Safety, Tolerability, and Pharmacodynamics of RDX5791 in Healthy Volunteers

Phase 1 Completed 105 enrolled Ardelyx

RandomizedSingle-groupQuadruple-blindBasic science

Summary

A Phase 1, single-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerabiltiy, and pharmacodynamics of different multiple dose regimens of RDX5791 in healthy volunteers.

Timeline

Start: 2011-07
Primary completion: 2011-10
Completion: 2012-04

Publications

Rosenbaum DP, Yan A, Jacobs JW. Pharmacodynamics, Safety, and Tolerability of the NHE3 Inhibitor Tenapanor: Two Trials in Healthy Volunteers. Clin Drug Investig. 2018 Apr;38(4):341-351. doi: 10.1007/s40261-017-0614-0.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tenapanor	Small molecule	15 mg	Oral
Subject	Tenapanor	Small molecule	30 mg	Oral
Subject	Tenapanor	Small molecule	45 mg	Oral
Subject	Tenapanor	Small molecule	60 mg	Oral

Indications

No indication recorded.