Drug Interaction Potentiation Clinical Trial
Official title:
A Phase 1, Two-Part, Open-label Study in Healthy Adult Volunteers to Assess a Single Dose of Vadadustat as a Victim in Drug-Drug Interactions With Cyclosporine, Probenecid and Rifampin
This is a Phase 1, two-part, open-label study to evaluate the interaction of cyclosporine, probenecid, and rifampin as perpetrators with vadadustat (victim) in healthy male and female subjects.
This is a Phase 1, two-part, open-label study to evaluate the interaction of cyclosporine, probenecid, and rifampin as perpetrators with vadadustat (victim) in healthy male and female subjects. Part 1 consists of 2 arms (cyclosporine and probenecid) and Part 2 consists of 1 arm (rifampin). Twenty (20) unique subjects will be enrolled into each study arm. The PK and safety/tolerability data from Part 1 Arm 1 (cyclosporine) will determine if Part 2 (rifampin) will proceed. Subjects will be on study for up to 72 days, including a 28-day screening period, 6-10 day clinic period, and a 30-day follow-up period post last dose. Blood and/or urine samples for PK analysis will be collected at pre-defined timepoints throughout the study. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03789032 -
Study to Evaluate the Effect of Rabeprazole on the Pharmacokinetics of Vadadustat
|
Phase 1 | |
| Completed |
NCT03706222 -
Drug-Drug Interactions of Grazoprevir/Elbasvir in Taiwan
|
||
| Completed |
NCT02191358 -
YouScript IMPACT Registry
|
N/A | |
| Completed |
NCT02485028 -
Pharmacokinetic Interaction Study of Dapoxetine 30mg and Mirodenafil 50mg
|
Phase 1 | |
| Completed |
NCT01896557 -
Ranitidin Versus Omeprazole in Patients Taking Clopidogrel
|
Phase 4 | |
| Completed |
NCT03011463 -
Pharmacokinetic Interaction Between Trospium With an Inhibitor of OCT1 and of P-gp in Subjects Genotyped for OCT1
|
Phase 1 | |
| Completed |
NCT02485041 -
Pharmacokinetic Interaction Study of Dapoxetine 30mg and Mirodenafil 100mg
|
Phase 1 | |
| Completed |
NCT01477411 -
A Drug-Drug Interaction Study of Digoxin and PA21
|
Phase 1 | |
| Completed |
NCT01477424 -
A Drug-Drug Interaction Study of Warfarin and PA21
|
Phase 1 | |
| Completed |
NCT05558150 -
Study to Evaluate Pharmacokinetic Drug Interactions and Safety of Ilaprazole and Aceclofenac
|
Phase 1 | |
| Completed |
NCT03493698 -
A Fixed-Sequence, Drug-Drug Interaction Study Between Multiple Oral Doses of Inarigivir Soproxil and a Single Oral Dose of Midazolam in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT03126578 -
Open-label, Single Center, Non-randomized, Fixed Sequence Phase 1 Drug-drug Interaction Study With LEO 32731 and Midazolam
|
Phase 1 | |
| Completed |
NCT01369186 -
Drug Drug Interactions of Aspirin and P2Y12-inhibitors
|
Phase 4 | |
| Completed |
NCT02378220 -
Pharmacogenetic Testing Among Home Health Patients
|
N/A | |
| Completed |
NCT01324752 -
A Drug-Drug Interaction Study of Losartan and PA21
|
Phase 1 | |
| Completed |
NCT02500667 -
A Drug-Drug Interaction Study of N91115 +/- Rifampin in Healthy Adult Subjects
|
Phase 1 | |
| Completed |
NCT03801733 -
Drug-Drug Interaction Study of Vadadustat With Rosuvastatin, Sulfasalazine, Pravastatin, Atorvastatin and Simvastatin
|
Phase 1 | |
| Completed |
NCT03801759 -
Drug-Drug Interaction Study of Vadadustat With Digoxin, Adefovir and Furosemide
|
Phase 1 | |
| Completed |
NCT01736371 -
Analysis of Cisatracurium Consumption in Balanced Anesthesia With 1% Sevoflurane, and With Only Sevoflurane, Using a Closed-loop Computer Controlled System Infusion.
|
N/A | |
| Completed |
NCT05237297 -
Study to Evaluate Pharmacokinetic Drug Interactions and Safety of Naproxen, Aceclofenac, Celecoxib and Ilaprazole
|
Phase 1 |