Ignite Creation Date:
2025-12-24 @ 7:30 PM
Ignite Modification Date:
2025-12-28 @ 4:11 PM
Study NCT ID:
NCT03071003
Status:
COMPLETED
Last Update Posted:
2019-04-08
First Post:
2017-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of SENS 401 in Healthy Subjects
Sponsor:
Simbec Research
Organization:
Study Overview
Official Title:
A Randomised Double Blind, Multiple Dose, Pharmacokinetic and Safety Study of SENS 401 in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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).
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: