DS2330b Alone and With Sevelamer in Patients on Chronic Hemodialysis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-17

Study Completion Date

2019-01-03

Brief Summary

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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.

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Detailed Description

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Conditions

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Hyperphosphatemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

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

Study Groups

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Part A: DS-2330b PIB, then Tablet

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.

Group Type EXPERIMENTAL

DS-2330b PIB

Intervention Type DRUG

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

DS-2330b Tablet

Intervention Type DRUG

DS-2330b as tablet formulation

Part A: DS-2330b Tablet, then PIB

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.

Group Type EXPERIMENTAL

DS-2330b PIB

Intervention Type DRUG

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

DS-2330b Tablet

Intervention Type DRUG

DS-2330b as tablet formulation

Part B: Placebo

Participants are given placebo three times daily \[Treatment B1\]

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo matching stock solution in bottle

Part B: DS-2330b PIB

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

Group Type EXPERIMENTAL

DS-2330b PIB

Intervention Type DRUG

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

Part B: DS-2330b PIB + Sevelamer

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

Group Type EXPERIMENTAL

DS-2330b PIB

Intervention Type DRUG

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

Sevelamer

Intervention Type DRUG

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

Part B: Placebo + Sevelamer

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

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Placebo matching stock solution in bottle

Sevelamer

Intervention Type DRUG

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

Part C: DS-2330b Tablet + Sevelamer

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

Group Type EXPERIMENTAL

Sevelamer

Intervention Type DRUG

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

DS-2330b Tablet

Intervention Type DRUG

DS-2330b as tablet formulation

Interventions

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DS-2330b PIB

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

Intervention Type DRUG

Placebo

Placebo matching stock solution in bottle

Intervention Type 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.

Intervention Type DRUG

DS-2330b Tablet

DS-2330b as tablet formulation

Intervention Type DRUG

Other Intervention Names

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Sevelamer carbonate

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No