NCT03913000

A Study to Evaluate ID-085 in People With Mild, Moderate, and Severe Kidney Disease

Open-label, Phase 1 Study to Investigate the Effects of Mild, Moderate, and Severe Renal Function Impairment on the Pharmacokinetics, Safety, and Tolerability of a Single Dose of ID-085

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Idorsia Pharmaceuticals Ltd. · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to evaluate the pharmacokinetics (PK), tolerabilty and safety of a single dose of ID-085 in subjects with mild, moderate, and severe renal function impairment compared to healthy subjects

Conditions

• Renal Impairment

Interventions

Type	Name	Description
DRUG	ID-085	Hard capsules for oral administration formulated at a strength of 200 mg

Timeline

• Start date: 2019-04-29
• Primary completion: 2019-08-22
• Completion: 2019-08-22
• First posted: 2019-04-12
• Last updated: 2019-11-22

Locations

1 site across 1 country: Germany