DS2330b Alone and With Sevelamer in Patients on Chronic Hemodialysis
- Conditions
- Hyperphosphatemia
- Interventions
- Registration Number
- NCT03305471
- Lead Sponsor
- Daiichi Sankyo
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
-
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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part B: DS-2330b PIB + Sevelamer DS-2330b PIB Participants are given 400 mg of DS-2330b PIB along with 1.6 grams of sevelamer three times daily \[Treatment B3\] Part A: DS-2330b Tablet, then PIB DS-2330b 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. Part A: DS-2330b PIB, then Tablet DS-2330b PIB 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 PIB, then Tablet DS-2330b 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. Part A: DS-2330b Tablet, then PIB 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. Part B: Placebo Placebo Participants are given placebo three times daily \[Treatment B1\] Part B: DS-2330b PIB DS-2330b PIB Participants are given 400 mg of DS-2330b PIB three times daily \[Treatment B2\] Part B: Placebo + Sevelamer Placebo Participants are given placebo along with 1.6 grams of sevelamer three times daily \[Treatment B4\] Part C: DS-2330b Tablet + Sevelamer DS-2330b Tablet Participants are given one 250 mg dose of DS-2330b in tablet form along with 1.6 grams of sevelamer three times daily \[Treatment C\] Part B: DS-2330b PIB + Sevelamer Sevelamer 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 Sevelamer Participants are given placebo along with 1.6 grams of sevelamer three times daily \[Treatment B4\] Part C: DS-2330b Tablet + Sevelamer Sevelamer Participants are given one 250 mg dose of DS-2330b in tablet form along with 1.6 grams of sevelamer three times daily \[Treatment C\]
- Primary Outcome Measures
Name Time Method 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: Maximum concentration (Cmax) of DS-2330a Period 1, 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 All Parts: Number of trial participants with treatment-emergent adverse events (TEAEs) through trial completion (about 15 months) 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.
Part A, Period 2: Cmax of DS-2330a Period 2, Pre-dose to 48 hours post-dose Parts B and C: Serum phosphate (Pi) levels before hemodialysis within 15 days 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 Period 1, Pre-dose to 48 hours post-dose Categories (with the same unit of measure ng\*hr/mL): AUClast, AUCinf
Part A, Period 2: AUClast and AUCinf for DS-2330a Period 2, Pre-dose to 48 hours post-dose Categories (with the same unit of measure ng\*hr/mL): AUClast, AUCinf
- Secondary Outcome Measures
Name Time Method Parts B and C: Tmax of DS-2330a within 24 hours, Day 13 Parts B and C: AUCinf for DS-2330a Day 13 Parts B and C: Cmax of DS-2330a within 24 hours on Day 13 Parts B and C: AUC-24 for DS-2330a Day 13 Parts B and C: Minimum concentration (Ctrough) of DS-2330a within 11 days Trough blood levels for DS-2330a will be collected before the morning dose (prior to breakfast)
Part B: Dialysis clearance of DS-2330a on Day 11
Trial Locations
- Locations (3)
Orlando Clinical Research Center
🇺🇸Orlando, Florida, United States
DaVita Clinical Research
🇺🇸Minneapolis, Minnesota, United States
Prism Clinical Research
🇺🇸Saint Paul, Minnesota, United States