Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RDX5791 in Healthy Volunteers

NCT02819687 ↗

Phase 1 Completed 80 enrolled Ardelyx

Non-randomizedSingle-groupQuadruple-blindBasic science

Summary

A Phase I, single-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single-and multiple-ascending doses of RDX5791 in healthy male and female subjects.

Timeline

Start: 2010-11
Primary completion: 2011-03
Completion: 2011-08

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	3 mg	Oral
Subject	Tenapanor	Small molecule	10 mg	Oral
Subject	Tenapanor	Small molecule	30 mg	Oral
Subject	Tenapanor	Small molecule	50 mg	Oral
Subject	Tenapanor	Small molecule	100 mg	Oral
Subject	Tenapanor	Small molecule	150 mg	Oral
Subject	Tenapanor	Small molecule	450 mg	Oral
Subject	Tenapanor	Small molecule	900 mg	Oral

Indications

No indication recorded.