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CompletedNCT05258474Updated Nov 8, 2022

Safety and Pharmacokinetics of Oral Controlled-ileocolonic-release Nicotinamide (CICR-NAM)

A Phase 1 interventional study of controlled-ileocolonic-release nicotinamide (SAD/MAD/MD) and Immediate-release nicotinamide (SAD) in Safety Issues and Pharmacokinetic, sponsored by University Hospital Schleswig-Holstein. Completed at 1 site in Germany. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-08.

Sponsored by University Hospital Schleswig-Holstein · Phase 1, Interventional, and Other

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Dec 2020, registered Aug 2021).
Phase
Phase 1
Study type
Interventional
Enrollment
49
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Double-blind, randomised, placebo-controlled phase I trial with single-ascending and multiple-ascending dose 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.

Read the detailed description

Nicotinamide (NAM) has been implicated in the restoration and maintenance of a healthy gut microbiome. Conventional NAM formulations are designed for systemic NAM supplementation and therefore release NAM in the stomach and upper small intestine for maximum absorption. In contrast, the novel CICR-NAM tablets (controlled-ileocolonic-release nicotinamide) start releasing in the lower small intestine for topical delivery of NAM to the microbiota and the mucosa in the ileum and colon, also leading to a reduced systemic exposure. This clinical Phase I trial investigates the safety and tolerability of CICR-NAM in single- and multiple-ascending doses (1, 2 and 4 g). At the beginning of the trial, single-dose pharmacokinetics (PK) of 1 g of conventional immediate-release NAM and CICR-NAM are compared. At the end of the trial, patients with inflammatory bowel diseases (IBD) receive a medium multiple dose (2 g for 4 weeks) to compare their exposure, PK and safety data with those of healthy subjects at the same dose level.

02

Conditions studied

  • Safety Issues
  • Pharmacokinetic

Keywords

  • Nicotinamide
  • Inflammatory Bowel Disease
03

In context

Inflammatory Bowel Diseases

1,460 studies on the registry are indexed under Inflammatory Bowel Diseases; 437 are open to participants now.

This study's enrollment of 49 is below the median of 70 across 770 interventional studies indexed under Inflammatory Bowel Diseases.

Browse Inflammatory Bowel Diseases studies →

Lead sponsor

University Hospital Schleswig-Holstein is the lead sponsor of 157 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Main inclusion and exclusion criteria

Inclusion criteria for the SAD and MAD parts with healthy subjects:

  1. Male and female subjects aged 18 to 75 years.
  2. Healthy subjects without relevant medical conditions.
  3. Ability to understand and comply with the protocol.
  4. Signed written Informed Consent.
  5. A BMI of 18.5 to 29.99 kg/m².
  6. Non-smoker or light smoker (average of \<7 cigarettes per week) and no history of longterm, heavy smoking (>10 pack-years).

Inclusion criteria

Inclusion criteria for the MD-IBD part:

  1. Male and female patients with IBD and 18 to 75 years of age.
  2. Ability to understand and comply with the protocol.
  3. Signed written Informed Consent.
  4. Documented diagnosis of relapsing ileal, ileocolonic or colonic Crohn disease or relapsing ulcerative colitis.
  5. Concomitant therapy (background medication) for inflammatory bowel disease: none or stable 8 weeks before baseline.
  6. No signs of malignancy.

Exclusion criteria for the SAD and MAD part with healthy subjects:

  1. Pre-existing relevant medical conditions.
  2. Clinically relevant abnormal findings in medical history or screening assessments.
  3. Participation in a clinical study.
  4. Use of any prescribed or over-the-counter medication, food supplements or herbal preparations.
  5. Use of antibiotics (systemic or gut-acting [non-absorbed]).
  6. Pregnant or breastfeeding women or women of childbearing potential and male participants with female partners of childbearing age not using highly effective contraception till at least 1 month after last dosing of investigational medicinal product (IMP).
  7. Legal incapacity.
  8. Indications that the patient may be unable to comply with the study procedures, e.g. language barriers precluding adequate understanding or cooperation

Exclusion criteria

Exclusion criteria for the MD-IBD part:

  1. Diagnosis of indeterminate colitis, microscopic colitis, ischaemic colitis, infectious colitis, radiation colitis or diverticular disease (except for diverticles accompanying CD).
  2. Current or past diagnosis of complex fistulae or intra-abdominal or peritoneal abscesses.
  3. Strictures with obstructive symptoms.
  4. Pregnant or breastfeeding women or women of childbearing potential and male participants with female partners of childbearing age not using highly effective contraception till at least 1 month after last dosing of investigational medicinal product (IMP).
  5. Legal incapacity.
  6. Indications that the patient may be unable to comply with the study procedures, e.g. language barriers precluding adequate understanding or cooperation
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Investigator)
Enrollment
49 participants (actual)

Study arms

  • Experimental
    healthy subjects

    healthy subjects (single-ascending and multiple-ascending doses)

    Drug: controlled-ileocolonic-release nicotinamide (SAD/MAD/MD) · Drug: Immediate-release nicotinamide (SAD) · Drug: Placebo controlled-ileocolonic-release nicotinamide (SAD/MAD) · Drug: Placebo Immediate-release nicotinamide (SAD)

  • Experimental
    IBD-patients

    inflammatory bowel disease patients (multiple dose)

    Drug: controlled-ileocolonic-release nicotinamide (SAD/MAD/MD)

Interventions

  • Drugcontrolled-ileocolonic-release nicotinamide (SAD/MAD/MD)

    single- and multiple-ascending dose (SAD/MAD) or multiple dose (MD)

    Also known as: CICR-NAM (SAD/MAD/MD)

  • DrugImmediate-release nicotinamide (SAD)

    single-ascending dose (SAD)

    Also known as: ImR-NAM (SAD)

  • DrugPlacebo controlled-ileocolonic-release nicotinamide (SAD/MAD)

    single- and multiple-ascending dose (SAD/MAD)

    Also known as: no active substance

  • DrugPlacebo Immediate-release nicotinamide (SAD)

    single-ascending dose (SAD)

    Also known as: no active substance

06

What researchers measure

Primary outcomes

  1. Treatment-Emergent Adverse Events [Safety and Tolerability]

    Adverse Events (AEs) during treatment period

    Time frame: up to 60 days

  2. Treatment-Emergent Serious Adverse Events [Safety and Tolerability]

    Serious Adverse Events (SAEs) during treatment period

    Time frame: up to 60 days

  3. Haemoglobin

    Haemoglobin (Hb) in %

    Time frame: up to 60 days

  4. White blood cells

    White blood cell (WBC) count as x10\^9/l

    Time frame: up to 60 days

  5. Blood creatinine

    Blood Creatinine in mmol/L

    Time frame: up to 60 days

  6. Blood urea

    Urea in mmol/L

    Time frame: up to 60 days

  7. Blood uric acid

    Uric acid in mmol/L

    Time frame: up to 60 days

  8. Glomerular filtration rate

    Glomerular filtration rate (GFR, automatically calculated by the laboratory based on creatinine values) GFR in ml/min/1.73m2

    Time frame: up to 60 days

  9. Blood ALT

    Alanine transaminase (ALT) in U/l

    Time frame: up to 60 days

  10. Blood AST

    Aspartate transaminase (AST) in U/l

    Time frame: up to 60 days

  11. Blood GGT

    Gamma glutamyl transferase (GGT) in U/l

    Time frame: up to 60 days

07

Study locations

1 site
  • University Medical Center Schleswig-Holstein
    Kiel, Germany
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05258474
Lead sponsor
University Hospital Schleswig-Holstein
Responsible party
Sponsor
First posted
Feb 28, 2022
Start date
Dec 4, 2020
Primary completion
Mar 30, 2022
Completion
Mar 30, 2022
Last update
Nov 8, 2022

Study contacts

Susanna Nikolaus, Prof. Dr.
principal investigator · University Medical Center Schleswig-Holstein, Campus Kiel

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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