Safety, Tolerability and Pharmacokinetics of Oral Doses of RP3128 of Rhizen Pharmaceuticals

Phase 1/2 Terminated 57 enrolled Rhizen Pharmaceuticals SA

RandomizedCrossoverDouble-blindTreatment

Summary

RP3128 is a calcium release activated calcium (CRAC) channel modulator. The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of single and multiple ascending dose(s) of RP3128 in healthy volunteers and to evaluate the effect on late phase asthmatic response to allergen challenge in patients with mild asthma.

Timeline

Start: 2016-11-03
Primary completion: 2018-02
Completion: 2018-02

Outcome

Outcome not reported

Stopped (Enrollment): “Significant recruitment delay in POC part”

Publications

Barde PJ, Viswanadha S, Veeraraghavan S, Vakkalanka SV, Nair A. A first-in-human study to evaluate the safety, tolerability and pharmacokinetics of RP3128, an oral calcium release-activated calcium (CRAC) channel modulator in healthy volunteers. J Clin Pharm Ther. 2021 Jun;46(3):677-687. doi: 10.1111/jcpt.13322. Epub 2020 Dec 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	RP3128	Unknown	25 mg	Oral
Subject	RP3128	Unknown	50 mg	Oral
Subject	RP3128	Unknown	100 mg	Oral
Subject	RP3128	Unknown	200 mg	Oral
Subject	RP3128	Unknown	400 mg	Oral