NCT03305471

DS2330b Alone and With Sevelamer in Patients on Chronic Hemodialysis

A Phase 1b Study, to Assess the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Repeated Doses of DS-2330b Alone and When Co-administered With Sevelamer in Patients on Chronic Hemodialysis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This three-part study will be performed with participants on chronic hemodialysis. * Part A will assess plasma pharmacokinetics of DS2330a (free form of DS2330b) after a single dose of powder in bottle (PIB) or tablet formulations of DS2330b * Part B will test the safety, tolerability, and effects on serum phosphate (Pi) of 14-day repeated oral doses of DS-2330b PIB when given alone and when given along with sevelamer carbonate three times a day * Part C is optional, and will test the effects on serum phosphate (Pi) of 14-day repeated oral doses of DS-2330b tablets when given with sevelamer carbonate After screening, participants should expect the study to last about 21 days for Part A, and 46 days for Parts B and C.

Conditions

• Hyperphosphatemia

Interventions

Type	Name	Description
DRUG	DS-2330b PIB	DS-2330b as powder in bottle with stock solution (PIB)
DRUG	Placebo	Placebo matching stock solution in bottle
DRUG	Sevelamer	Sevelamer is a phosphate binder. It is used to decrease serum phosphate (Pi) level in people with chronic kidney disease who are on dialysis.
DRUG	DS-2330b Tablet	DS-2330b as tablet formulation

Timeline

• Start date: 2017-08-17
• Primary completion: 2019-01-03
• Completion: 2019-01-03
• First posted: 2017-10-10
• Last updated: 2019-03-25

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study