Status:
COMPLETED
Safety and Pharmacokinetics of Oral Controlled-ileocolonic-release Nicotinamide (CICR-NAM)
Lead Sponsor:
University Hospital Schleswig-Holstein
Conditions:
Safety Issues
Pharmacokinetic
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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...
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...
Eligibility Criteria
Inclusion
- Main inclusion and exclusion criteria
- Inclusion criteria for the SAD and MAD parts with healthy subjects:
- Male and female subjects aged 18 to 75 years.
- Healthy subjects without relevant medical conditions.
- Ability to understand and comply with the protocol.
- Signed written Informed Consent.
- A BMI of 18.5 to 29.99 kg/m².
- Non-smoker or light smoker (average of \<7 cigarettes per week) and no history of longterm, heavy smoking (\>10 pack-years).
- Inclusion criteria for the MD-IBD part:
- Male and female patients with IBD and 18 to 75 years of age.
- Ability to understand and comply with the protocol.
- Signed written Informed Consent.
- Documented diagnosis of relapsing ileal, ileocolonic or colonic Crohn disease or relapsing ulcerative colitis.
- Concomitant therapy (background medication) for inflammatory bowel disease: none or stable 8 weeks before baseline.
- No signs of malignancy.
- Exclusion criteria for the SAD and MAD part with healthy subjects:
- Pre-existing relevant medical conditions.
- Clinically relevant abnormal findings in medical history or screening assessments.
- Participation in a clinical study.
- Use of any prescribed or over-the-counter medication, food supplements or herbal preparations.
- Use of antibiotics (systemic or gut-acting \[non-absorbed\]).
- 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).
- Legal incapacity.
- Indications that the patient may be unable to comply with the study procedures, e.g. language barriers precluding adequate understanding or cooperation
- Exclusion criteria for the MD-IBD part:
- Diagnosis of indeterminate colitis, microscopic colitis, ischaemic colitis, infectious colitis, radiation colitis or diverticular disease (except for diverticles accompanying CD).
- Current or past diagnosis of complex fistulae or intra-abdominal or peritoneal abscesses.
- Strictures with obstructive symptoms.
- 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).
- Legal incapacity.
- Indications that the patient may be unable to comply with the study procedures, e.g. language barriers precluding adequate understanding or cooperation
Exclusion
Key Trial Info
Start Date :
December 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2022
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT05258474
Start Date
December 4 2020
End Date
March 30 2022
Last Update
November 8 2022
Active Locations (1)
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1
University Medical Center Schleswig-Holstein
Kiel, Germany