drugset / Trial / NCT06378125
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
RandomizedSequentialDouble-blindOther
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.
Timeline
- Start
- 2022-12-19
- Primary completion
- 2024-11-12
- Completion
- 2024-11-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Niacin | Small molecule | 100 mg | Oral |
| Subject | Niacin | Small molecule | 200 mg | Oral |
| Subject | Niacin | Small molecule | 500 mg | Oral |
| Subject | Niacin | Small molecule | 1000 mg | Oral |
| Subject | Niacin | Small molecule | 2000 mg | Oral |
| Subject | Niacin | Small molecule | — | — |
Indications
No indication recorded.