A Single and Multiple Ascending and Food Effect Study of RP7214, a DHODH Inhibitor in Healthy Adult Subjects

Phase 1 Completed 42 enrolled Rhizen Pharmaceuticals SA

RandomizedParallel-groupDouble-blindTreatment

Summary

This is a randomized, double-blind study to evaluate the safety, tolerability and PK of single and multiple ascending oral doses of RP7214. The relative bioavailability in fed and fasting conditions will also be evaluated for RP7214. The study comprises three parts; Part 1: Single ascending dose, Part 2: Multiple ascending dose and Part 3: Food effect.

Timeline

Start: 2020-12-29
Primary completion: 2021-07-17
Completion: 2021-07-19

Publications

Nair A, Barde PJ, Routhu KV, Viswanadha S, Veeraraghavan S, Pak S, Peterson JA, Vakkalanka S. A first in man study to evaluate the safety, pharmacokinetics and pharmacodynamics of RP7214, a dihydroorotate dehydrogenase inhibitor in healthy subjects. Br J Clin Pharmacol. 2023 Mar;89(3):1127-1138. doi: 10.1111/bcp.15562. Epub 2022 Nov 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	RP7214	Unknown	100 mg	Oral
Subject	RP7214	Unknown	200 mg	Oral
Subject	RP7214	Unknown	400 mg	Oral

Indications

No indication recorded.