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

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 - CICR-NAM Phase I

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

DRKS

Registry ID

DRKS00023384

Enrollment

Registered

2020-10-29

Start date

2020-12-04

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Phase I trial with healthy subjects Inflammatory bowel diseases

Interventions

Group 1: CICR-NAM in single-ascending doses and multiple-ascending doses (treatment period 4 weeks). Initially, pharmacokinetic comparison to immediate-release nicotinamide. Group 2: Placebo

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: First two study parts (single-ascending dose and multiple-ascending dose): healthy subjects; final (third) study part (multiple doses): patients with inflammatory bowel diseases

Exclusion criteria

Exclusion criteria: Comorbidities and other circumstances that conflict with study participation

Design outcomes

Primary

Measure	Time frame
Safety and Tolerability Safety and tolerability evaluation based on 1. Adverse Events (AEs) and Serious Adverse Events (SAEs) [every visit] 2. laboratory assessments (haematology, clinical chemistry, urinalysis), physical examination, vital signs, electrocardiogram (ECG) [at least weekly] and 3. local tolerability assessed by ileocolonoscopy with serial biopsies [only in the highest MAD dose group before and after dosing]	—

Measure

Time frame

Safety and Tolerability Safety and tolerability evaluation based on 1. Adverse Events (AEs) and Serious Adverse Events (SAEs) [every visit] 2. laboratory assessments (haematology, clinical chemistry, urinalysis), physical examination, vital signs, electrocardiogram (ECG) [at least weekly] and 3. local tolerability assessed by ileocolonoscopy with serial biopsies [only in the highest MAD dose group before and after dosing]

—

Secondary

Measure	Time frame
Pharmacokinetics	—

Countries

Germany

Contacts

Public ContactCorinna Geisler

Universitätsklinikum Schleswig-Holstein Campus Kiel

studien.nutrisys.kiel@uksh.de043150022243

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026