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This three-part study will be performed with participants on chronic hemodialysis.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: DS-2330b PIB, then Tablet | Experimental | 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. |
|
| Part A: DS-2330b Tablet, then PIB | Experimental | 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. |
|
| Part B: Placebo | Placebo Comparator | Participants are given placebo three times daily [Treatment B1] |
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| Part B: DS-2330b PIB | Experimental | Participants are given 400 mg of DS-2330b PIB three times daily [Treatment B2] |
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| Part B: DS-2330b PIB + Sevelamer | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DS-2330b PIB | Drug | DS-2330b as powder in bottle with stock solution (PIB) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A, Period 1: Maximum concentration (Cmax) of DS-2330a | Period 1, Pre-dose to 48 hours post-dose | |
| Part A, Period 2: Cmax of DS-2330a | Period 2, Pre-dose to 48 hours post-dose | |
| Part A, Period 1: Time to maximum concentration (Tmax) of DS-2330a | Period 1, Pre-dose to 48 hours post-dose | |
| Part A, Period 2: Tmax of DS-2330a | 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) | 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) | 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 | 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 | Period 2, Pre-dose to 48 hours post-dose |
| Parts B and C: Serum phosphate (Pi) levels before hemodialysis |
| Measure | Description | Time Frame |
|---|---|---|
| Parts B and C: Cmax of DS-2330a | within 24 hours on Day 1 | |
| Parts B and C: Cmax of DS-2330a | within 24 hours on Day 13 | |
| Parts B and C: Tmax of DS-2330a |
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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:
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:
For Parts B and C only:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Leader | Daiichi Sankyo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DaVita Clinical Research | Lakewood | Colorado | 80228 | United States | ||
| Orlando Clinical Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40576086 | Derived | Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4. |
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| ID | Term |
|---|---|
| D054559 | Hyperphosphatemia |
| ID | Term |
|---|---|
| D010760 | Phosphorus Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069603 | Sevelamer |
| ID | Term |
|---|---|
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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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
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Masking description is for Part B only - Parts A and C are Open Label, so have no masking
Participants are given 400 mg of DS-2330b PIB along with 1.6 grams of sevelamer three times daily [Treatment B3] |
|
| Part B: Placebo + Sevelamer | Experimental | Participants are given placebo along with 1.6 grams of sevelamer three times daily [Treatment B4] |
|
| Part C: DS-2330b Tablet + Sevelamer | Experimental | 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] |
|
| Placebo | Drug | Placebo matching stock solution in bottle |
|
| Sevelamer | 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. |
|
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| DS-2330b Tablet | Drug | DS-2330b as tablet formulation |
|
| 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. | through trial completion (about 15 months) |
| within 24 hours, Day 1 |
| Parts B and C: Tmax of DS-2330a | within 24 hours, Day 13 |
| Parts B and C: AUC-24 for DS-2330a | Day 1 |
| Parts B and C: AUC-24 for DS-2330a | Day 13 |
| Parts B and C: AUCinf for DS-2330a | Day 1 |
| Parts B and C: AUCinf for DS-2330a | 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) | within 11 days |
| Part B: Dialysis clearance of DS-2330a | on Day 11 |
| Orlando |
| Florida |
| 32809 |
| United States |
| DaVita Clinical Research | Minneapolis | Minnesota | 55404 | United States |
| Prism Clinical Research | Saint Paul | Minnesota | 55114 | United States |