Inner Ear DiseasePhase 1NCT03071003
A Study of SENS 401 in Healthy Subjects
A Phase 1 study testing SENS-401 in people with Inner Ear Disease, run by Simbec Research at 1 site in United Kingdom.
Trial summary
Sensorion are the study sponsor and the objective of this study is to investigate the safety and pharmacokinetic (PK) profile of SENS 401 in humans after a single and repeat dose administration and to confirm that, there is no interconversion of the (R) enantiomer to the (S) enantiomer. 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 Disease
- What is being tested?
- SENS-401
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Oct 2016to 16 Oct 2017
- 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 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 last SENS-401 dose).
- Female subject of non child bearing potential 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 last SENS-401 dose).
- Subject with a body mass index (BMI) of 18 30 kg/m2. If Asians are included, BMI values will be modified to 16-23 kg/m2 (this range is considered as normal in Asian population). 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.
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- 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.
- Subject 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-hydroxytryptamine (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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Double Blind, Multiple Dose, Pharmacokinetic and Safety Study of SENS 401 in Healthy Subjects
Sensorion are the study sponsor and the objective of this study is to investigate the safety and pharmacokinetic (PK) profile of SENS 401 in humans after a single and repeat dose administration and to confirm that, there is no interconversion of the (R) enantiomer to the (S) enantiomer.
The study only involves the one drug, referred to as SENS-401.The key objective is to assess the safety of SENS 401 after multiple doses in healthy subjects.
Read more
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 to final end of study visit).
Read the detailed description
This is a randomised, double blind, multiple dose, safety and PK study. Three cohorts of 12 subjects will be administered with three different dose regimens.
Screening assessments will be carried out within 14 days before administration of the investigational medicinal product (IMP). Eligible subjects will be asked to return for the treatment period.
Cohort 1: 12 subjects will receive 29 mg SENS-401 or placebo once daily for 7 days.
Cohort 2: 12 subjects will receive 29 mg SENS-401 or placebo twice daily for 6 days and a single dose of 29 mg SENS-401 or placebo in the morning on Day 7.
Cohort 3: 12 subjects will receive 43.5 mg SENS-401 or placebo twice daily for 6 days and a single dose of 43.5 mg SENS-401 or placebo in the morning on Day 7.
Subjects will be asked to attend Simbec 5-7 days after administration of the last dose for a post study visit. If they are withdrawn from the study, they will still be asked to attend for an end of study assessment. Subjects may be asked to return again if we need to follow them up.
- Conditions
- Inner Ear Disease
- Being tested
- SENS-401, Placebo
- 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-401Drug
Oral Administration
PlaceboDrug
Oral Administration
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 SENS 401 & Placebo | Experimental | 12 subjects will receive 29 mg SENS-401 (approximately 4 male and 4 female subjects) or placebo (approximately 2 male and 2 female subjects) once daily for 7 days. Receives: Drug: SENS-401; Drug: Placebo |
| Cohort 2 SENS 401 & Placebo | Experimental | 12 subjects will receive 29 mg SENS-401 (approximately 4 male and 4 female subjects) or placebo (approximately 2 male and 2 female subjects) twice daily for 6 days and a single dose of 29 mg SENS-401 or placebo in the morning on Day 7. Receives: Drug: SENS-401; Drug: Placebo |
| Cohort 3 SENS 401 & Placebo | Experimental | 12 subjects will receive 43.5 mg SENS-401 (approximately 4 male and 4 female subjects) or placebo (approximately 2 male and 2 female subjects) twice daily for 6 days and a single dose of 43.5 mg SENS-401 or placebo in the morning on Day 7. Receives: Drug: SENS-401; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of SENS 401 after multiple doses in healthy subjects
AEs
Measured: Throughout the study until post study visit (A period of approximately 4 weeks)
Secondary outcomes (3)
Maximum Plasma Concentration [Cmax]
Cohort 1, 2 and 3 - Day 1 and Day 7 Cmax
Measured: Day 1-9
Area under the curve 0 to 24 [AUC0-24]
Cohort 1 [AUC0-12], Cohort 2 and 3 [AUC0-24]
Measured: Day 1-9
Interconversion of the (R) enantiomer (SENS-401) and (S)-enantiomer (SENS-219) in human plasma.
Individual SENS-401,SENS-219 and SENS-218 concentration-time data following administration of SENS-401 will be listed.
Measured: Day 1-9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2017
- Study start21 Oct 2016
- Primary completion21 Mar 2017
- Study completion16 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inner Ear DiseaseStudies 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
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Simbec Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sensorion
- Responsible party
- Principal investigator, Robert Adams, Simbec Research
- Investigators
- Robert Adams, MBBS, Principal investigator, Simbec Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03071003
- Sponsor's protocol ID
- RD716/33196
- Status last verified
- Apr 2019
- First submitted
- 22 Feb 2017
- Last updated
- 8 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Double Blind, Multiple Dose, Pharmacokinetic and Safety Study of SENS 401 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03071003
- Acronym / sponsor ID
- RD716/33196
- Conditions
- Inner Ear Disease
- Keywords
- Pharmacokinetics, Healthy Volunteer Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Simbec ResearchIndustry (pharma, biotech, devices)
- Collaborators
- Sensorion
- Study start
- 21 Oct 2016 (actual)
- Primary completion
- 21 Mar 2017 (actual)
- Study completion
- 16 Oct 2017 (actual)
- First posted
- 6 Mar 2017 (actual)
- 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.
Sensorion are the study sponsor and the objective of this study is to investigate the safety and pharmacokinetic (PK) profile of SENS 401 in humans after a single and repeat dose administration and to confirm that, there is no interconversion of the (R) enantiomer to the (S) enantiomer.
The study only involves the one drug, referred to as SENS-401.The key objective is to assess the safety of SENS 401 after multiple doses in healthy subjects.
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 to final end of study visit).
Detailed description
This is a randomised, double blind, multiple dose, safety and PK study. Three cohorts of 12 subjects will be administered with three different dose regimens.
Screening assessments will be carried out within 14 days before administration of the investigational medicinal product (IMP). Eligible subjects will be asked to return for the treatment period.
Cohort 1: 12 subjects will receive 29 mg SENS-401 or placebo once daily for 7 days.
Cohort 2: 12 subjects will receive 29 mg SENS-401 or placebo twice daily for 6 days and a single dose of 29 mg SENS-401 or placebo in the morning on Day 7.
Cohort 3: 12 subjects will receive 43.5 mg SENS-401 or placebo twice daily for 6 days and a single dose of 43.5 mg SENS-401 or placebo in the morning on Day 7.
Subjects will be asked to attend Simbec 5-7 days after administration of the last dose for a post study visit. If they are withdrawn from the study, they will still be asked to attend for an end of study assessment. Subjects may be asked to return again if we need to follow them up.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 SENS 401 & Placebo | Experimental | Drug: SENS-401, Drug: Placebo12 subjects will receive 29 mg SENS-401 (approximately 4 male and 4 female subjects) or placebo (approximately 2 male and 2 female subjects) once daily for 7 days. |
| Cohort 2 SENS 401 & Placebo | Experimental | Drug: SENS-401, Drug: Placebo12 subjects will receive 29 mg SENS-401 (approximately 4 male and 4 female subjects) or placebo (approximately 2 male and 2 female subjects) twice daily for 6 days and a single dose of 29 mg SENS-401 or placebo in the morning on Day 7. |
| Cohort 3 SENS 401 & Placebo | Experimental | Drug: SENS-401, Drug: Placebo12 subjects will receive 43.5 mg SENS-401 (approximately 4 male and 4 female subjects) or placebo (approximately 2 male and 2 female subjects) twice daily for 6 days and a single dose of 43.5 mg SENS-401 or placebo in the morning on Day 7. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Healthy 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 last SENS-401 dose).
- Female subject of non child bearing potential 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 last SENS-401 dose).
- Subject with a body mass index (BMI) of 18 30 kg/m2. If Asians are included, BMI values will be modified to 16-23 kg/m2 (this range is considered as normal in Asian population). BMI = body weight (kg)/height (m)2.
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.
- Subject 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-401Oral Administration | Drug | Cohort 1 SENS 401 & Placebo, Cohort 2 SENS 401 & Placebo, Cohort 3 SENS 401 & Placebo |
| PlaceboOral Administration | Drug | Cohort 1 SENS 401 & Placebo, Cohort 2 SENS 401 & Placebo, Cohort 3 SENS 401 & Placebo |
Primary outcome
Safety of SENS 401 after multiple doses in healthy subjects
Time frame: Throughout the study until post study visit (A period of approximately 4 weeks)
AEs
3 secondary outcomes
Maximum Plasma Concentration [Cmax]
Time frame: Day 1-9
Area under the curve 0 to 24 [AUC0-24]
Time frame: Day 1-9
Interconversion of the (R) enantiomer (SENS-401) and (S)-enantiomer (SENS-219) in human plasma.
Time frame: Day 1-9
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 8 Apr 2019.
- Individual participant dataSharing planned: No
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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.
Robert Adams, MBBS principal investigator
Simbec Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SENS-401 in people with Inner Ear Disease, run by Simbec Research at 1 site in United Kingdom.
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 14 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 8 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Safety of SENS 401 after multiple doses in healthy subjects (time frame: Throughout the study until post study visit (A period of approximately 4 weeks)). 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 8 Apr 2019.