drugset / Trial / NCT05258474
Safety and Pharmacokinetics of Oral Controlled-ileocolonic-release Nicotinamide (CICR-NAM)
RandomizedSequentialDouble-blindOther
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.
Timeline
- Start
- 2020-12-04
- Primary completion
- 2022-03-30
- Completion
- 2022-03-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nicotinamide | Other / unclassified | 1 g | Oral |
| Subject | Nicotinamide | Other / unclassified | 2 g | Oral |
| Subject | Nicotinamide | Other / unclassified | 4 g | Oral |
Indications
No indication recorded.