DS2330b Alone and With Sevelamer in Patients on Chronic Hemodialysis

• Status: Completed
• Trial end date: 2019-01-03
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo, Inc.
• Treatments: Sevelamer

Criteria

Inclusion Criteria:

• Has a body mass index (BMI) of 18 kg/m^2 to 40 kg/m^2 (inclusive)

• Is on prescribed maintenance hemodialysis (three times a week) for at least 3 months before Screening with adequacy demonstrated by a dialysis clearance within 3 months before the first dose of the investigational medicinal product

• Has permanent vascular access [arteriovenous (A-V) fistula or graft]

• Is willing to comply with protocol-specified methods for family planning

• For Parts B and C only:

1. Has protocol-specified acceptable serum Pi levels at Screening and in serum Pi after up to 3 weeks of washout from all Pi binders

2. Has protocol-specified acceptable serum Ca^2+ level and intact parathyroid hormone (iPTH) level at screening

Exclusion Criteria:

• Is employed by the clinic or the sponsor

• Has family relationship with another study participant

• Has any history, current condition, or drug use that per protocol or in the opinion of the investigator might compromise:

1. safety of the participant or their children

2. safety of study staff

3. analysis of study results

• For Parts B and C only:

1. Is not able to take sevelamer carbonate

2. Has had partial or total parathyroidectomy within the last six months