Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-06-21 @ 5:19 PM
Study NCT ID:
NCT04299633
Status:
COMPLETED
Last Update Posted:
2020-10-08
First Post:
2020-03-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study in Healthy Adult Subjects to Assess the Effect of Phosphate Binders on the Pharmacokinetics of a Single Dose of Vadadustat
Sponsor:
Akebia Therapeutics
Organization:
Study Overview
Official Title:
A Phase 1, Three-Part, Open-Label Study in Healthy Adult Subjects to Assess the Effect of Phosphate Binders on the Pharmacokinetics of a Single Dose of Vadadustat
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This 3-part study will be conducted to evaluate the interaction of vadadustat with sevelamer carbonate, calcium acetate, and Auryxia in healthy male and female participants. A total of 18 participants will be enrolled in each part of the study. Part 1 of the study will be conducted to assess the effect of a single oral dose of sevelamer carbonate (1600 milligrams \[mg\]) on the pharmacokinetics (PK) of a single oral dose of vadadustat (300 mg). Part 2 of the study will be conducted to assess the effect of a single oral dose of calcium acetate (1334 mg) on the PK of a single oral dose of vadadustat (300 mg). Part 3 of the study will be conducted to assess the effect of a single oral dose of Auryxia® (2 grams) on the PK of a single oral dose of vadadustat (300 mg).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: