Clinical trial • Phase I • Other
[14C]LTP001 for Healthy volunteers
Phase I trial of [14C]LTP001 for Healthy volunteers. open-label, none/not specified-controlled. 6 participants.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Healthy volunteers
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 26-01-2026
- First CTIS Authorization Date
- 06-03-2026
Trial design
open-label, none/not specified-controlled Phase I trial across 1 site in Netherlands.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 6
Eligibility
Recruits 6 Not a vulnerable population; only healthy male participants are included (isMaleSubjects: true; isFemaleSubjects: false). No consent or assent details provided in the record..
- Vulnerable Population
- Not a vulnerable population; only healthy male participants are included (isMaleSubjects: true; isFemaleSubjects: false). No consent or assent details provided in the record.
Recruitment
- Planned Sample Size
- 6
- Recruitment Window Months
- 2
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 6
Netherlands
- Earliest CTIS Part Ii Submission Date
- 03-03-2026
- Latest Decision Or Authorization Date
- 06-03-2026
- Processing Time Days
- 3
- Number Of Sites
- 1
- Number Of Participants
- 6
Sites
- Site Name
- Pharmaceutical Research Associates Group B.V.
- Department Name
- Program Management
- Contact Person Name
- Renger Tiessen
- Contact Person Email
- Renger.Tiessen@iconplc.com
Sponsor
Primary sponsor
- Full Name
- Novartis Pharma AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- Pharmaceutical Research Associates Group B.V.
- Responsibilities
- Program Management; listed as site contact (email: Renger.Tiessen@iconplc.com)
Investigational products
- Investigational Product Name
- [14C]LTP001
- Routes Of Administration
- oral
- Route
- oral
- Frequency
- single dose
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