CompletedPhase 1

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

Germany49 participantsStarted 2020-12-04

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. 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).
✕. Male and female patients with IBD and 18 to 75 years of age.
✕. Ability to understand and comply with the protocol.

What they're measuring

Treatment-Emergent Adverse Events [Safety and Tolerability]

Timeframe: up to 60 days

Treatment-Emergent Serious Adverse Events [Safety and Tolerability]

Timeframe: up to 60 days

Haemoglobin

Timeframe: up to 60 days

White blood cells

Timeframe: up to 60 days

Blood creatinine

Timeframe: up to 60 days

Blood urea

Timeframe: up to 60 days

Blood uric acid

Timeframe: up to 60 days

Glomerular filtration rate

Timeframe: up to 60 days

Blood ALT

Timeframe: up to 60 days

Trial details

NCT IDNCT05258474

SponsorUniversity Hospital Schleswig-Holstein

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-03-30

View on ClinicalTrials.gov More Safety Issues trials