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

PHASE1CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

December 19, 2022

Primary Completion Date

November 12, 2024

Study Completion Date

November 12, 2024

Conditions
Safety IssuesPharmacokinetic
Interventions
DRUG

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

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.

DRUG

immediate-release nicotinic acid (SAD)

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.

DRUG

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

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.

DRUG

Placebo immediate-release nicotinic acid (SAD)

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.

Trial Locations (1)

24105

University Medical Center Schleswig-Holstein, Campus Kiel, Kiel

All Listed Sponsors
lead

University Hospital Schleswig-Holstein

OTHER