DS2330b Alone and With Sevelamer in Patients on Chronic Hemodialysis

Hyperphosphatemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03305471
• Other study ID #: DS2330-A-U103
• Status: Completed
• Phase: Phase 1
• Start date: August 17, 2017
• Est. completion date: January 3, 2019

Study information

• Verified date: March 2019
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 3, 2019
• Est. primary completion date: January 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperphosphatemia

Intervention

Drug:
• DS-2330b PIB
DS-2330b as powder in bottle with stock solution (PIB)
• Placebo
Placebo matching stock solution in bottle
• 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.
• DS-2330b Tablet
DS-2330b as tablet formulation

Locations

Country	Name	City	State
United States	DaVita Clinical Research	Lakewood	Colorado
United States	DaVita Clinical Research	Minneapolis	Minnesota
United States	Orlando Clinical Research Center	Orlando	Florida
United States	Prism Clinical Research	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part A, Period 1: Maximum concentration (Cmax) of DS-2330a		Period 1, Pre-dose to 48 hours post-dose
Primary	Part A, Period 2: Cmax of DS-2330a		Period 2, Pre-dose to 48 hours post-dose
Primary	Part A, Period 1: Time to maximum concentration (Tmax) of DS-2330a		Period 1, Pre-dose to 48 hours post-dose
Primary	Part A, Period 2: Tmax of DS-2330a		Period 2, Pre-dose to 48 hours post-dose
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Parts B and C: Serum phosphate (Pi) levels before hemodialysis		within 15 days
Primary	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)
Secondary	Parts B and C: Cmax of DS-2330a		within 24 hours on Day 1
Secondary	Parts B and C: Cmax of DS-2330a		within 24 hours on Day 13
Secondary	Parts B and C: Tmax of DS-2330a		within 24 hours, Day 1
Secondary	Parts B and C: Tmax of DS-2330a		within 24 hours, Day 13
Secondary	Parts B and C: AUC-24 for DS-2330a		Day 1
Secondary	Parts B and C: AUC-24 for DS-2330a		Day 13
Secondary	Parts B and C: AUCinf for DS-2330a		Day 1
Secondary	Parts B and C: AUCinf for DS-2330a		Day 13
Secondary	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
Secondary	Part B: Dialysis clearance of DS-2330a		on Day 11