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

NCT05258474 | Completed Phase 1 DMC

• 3 other identifiers: CICR-NAM2020-002815-23DRKS00023384
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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 (CICR-NAM) compared to immediate-release nicotinamide and placebo in healthy subjects and in patients with inflammatory bowel diseases.

Conditions

Safety Issues; Pharmacokinetic

Keywords

Nicotinamide; Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (11)

• Treatment-Emergent Adverse Events [Safety and Tolerability]

  Adverse Events (AEs) during treatment period

  up to 60 days

• Treatment-Emergent Serious Adverse Events [Safety and Tolerability]

  Serious Adverse Events (SAEs) during treatment period

  up to 60 days

• Haemoglobin

  Haemoglobin (Hb) in %

  up to 60 days

• White blood cells

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

  up to 60 days

• Blood creatinine

  Blood Creatinine in mmol/L

  up to 60 days

• Blood urea

  Urea in mmol/L

  up to 60 days

• Blood uric acid

  Uric acid in mmol/L

  up to 60 days

• Glomerular filtration rate

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

  up to 60 days

• Blood ALT

  Alanine transaminase (ALT) in U/l

  up to 60 days

• Blood AST

  Aspartate transaminase (AST) in U/l

  up to 60 days

• Blood GGT

  Gamma glutamyl transferase (GGT) in U/l

  up to 60 days

Study Arms (2)

healthy subjects

EXPERIMENTAL

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)

IBD-patients

EXPERIMENTAL

inflammatory bowel disease patients (multiple dose)

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

Interventions

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

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

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

IBD-patients; healthy subjects

Immediate-release nicotinamide (SAD) DRUG

single-ascending dose (SAD)

Also known as: ImR-NAM (SAD)

healthy subjects

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

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

Also known as: no active substance

healthy subjects

Placebo Immediate-release nicotinamide (SAD) DRUG

single-ascending dose (SAD)

Also known as: no active substance

healthy subjects

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• 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.
• Pre-existing relevant medical conditions.
• Clinically relevant abnormal findings in medical history or screening assessments.
• Participation in a clinical study.

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead

Study Sites (1)

University Medical Center Schleswig-Holstein

Kiel, Germany

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Sagittal Abdominal Diameter

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Body Size; Body Weights and Measures; Body Constitution; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Anthropometry; Investigative Techniques; Physiological Phenomena

Study Officials

• Susanna Nikolaus, Prof. Dr.

  University Medical Center Schleswig-Holstein, Campus Kiel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: February 28, 2022
• Study Start: December 4, 2020
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)