Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06378125
Status:
RECRUITING
Last Update Posted:
2024-04-22
First Post:
2024-04-17
Brief Title:
Evaluation of Safety and Pharmacokinetics of Oral Controlled-ileal-release Nicotinic Acid CIR-NA Compared to Immediate-release Nicotinic Acid and Placebo in Healthy Subjects and Subjects With Prediabetes
Sponsor:
University Hospital Schleswig-Holstein
Organization:
University Hospital Schleswig-Holstein
Study Overview
Official Title:
A Phase I Double-blind Randomised Placebo-controlled Single-ascending and Multiple-ascending Dose Trial to Evaluate the Safety and Pharmacokinetics of Oral Controlled-ileal-release Nicotinic Acid CIR-NA Compared to Immediate-release Nicotinic Acid and Placebo in Healthy Subjects and Subjects With Prediabetes
Status:
RECRUITING
Status Verified Date:
2024-04
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:
A double-blind randomised placebo-controlled single-ascending and multiple-ascending dose trial to evaluate the safety and pharmacokinetics of oral controlled-ileal-release nicotinic acid CIR-NA compared to immediate-release nicotinic acid and placebo in healthy subjects and subjects with prediabetes
Detailed Description:
Recently administration of one form of vitamin B3 Nicotinamide NAM has been shown to improve the host-microbiome interaction in a mouse model especially when administered in a controlled-release formulation targeting the ileocolic region Thus NAM and also the other form of vitamin B3 Nicotinicacid NA were identified as promising candidates for a gut-targeted microbiome intervention
As the upper gastrointestinal tract efficiently absorbs amino acids and vitamins simply increasing the NA andor NAM content in human food would not be expected to deliver these molecules in sufficient amounts into the lower ileum and colon where most of the microbiota are located Moreover adverse effects such as flushing or gastrointestinal symptoms can occur under high and immediately systemically available dosage of NA Therefore the novel CIR-NA formulation will be applied to deliver NA to the lower ileum and colon to tar-get the gut microbiome while largely avoiding systemic exposure as the terminal ileum and colon have a much lower absorptive capacity than the stomach and upper small intestine
Both in the single- and multiple-ascending SADMAD part of the study CIR-NA or placebo tablets will be self-administered orally with daily doses of 100 mg 1 tablet 200 mg 2 tablets 500 mg 5 tablets or 1000 mg CIR-NA 10 tablets or the corresponding amounts of placebo tablets In the SAD part an additional dose of 2000 mg CIR-NA or placebo 20 tablets will be self-administeredAfter completion of the SAD and the 200 mg MAD part in healthy subjects an additional mul-tiple dose part 200 mgd CIR-NA in subjects with PreD MD-PreD part will start in parallel to the further dose groups of the MAD part
As the upper gastrointestinal tract efficiently absorbs amino acids and vitamins simply increasing the NA andor NAM content in human food would not be expected to deliver these molecules in sufficient amounts into the lower ileum and colon where most of the microbiota are located Moreover adverse effects such as flushing or gastrointestinal symptoms can occur under high and immediately systemically available dosage of NA Therefore the novel CIR-NA formulation will be applied to deliver NA to the lower ileum and colon to tar-get the gut microbiome while largely avoiding systemic exposure as the terminal ileum and colon have a much lower absorptive capacity than the stomach and upper small intestine
Both in the single- and multiple-ascending SADMAD part of the study CIR-NA or placebo tablets will be self-administered orally with daily doses of 100 mg 1 tablet 200 mg 2 tablets 500 mg 5 tablets or 1000 mg CIR-NA 10 tablets or the corresponding amounts of placebo tablets In the SAD part an additional dose of 2000 mg CIR-NA or placebo 20 tablets will be self-administeredAfter completion of the SAD and the 200 mg MAD part in healthy subjects an additional mul-tiple dose part 200 mgd CIR-NA in subjects with PreD MD-PreD part will start in parallel to the further dose groups of the MAD part
Study Oversight
Has Oversight DMC:
None
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?:
None