Study in Healthy Adult Subjects to Assess the Effect of Phosphate Binders on the Pharmacokinetics of a Single Dose of Vadadustat
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).
Timeline
- Start
- 2020-06-15
- Primary completion
- 2020-08-02
- Completion
- 2020-09-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Calcium carbonate | Other / unclassified | 1334 mg | Oral |
| Subject | KRX-0502 | Small molecule | 2 g | Oral |
| Subject | Vadadustat | Small molecule | 300 mg | Oral |
| Subject | sevelamer | Other / unclassified | 1600 mg | Oral |
Indications
No indication recorded.