Evaluation of Safety and Pharmacokinetics of Oral Controlled-ileal-release Nicotinic Acid (CIR-NA) Compared to Immediate-release Nicotinic Acid and Placebo in Healthy Subjects and Subjects With Prediabetes

NCT06378125 | Completed Phase 1 DMC

• 1 other identifier: CIR-NA I
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

A double-blind, randomised, placebo-controlled, single-ascending and multiple-ascending dose trial to evaluate the safety and pharmacokinetics of oral controlled-ileal-release nicotinic acid (CIR-NA) compared to immediate-release nicotinic acid and placebo in healthy subjects and subjects with prediabetes.

Conditions

Safety Issues; Pharmacokinetic

Keywords

Nicotinic Acid; Prediabetes

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 healthy subjects

EXPERIMENTAL

single-ascending and multipleascending doses (SAD/MAD)

Drug: controlled-ileal-release nicotinic acid (SAD/ MAD/MD) single- and multiple-ascending dose (SAD/MAD) or multiple dose (MD); Drug: immediate-release nicotinic acid (SAD); Drug: Placebo controlled-ileal-release nicotinic acid (SAD/MAD); Drug: Placebo immediate-release nicotinic acid (SAD)

subjects with prediabetes

EXPERIMENTAL

multiple dose (MD)

Drug: controlled-ileal-release nicotinic acid (SAD/ MAD/MD) single- and multiple-ascending dose (SAD/MAD) or multiple dose (MD)

Interventions

controlled-ileal-release nicotinic acid (SAD/ MAD/MD) single- and multiple-ascending dose (SAD/MAD) or multiple dose (MD) DRUG

A double-blind, randomised, placebo-controlled, single-ascending and multiple-ascending dose trial to evaluate the safety and pharmacokinetics of oral controlled-ileal-release nicotinic acid (CIR-NA) compared to immediate-release nicotinic acid and placebo in healthy subjects and subjects with prediabetes.

Also known as: CIR-NA (SAD/MAD/MD)

healthy subjects healthy subjects; subjects with prediabetes

immediate-release nicotinic acid (SAD) DRUG

A double-blind, randomised, placebo-controlled, single-ascending and multiple-ascending dose trial to evaluate the safety and pharmacokinetics of oral controlled-ileal-release nicotinic acid (CIR-NA) compared to immediate-release nicotinic acid and placebo in healthy subjects and subjects with prediabetes.

Also known as: ImR-NA (SAD)

healthy subjects healthy subjects

Placebo controlled-ileal-release nicotinic acid (SAD/MAD) DRUG

A double-blind, randomised, placebo-controlled, single-ascending and multiple-ascending dose trial to evaluate the safety and pharmacokinetics of oral controlled-ileal-release nicotinic acid (CIR-NA) compared to immediate-release nicotinic acid and placebo in healthy subjects and subjects with prediabetes.

Also known as: no active substance (SAD/MAD)

healthy subjects healthy subjects

Placebo immediate-release nicotinic acid (SAD) DRUG

A double-blind, randomised, placebo-controlled, single-ascending and multiple-ascending dose trial to evaluate the safety and pharmacokinetics of oral controlled-ileal-release nicotinic acid (CIR-NA) compared to immediate-release nicotinic acid and placebo in healthy subjects and subjects with prediabetes.

Also known as: no active substance (SAD)

healthy subjects healthy subjects

Eligibility Criteria

• Age: 18 Years - 65 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 65 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 subjects aged 18 to 65 years.
• Previously diagnosed prediabetes with confirmation via the HbA1c level (5.7 to \< 6.5%) at the screening visit.
• Subjects without relevant medical conditions and without clinically significant impairment of renal or hepatic function.
• Ability to understand and comply with the protocol.
• Signed written Informed Consent.
• A body mass index of 25 to 40 kg/m², both inclusive .
• Non-smoker or light smoker (average of \<7 cigarettes per week) and no history of longterm, heavy smoking (\>10 pack-years).
• Pre-existing relevant medical conditions.
• Clinically relevant abnormal findings in medical history or screening assessments.

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead

Study Sites (1)

University Medical Center Schleswig-Holstein, Campus Kiel

Kiel, Schleswig-Holstein, 24105, Germany

Location

MeSH Terms

Conditions

Prediabetic State

Interventions

Sagittal Abdominal Diameter; Single Person

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Body Size; Body Weights and Measures; Body Constitution; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Anthropometry; Investigative Techniques; Physiological Phenomena; Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors

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
• Masking Details: Double (Participant, Investigator)
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 22, 2024
• Study Start: December 19, 2022
• Primary Completion: November 12, 2024
• Study Completion: November 12, 2024
• Last Updated: November 27, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)