).
    Physical examination

    Full Information

    First Posted
    April 25, 2016
    Last Updated
    May 11, 2016
    Sponsor
    Simbec Research
    Collaborators
    Sensorion SA
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02772796
    Brief Title
    A Single Dose PK Study of SENS-218 in Healthy Volunteers
    Official Title
    An Open-label, Single-dose, Pharmacokinetic Study of SENS-218 in Healthy Adult, Caucasian Subjects.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2016 (undefined)
    Primary Completion Date
    March 2016 (Actual)
    Study Completion Date
    March 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Simbec Research
    Collaborators
    Sensorion SA

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study is to aid the development for the use of SENS-218 outside its marketed therapeutic indications. SENS-218 is available in Asia and is marketed as an anti-emetic (Anti-sickness) drug often prescribed after exposure to chemotherapy. Chemotherapy exposure can often induce nausea and/or vomiting. The study only involves the one drug, referred to as SENS-218 in this study. The purpose of the study is to support the development of use of SENS-218 in non-Asian population. The key objective of this study is to identify the pharmacokinetic (PK) parameters of the drug in healthy Caucasian population. The PK refers to what the body does to the body, for example, how quickly the drug is absorbed into the blood stream. The population who are eligible to take part in the study are healthy male and female, non-smoking volunteers, aged between 18 and 50 years, as determined by screening tests at Simbec. Participation in the trial will last for about 3 weeks (from first screening visit to final end of study visit).
    Detailed Description
    This study consists of a screening visit, 1 treatment period and a post study visit. These are outlined below: Screening visit ( Day -14 to Day -1) - Ensure subjects are eligible for the study. Treatment period 1 -If all screening assessments are satisfactory, subjects will be invited to attend Simbec to take part in the study. The treatment period consists of 2 overnight stays (Day -1 until the morning of Day 2). One return visit is required at the 48 hour point post dose on Day 3. Post study visit -Subjects will be asked to attend Simbec 5-7 days after administration of the last dose for a post study visit. If you are withdrawn from the study, you will still be asked to attend for an end of study assessment. Subjects may be asked to return again if we need to follow you up.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Inner Ear Diseases
    Keywords
    Pharmacokinetics, Healthy Volunteer Study

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    24 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    SENS-218
    Arm Type
    Experimental
    Arm Description
    2 x 10 mg administered once on Day 1.
    Intervention Type
    Drug
    Intervention Name(s)
    SENS-218
    Intervention Description
    Oral Administration
    Primary Outcome Measure Information:
    Title
    Cmax - Max plasma concentration of SENS-218 in healthy adults
    Time Frame
    0 to 48 hours.
    Title
    Tmax -Time taken to reach Cmax for SENS-218 in healthy adults
    Time Frame
    0 to 48 hours.
    Title
    kel - elimination rate constant of SENS-218 in healthy adults
    Time Frame
    0 to 48 hours.
    Title
    t1/2 - Terminal Elimination half life of SENS-218 in healthy adults
    Time Frame
    0 to 48 hours
    Title
    AUC0-t - area under the concentration-time curve (AUC) from the time of dosing to last measurable concentration of SENS-218 in healthy adults.
    Time Frame
    0 to 48 hours
    Title
    AUC0-inf - the AUC extrapolated to infinity of SENS-218 in healthy
    Time Frame
    0 to 48 hours
    Title
    CL/F - clearance, calculated as dose/AUC0-inf of SENS-218 in healthy adults.
    Time Frame
    0 to 48 hours
    Title
    MRT - Mean residence time of SENS-218 in healthy adults
    Time Frame
    0 to 48 hours
    Secondary Outcome Measure Information:
    Title
    12-lead ECGs
    Description
    12-lead ECG assessments: Heart rate, PR interval, QRS width, QT interval and QT interval corrected using Bazett's formula (QTcB).
    Time Frame
    Day 1 until post study (5 to 7 days following IMP administration)
    Title
    Vitals signs
    Description
    Vital signs assessments: Systolic/diastolic blood pressure and pulse rate and oral body temperature. corrected using Bazett's formula (QTcB).
    Time Frame
    Day 1 until post study (5 to 7 days following IMP administration)
    Title
    Physical examination
    Time Frame
    Day 1 until post study (5 to 7 days following IMP administration)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy Caucasian males and females (non-pregnant/non-lactating) between 18 and 50 years of age. Female subject of child bearing potential with a negative pregnancy test at the screening visit and willing to use 2 effective methods of contraception, from first dose until 3 months afterwards (i.e., until 3 months after taking IMP). Female subject of non-child bearing potential with with negative pregnancy test at the screening visit. For the purposes of this study, this is defined as the subject being amenorrheic for at least 12 consecutive months or at least 4 months post-surgical sterilisation (including bilateral fallopian tube ligation or bilateral oophorectomy with or without hysterectomy) and levels of follicle stimulating hormone (FSH) falling within the respective pathology reference range. In the event a subject's menopause status has been clearly established (for example, the subject indicates she has been amenorrheic for 10 years), but FSH levels are not consistent with a post-menopausal condition, determination of subject eligibility will be at the discretion of the Investigator following consultation with the Sponsor's Responsible Physician. Male subject willing to use 2 effective methods of contraception, (unless anatomically sterile) from first dose until 3 months afterwards (i.e., until 3 months after taking IMP). Subject with a body mass index (BMI) of 18-30 kg/m2. BMI = body weight (kg)/height (m)2. Subject with no clinically significant abnormal serum biochemistry, haematology and urine examination values within 14 days of the first dose. Subject with a negative urinary drugs of abuse screen, determined within 14 days of the first dose (a positive alcohol result may be repeated at the discretion of the Investigator). Subject with negative human immunodeficiency virus (HIV), hepatitis B surface antigen (Hep B) and hepatitis C virus antibody (Hep C) results. Subject with no clinically significant abnormalities in 12-lead electrocardiogram (ECG) determined within 14 days of the first dose. Subject with no clinically significant abnormalities in blood pressure or pulse determined within 14 days of the first dose. Subject is a non-smoker or ex-smoker who has not smoked in the last 3 months (determined by urine cotinine < 500 ng/mL at screening visit). Subject is available to complete the study (including all follow-up visits) and comply with study restrictions. Subject satisfies a medical examiner about their fitness to participate in the study. Subject provides written informed consent to participate in the study. Exclusion Criteria: Subject with a clinically significant history of gastrointestinal disorder likely to influence drug absorption. Subject in receipt of regular medication (with the exception of contraception) within 14 days of the first dose that may have an impact on the safety and objectives of the study (Investigator's discretion). Subject with evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction. Subjects with any renal (serum creatinine (CREAT) level > 1.5 fold above the upper limit of normal (ULN)) or liver insufficiency (alkaline phosphatase (ALP) level > 1.2 fold above ULN, gamma glutamyl transferase (GGT), aspartate transaminase (AST), or alanine transaminase (ALT) level > 2.5 fold above ULN, and total bilirubin (BIL-T) level > 1.5 fold above ULN). Subject with history of, or family history (immediate relative) of, long QT syndrome or Torsade de Pointes or symptomatic bradycardia. Subject with clinically significant history of previous allergy / sensitivity to SENS-218 or its excipients or other 5-hydroxytryptophan3 (5-HT3) receptor antagonists. Subject with a clinically significant history of drug or alcohol abuse. Subject with inability to communicate well with the Investigator (i.e., language problem, poor mental development or impaired cerebral function). Subject participation in a New Chemical Entity clinical study within the previous 4 months or a marketed drug clinical study within the previous 3 months. (N.B. washout period between studies is defined as the period of time elapsed between the last dose of the previous study and the first dose of the next study). Subject donated 450 mL or more blood within the previous 3 months
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Girish Sharma, MBBS
    Organizational Affiliation
    Simbec Research
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    A Single Dose PK Study of SENS-218 in Healthy Volunteers

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