Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06593743
Status:
COMPLETED
Last Update Posted:
None
First Post:
2015-06-09
Brief Title:
The Safety and Dose Response to Single Anal Doses of NRL001
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Proof of Concept Study in Healthy Volunteers to Investigate the Safety and Dose Response to a Single Dose 031 or 3 of Methoxamine NRL001applied to the Anus
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Single centre dose-finding and proof-of-concept study in healthy volunteers to assess the effects of single doses of NRL001 on the mean anal resting pressure MARP In addition the pharmacokinetics of NRL001 and subject safety are also examined
Detailed Description:
This is a single centre dose-finding and proof-of-concept study in healthy volunteers to assess the effects of single doses of NRL001 on the mean anal resting pressure MARP In addition the pharmacokinetics of NRL001 and subject safety are also examined
The study consists of four parts which evaluate different NRL001 concentrations and sites of application Treatments consist of a single local application of either 03 1 or 3 ww NRL001 gel applied peri-anally of either 1 or 3 ww NRL001 gel applied intra-anally or 1 ww NRL001 administered rectally In addition a 10 mg NRL001-containing suppository applied to the rectum is assessed
The study consists of four parts which evaluate different NRL001 concentrations and sites of application Treatments consist of a single local application of either 03 1 or 3 ww NRL001 gel applied peri-anally of either 1 or 3 ww NRL001 gel applied intra-anally or 1 ww NRL001 administered rectally In addition a 10 mg NRL001-containing suppository applied to the rectum is assessed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None