DS2330b Alone and With Sevelamer in Patients on Chronic Hemodialysis

Daiichi Sankyo40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hyperphosphatemia

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (4)

DaVita Clinical Research

Lakewood, Colorado, United States

Orlando Clinical Research Center

Orlando, Florida, United States

DaVita Clinical Research

Minneapolis, Minnesota, United States

Prism Clinical Research

Saint Paul, Minnesota, United States

Outcomes

Primary Outcomes

Part A, Period 1: Maximum concentration (Cmax) of DS-2330a

Time frame: Period 1, Pre-dose to 48 hours post-dose

Part A, Period 2: Cmax of DS-2330a

Time frame: Period 2, Pre-dose to 48 hours post-dose

Part A, Period 1: Time to maximum concentration (Tmax) of DS-2330a

Time frame: Period 1, Pre-dose to 48 hours post-dose

Part A, Period 2: Tmax of DS-2330a

Time frame: Period 2, Pre-dose to 48 hours post-dose

Part A, Period 1: Area under the drug concentration curve (AUC) for DS-2330a over 24 hours (AUC-24)

Time frame: Period 1, Pre-dose to 24 hours post-dose

Part A, Period 2: AUC for DS-2330a for DS-2330a over 24 hours (AUC-24)

Time frame: Period 2, Pre-dose to 24 hours post-dose

Part A, Period 1: AUC at the last observable concentration (AUClast) and to infinity (AUCinf) for DS-2330a

Categories (with the same unit of measure ng\*hr/mL): AUClast, AUCinf

Time frame: Period 1, Pre-dose to 48 hours post-dose

Part A, Period 2: AUClast and AUCinf for DS-2330a

Categories (with the same unit of measure ng\*hr/mL): AUClast, AUCinf

Time frame: Period 2, Pre-dose to 48 hours post-dose

Parts B and C: Serum phosphate (Pi) levels before hemodialysis

Time frame: within 15 days

All Parts: Number of trial participants with treatment-emergent adverse events (TEAEs)

TEAEs are adverse events (side effects) associated with taking an investigational product, whether or not they were caused by the investigational product. Clinically significant changes in physical exam findings, vital signs, electrocardiograms, clinical lab tests and thyroid function are recorded as TEAEs.

Time frame: through trial completion (about 15 months)

Secondary Outcomes

Parts B and C: Cmax of DS-2330a

Time frame: within 24 hours on Day 1

Parts B and C: Cmax of DS-2330a

Time frame: within 24 hours on Day 13

Parts B and C: Tmax of DS-2330a

Time frame: within 24 hours, Day 1

Parts B and C: Tmax of DS-2330a

Time frame: within 24 hours, Day 13

Parts B and C: AUC-24 for DS-2330a

Time frame: Day 1

Parts B and C: AUC-24 for DS-2330a

Time frame: Day 13

Parts B and C: AUCinf for DS-2330a

Time frame: Day 1

Parts B and C: AUCinf for DS-2330a

Time frame: Day 13

Parts B and C: Minimum concentration (Ctrough) of DS-2330a

Trough blood levels for DS-2330a will be collected before the morning dose (prior to breakfast)

Time frame: within 11 days

Part B: Dialysis clearance of DS-2330a

Time frame: on Day 11