Back to results

DS2330b Alone and With Sevelamer in Patients on Chronic Hemodialysis

Primary Purpose

Hyperphosphatemia

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

DS-2330b PIB

Placebo

Sevelamer

DS-2330b Tablet

About this trial

This is an interventional treatment trial for Hyperphosphatemia focused on measuring Chronic hemodialysis, Investigational drug

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

DaVita Clinical Research
Orlando Clinical Research Center
DaVita Clinical Research
Prism Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Part A: DS-2330b PIB, then Tablet

Part A: DS-2330b Tablet, then PIB

Part B: Placebo

Part B: DS-2330b PIB

Part B: DS-2330b PIB + Sevelamer

Part B: Placebo + Sevelamer

Part C: DS-2330b Tablet + Sevelamer

Arm Description

On a non-dialysis day, participants are given a single 250 mg dose of DS-2330b PIB [Treatment A1] right after breakfast. At least 3 days will be allowed to let the first dose wash out. Then on a non-dialysis day the participants are given a single 250 mg dose of DS-2330b in tablet form [Treatment A2] right after breakfast.

On a non-dialysis day, participants are given a single 250 mg dose of DS-2330b in tablet form [Treatment A2] right after breakfast. At least 3 days will be allowed to let the first dose wash out. Then on a non-dialysis day the participants are given a single 250 mg dose of DS-2330b PIB [Treatment A1] right after breakfast.

Participants are given placebo three times daily [Treatment B1]

Participants are given 400 mg of DS-2330b PIB three times daily [Treatment B2]

Participants are given 400 mg of DS-2330b PIB along with 1.6 grams of sevelamer three times daily [Treatment B3]

Participants are given placebo along with 1.6 grams of sevelamer three times daily [Treatment B4]

Participants are given one 250 mg dose of DS-2330b in tablet form along with 1.6 grams of sevelamer three times daily [Treatment C]

Outcomes

Primary Outcome Measures

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

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

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

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

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

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

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

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

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

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

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.

Secondary Outcome Measures

Parts B and C: Cmax of DS-2330a

Parts B and C: Tmax of DS-2330a

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

Parts B and C: AUCinf for DS-2330a

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)

Part B: Dialysis clearance of DS-2330a

Full Information

NCT ID

NCT03305471

First Posted

October 4, 2017

Last Updated

March 21, 2019

Sponsor

Daiichi Sankyo, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03305471

Brief Title

DS2330b Alone and With Sevelamer in Patients on Chronic Hemodialysis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

August 17, 2017 (Actual)

Primary Completion Date

January 3, 2019 (Actual)

Study Completion Date

January 3, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Daiichi Sankyo, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperphosphatemia

Keywords

Chronic hemodialysis, Investigational drug

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Model Description

Part A has a 2-period, open-label, randomized, 2-way crossover design with a single dose of Treatments A1 and A2 Part B participants are randomized with a 2:3:3:3 ratio to Treatment B1, B2, B3, and B4, respectively, using a double-blind, repeated dose, parallel design Part C is an optional, single-arm, open label, repeated dose design

Masking

ParticipantInvestigator

Masking Description

Masking description is for Part B only - Parts A and C are Open Label, so have no masking

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part A: DS-2330b PIB, then Tablet

Arm Type

Experimental

Arm Description

Arm Title

Part A: DS-2330b Tablet, then PIB

Arm Type

Experimental

Arm Description

Arm Title

Part B: Placebo

Arm Type

Placebo Comparator

Arm Description

Participants are given placebo three times daily [Treatment B1]

Arm Title

Part B: DS-2330b PIB

Arm Type

Experimental

Arm Description

Participants are given 400 mg of DS-2330b PIB three times daily [Treatment B2]

Arm Title

Part B: DS-2330b PIB + Sevelamer

Arm Type

Experimental

Arm Description

Participants are given 400 mg of DS-2330b PIB along with 1.6 grams of sevelamer three times daily [Treatment B3]

Arm Title

Part B: Placebo + Sevelamer

Arm Type

Experimental

Arm Description

Participants are given placebo along with 1.6 grams of sevelamer three times daily [Treatment B4]

Arm Title

Part C: DS-2330b Tablet + Sevelamer

Arm Type

Experimental

Arm Description

Participants are given one 250 mg dose of DS-2330b in tablet form along with 1.6 grams of sevelamer three times daily [Treatment C]

Intervention Type

Drug

Intervention Name(s)

DS-2330b PIB

Intervention Description

DS-2330b as powder in bottle with stock solution (PIB)

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo matching stock solution in bottle

Intervention Type

Drug

Intervention Name(s)

Sevelamer

Other Intervention Name(s)

Sevelamer carbonate

Intervention Description

Sevelamer is a phosphate binder. It is used to decrease serum phosphate (Pi) level in people with chronic kidney disease who are on dialysis.

Intervention Type

Drug

Intervention Name(s)

DS-2330b Tablet

Intervention Description

DS-2330b as tablet formulation

Primary Outcome Measure Information:

Title

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

Time Frame

Period 1, Pre-dose to 48 hours post-dose

Title

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

Time Frame

Period 2, Pre-dose to 48 hours post-dose

Title

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

Time Frame

Period 1, Pre-dose to 48 hours post-dose

Title

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

Time Frame

Period 2, Pre-dose to 48 hours post-dose

Title

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

Title

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

Title

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

Description

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

Time Frame

Period 1, Pre-dose to 48 hours post-dose

Title

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

Description

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

Time Frame

Period 2, Pre-dose to 48 hours post-dose

Title

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

Time Frame

within 15 days

Title

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

Description

Time Frame

through trial completion (about 15 months)

Secondary Outcome Measure Information:

Title

Parts B and C: Cmax of DS-2330a

Time Frame

within 24 hours on Day 1

Title

Parts B and C: Cmax of DS-2330a

Time Frame

within 24 hours on Day 13

Title

Parts B and C: Tmax of DS-2330a

Time Frame

within 24 hours, Day 1

Title

Parts B and C: Tmax of DS-2330a

Time Frame

within 24 hours, Day 13

Title

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

Time Frame

Day 1

Title

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

Time Frame

Day 13

Title

Parts B and C: AUCinf for DS-2330a

Time Frame

Day 1

Title

Parts B and C: AUCinf for DS-2330a

Time Frame

Day 13

Title

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

Description

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

Time Frame

within 11 days

Title

Part B: Dialysis clearance of DS-2330a

Time Frame

on Day 11

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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: Has protocol-specified acceptable serum Pi levels at Screening and in serum Pi after up to 3 weeks of washout from all Pi binders 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: safety of the participant or their children safety of study staff analysis of study results For Parts B and C only: Is not able to take sevelamer carbonate Has had partial or total parathyroidectomy within the last six months

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Global Clinical Leader

Organizational Affiliation

Daiichi Sankyo, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

DaVita Clinical Research

City

Lakewood

State/Province

Colorado

ZIP/Postal Code

80228

Country

United States

Facility Name

Orlando Clinical Research Center

City

Orlando

State/Province

Florida

ZIP/Postal Code

32809

Country

United States

Facility Name

DaVita Clinical Research

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55404

Country

United States

Facility Name

Prism Clinical Research

City

Saint Paul

State/Province

Minnesota

ZIP/Postal Code

55114

Country

United States

12. IPD Sharing Statement

Learn more about this trial

DS2330b Alone and With Sevelamer in Patients on Chronic Hemodialysis

We'll reach out to this number within 24 hrs