Inner Ear DiseasesPhase 1NCT02772796
A Single Dose PK Study of SENS-218 in Healthy Volunteers
A Phase 1 study testing SENS-218 in people with Inner Ear Diseases, run by Simbec Research.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Inner Ear Diseases
- What is being tested?
- SENS-218
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Mar 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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
About this study
Official title: An Open-label, Single-dose, Pharmacokinetic Study of SENS-218 in Healthy Adult, Caucasian Subjects.
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.
Read more
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).
Read the 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.
- Conditions
- Inner Ear Diseases
- Being tested
- SENS-218
- Keywords
- Pharmacokinetics, Healthy Volunteer Study
- Medical subject headings
- Labyrinth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SENS-218Drug
Oral Administration
| Study group | Role | What they receive |
|---|---|---|
| SENS-218 | Experimental | 2 x 10 mg administered once on Day 1. Receives: Drug: SENS-218 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax - Max plasma concentration of SENS-218 in healthy adults
Measured: 0 to 48 hours.
Tmax -Time taken to reach Cmax for SENS-218 in healthy adults
Measured: 0 to 48 hours.
kel - elimination rate constant of SENS-218 in healthy adults
Measured: 0 to 48 hours.
t1/2 - Terminal Elimination half life of SENS-218 in healthy adults
Measured: 0 to 48 hours
AUC0-t - area under the concentration-time curve (AUC) from the time of dosing to last measurable concentration of SENS-218 in healthy adults.
Measured: 0 to 48 hours
AUC0-inf - the AUC extrapolated to infinity of SENS-218 in healthy
Measured: 0 to 48 hours
CL/F - clearance, calculated as dose/AUC0-inf of SENS-218 in healthy adults.
Measured: 0 to 48 hours
MRT - Mean residence time of SENS-218 in healthy adults
Measured: 0 to 48 hours
Secondary outcomes (3)
12-lead ECGs
12-lead ECG assessments: Heart rate, PR interval, QRS width, QT interval and QT interval corrected using Bazett's formula (QTcB).
Measured: Day 1 until post study (5 to 7 days following IMP administration)
Vitals signs
Vital signs assessments: Systolic/diastolic blood pressure and pulse rate and oral body temperature. corrected using Bazett's formula (QTcB).
Measured: Day 1 until post study (5 to 7 days following IMP administration)
Physical examination
Measured: Day 1 until post study (5 to 7 days following IMP administration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2016 (estimated)
- Study startFeb 2016
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inner Ear DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Simbec Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sensorion SA
- Responsible party
- Principal investigator, Girish Sharma, Simbec Research
- Investigators
- Girish Sharma, MBBS, Principal investigator, Simbec Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02772796
- Sponsor's protocol ID
- RD 716/33020
- Status last verified
- May 2016
- First submitted
- 25 Apr 2016
- Last updated
- 16 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-dose, Pharmacokinetic Study of SENS-218 in Healthy Adult, Caucasian Subjects.
- ClinicalTrials.gov ID
- NCT02772796
- Acronym / sponsor ID
- RD 716/33020
- Conditions
- Inner Ear Diseases
- Keywords
- Pharmacokinetics, Healthy Volunteer Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Simbec ResearchIndustry (pharma, biotech, devices)
- Collaborators
- Sensorion SA
- Study start
- Feb 2016
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 16 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SENS-218 | Experimental | Drug: SENS-2182 x 10 mg administered once on Day 1. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SENS-218Oral Administration | Drug | SENS-218 |
Primary outcome
Cmax - Max plasma concentration of SENS-218 in healthy adults
Time frame: 0 to 48 hours.
Tmax -Time taken to reach Cmax for SENS-218 in healthy adults
Time frame: 0 to 48 hours.
kel - elimination rate constant of SENS-218 in healthy adults
Time frame: 0 to 48 hours.
t1/2 - Terminal Elimination half life of SENS-218 in healthy adults
Time frame: 0 to 48 hours
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
AUC0-inf - the AUC extrapolated to infinity of SENS-218 in healthy
Time frame: 0 to 48 hours
CL/F - clearance, calculated as dose/AUC0-inf of SENS-218 in healthy adults.
Time frame: 0 to 48 hours
MRT - Mean residence time of SENS-218 in healthy adults
Time frame: 0 to 48 hours
3 secondary outcomes
12-lead ECGs
Time frame: Day 1 until post study (5 to 7 days following IMP administration)
Vitals signs
Time frame: Day 1 until post study (5 to 7 days following IMP administration)
Physical examination
Time frame: Day 1 until post study (5 to 7 days following IMP administration)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Girish Sharma, MBBS principal investigator
Simbec Research
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SENS-218 in people with Inner Ear Diseases, run by Simbec Research.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax - Max plasma concentration of SENS-218 in healthy adults (time frame: 0 to 48 hours.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2016.