A Phase 1 interventional study of DS-2330b PIB and Placebo in Hyperphosphatemia, sponsored by Daiichi Sankyo. Completed at 4 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-03-25.
Sponsored by Daiichi Sankyo · Phase 1, Interventional, and Treatment
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.
For Parts B and C only:
Exclusion Criteria:
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:
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.
Drug: DS-2330b PIB · Drug: DS-2330b Tablet
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.
Drug: DS-2330b PIB · Drug: DS-2330b Tablet
Participants are given placebo three times daily \[Treatment B1\]
Drug: Placebo
Participants are given 400 mg of DS-2330b PIB three times daily \[Treatment B2\]
Drug: DS-2330b PIB
Participants are given 400 mg of DS-2330b PIB along with 1.6 grams of sevelamer three times daily \[Treatment B3\]
Drug: DS-2330b PIB · Drug: Sevelamer
Participants are given placebo along with 1.6 grams of sevelamer three times daily \[Treatment B4\]
Drug: Placebo · Drug: Sevelamer
Participants are given one 250 mg dose of DS-2330b in tablet form along with 1.6 grams of sevelamer three times daily \[Treatment C\]
Drug: Sevelamer · Drug: DS-2330b Tablet
DS-2330b as powder in bottle with stock solution (PIB)
Placebo matching stock solution in bottle
Sevelamer is a phosphate binder. It is used to decrease serum phosphate (Pi) level in people with chronic kidney disease who are on dialysis.
Also known as: Sevelamer carbonate
DS-2330b as tablet formulation
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)
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
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Daiichi Sankyo