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

NCT05258474 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2022-11-08

No results posted yet for this 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.

Conditions

  • Safety Issues
  • Pharmacokinetic

Interventions

DRUG

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

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

DRUG

Immediate-release nicotinamide (SAD)

single-ascending dose (SAD)

DRUG

Placebo controlled-ileocolonic-release nicotinamide (SAD/MAD)

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

DRUG

Placebo Immediate-release nicotinamide (SAD)

single-ascending dose (SAD)

Sponsors & Collaborators

  • University Hospital Schleswig-Holstein

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-04
Primary Completion
2022-03-30
Completion
2022-03-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05258474 on ClinicalTrials.gov