NCT02819687

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

A Phase 1, 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 Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Ardelyx · Industry
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

In the single-ascending dose (SAD), 5 separate cohorts received RDX5791 at various doses once po fasting. Each cohort of 8 subjects (6 RDX5791, 2 placebo) received a diet standardized fro Na+ content wile in the clinical pharmacology unit (CPU). The PK data from the 50-mg dose and the safety data from the 150-mg dose of the SAD study were evaluated prior to proceeding with the multiple-ascending dose (MAD) phase. Doses of RDX5791 are 3, 10, 30, and 100 mg administered once daily po fasting. Four cohorts of 10 subjects each (8 RDX5791, 2 placebo) received a diet standardized for Na+ content while in the CPU. Safety assessments including clinical assessment and vital signs, clinical laboratory evaluations, ECGs, and AE monitoring were performed at regular intervals. Plasma was collected at regular intervals for PK analysis. The PD assessment included stool frequency and consistency, as well as changes in urinary Na+ excretion. All bowel movements were collected and analyzed for Na+ content outside this study protocol.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	RDX5791
DRUG	Placebo

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-03-01
• Completion: 2011-08-01
• First posted: 2016-06-30
• Last updated: 2016-06-30