A Phase I, double-blind, randomised, placebo-controlled, single-ascending and multiple-ascending dose trial to evaluate safety and pharmacokinetics of oral controlled-ileocolonic-release nicotinamide (CICR-NAM) compared to immediate-release nicotinamide and placebo in healthy subjects and in patients with inflammatory bowel diseases
- Conditions
- Phase I trial with healthy subjectsInflammatory bowel diseases
- Registration Number
- DRKS00023384
- Lead Sponsor
- niversitätsklinikum Schleswig-Holstein Campus Kiel
- Brief Summary
Forty-nine subjects/patients were treated with immediate-release nicotinamide (ImR-NAM), controlled-ileocolonic-release nicotinamide (CICR-NAM) or corresponding placebos. CICR-NAM showed a good safety profile. No unexpected safety signals compared to what is already known about high-dose nicotinamide were detected throughout the study. The pharmacokinetic results of the study confirmed the expected delayed release of nicotinamide from the CICR-NAM tablets and indicated that patients with inflammatory bowel diseases have a different pharmacokinetic profile with lower exposure to nicotinamide when compared to healthy subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 49
First two study parts (single-ascending dose and multiple-ascending dose): healthy subjects;
final (third) study part (multiple doses): patients with inflammatory bowel diseases
Comorbidities and other circumstances that conflict with study participation
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and Tolerability<br>Safety and tolerability evaluation based on <br>1. Adverse Events (AEs) and Serious Adverse Events (SAEs) [every visit]<br>2. laboratory assessments (haematology, clinical chemistry, urinalysis), physical examination, vital signs,<br>electrocardiogram (ECG) [at least weekly]<br>and <br>3. local tolerability assessed by ileocolonoscopy with serial biopsies [only in the highest MAD dose<br>group before and after dosing]<br>
- Secondary Outcome Measures
Name Time Method Pharmacokinetics