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Completed

NCT Number: NCT03305471

DS2330b Alone and With Sevelamer in Patients on Chronic Hemodialysis

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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Key information

Conditions

Hyperphosphatemia Metabolic Diseases Nutritional and Metabolic Diseases Phosphorus Metabolism Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

DaVita Clinical Research, Lakewood, Colorado, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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

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:
  • 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

Treatment and study plan

DS-2330b PIB

Drug

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

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.

Other names: Sevelamer carbonate

DS-2330b Tablet

Drug

DS-2330b as tablet formulation

Primary outcomes

  1. Part A, Period 1: Maximum concentration (Cmax) of DS-2330a

    Time frame: Period 1, Pre-dose to 48 hours post-dose

  2. Part A, Period 2: Cmax of DS-2330a

    Time frame: Period 2, Pre-dose to 48 hours post-dose

  3. Part A, Period 1: Time to maximum concentration (Tmax) of DS-2330a

    Time frame: Period 1, Pre-dose to 48 hours post-dose

  4. Part A, Period 2: Tmax of DS-2330a

    Time frame: Period 2, Pre-dose to 48 hours post-dose

  5. 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

  6. 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

  7. Part A, Period 1: AUC at the last observable concentration (AUClast) and to infinity (AUCinf) for DS-2330a

    Time frame: Period 1, Pre-dose to 48 hours post-dose

    Categories (with the same unit of measure ng*hr/mL): AUClast, AUCinf

  8. Part A, Period 2: AUClast and AUCinf for DS-2330a

    Time frame: Period 2, Pre-dose to 48 hours post-dose

    Categories (with the same unit of measure ng*hr/mL): AUClast, AUCinf

  9. Parts B and C: Serum phosphate (Pi) levels before hemodialysis

    Time frame: within 15 days

  10. All Parts: Number of trial participants with treatment-emergent adverse events (TEAEs)

    Time frame: 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.

Secondary outcomes

  1. Parts B and C: Cmax of DS-2330a

    Time frame: within 24 hours on Day 1

  2. Parts B and C: Cmax of DS-2330a

    Time frame: within 24 hours on Day 13

  3. Parts B and C: Tmax of DS-2330a

    Time frame: within 24 hours, Day 1

  4. Parts B and C: Tmax of DS-2330a

    Time frame: within 24 hours, Day 13

  5. Parts B and C: AUC-24 for DS-2330a

    Time frame: Day 1

  6. Parts B and C: AUC-24 for DS-2330a

    Time frame: Day 13

  7. Parts B and C: AUCinf for DS-2330a

    Time frame: Day 1

  8. Parts B and C: AUCinf for DS-2330a

    Time frame: Day 13

  9. Parts B and C: Minimum concentration (Ctrough) of DS-2330a

    Time frame: within 11 days

    Trough blood levels for DS-2330a will be collected before the morning dose (prior to breakfast)

  10. Part B: Dialysis clearance of DS-2330a

    Time frame: on Day 11

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 10, 2017
Registry last updated
Mar 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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