A Phase 1 interventional study of Vadadustat and Simvastatin in Drug Interaction Potentiation, sponsored by Akebia Therapeutics. Completed at 1 site in Canada. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-22.
Sponsored by Akebia Therapeutics · Phase 1, Interventional, and Basic science
This is a Phase 1, three-part, open-label study to evaluate vadadustat as a perpetrator in drug-drug interactions with rosuvastatin, sulfasalazine, pravastatin, atorvastatin and simvastatin in healthy male and female subjects.
This is a Phase 1, three-part, open-label study to evaluate vadadustat as a perpetrator in drug-drug interactions with rosuvastatin, sulfasalazine, pravastatin, atorvastatin, and simvastatin in healthy male and female subjects. Thirty-four (34) subjects will be enrolled in Part 1 (rosuvastatin) and based on review of the PK and safety/tolerability data, a decision will be made on whether to proceed with Part 2. Part 2 consists of 2 arms (sulfasalazine and pravastatin). Twenty-six (26) subjects will be enrolled into each arm. Part 3 consists of 2 arms (atorvastatin and simvastatin). Twenty-four (24) subjects will be enrolled into each arm after enrollment in Part 2 is completed. Subjects will be in the study for up to 72 days, including a 28-day screening period, 6-14 day in clinic period, and a 30-day follow up period post last dose. Blood samples for PK analysis will be collected at pre-defined time points throughout the study.
Akebia Therapeutics is the lead sponsor of 37 studies on the registry; 3 are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 12 (55%) have results posted.
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Part 1: Subjects will receive rosuvastatin 20 mg alone, vadadustat 600 mg alone, followed by rosuvastatin 20 mg in combination with vadadustat 600 mg in a fixed-sequence dosing design.
Drug: Vadadustat · Drug: Rosuvastatin
Part 2, Arm 1: Subjects will receive sulfasalazine 500 mg alone followed by sulfasalazine 500 mg in combination with vadadustat 600 mg once a day in a fixed-sequence dosing design. Part 2, Arm 2: Subjects will receive pravastatin 40 mg alone followed by pravastatin 40 mg in combination with vadadustat 600 mg once a day in a fixed-sequence dosing design.
Drug: Vadadustat · Drug: Pravastatin · Drug: Sulfasalazine
Part 3, Arm 1: Subjects will receive atorvastatin 40 mg alone followed by atorvastatin 40 mg in combination with vadadustat 600 mg once a day in a fixed-sequence dosing design. Part 3, Arm 2: 24 subjects will receive simvastatin 40 mg alone followed by simvastatin 40 mg in combination with vadadustat 600 mg once a day in a fixed-sequence dosing design.
Drug: Vadadustat · Drug: Simvastatin · Drug: Atorvastatin
Oral dose of 600 mg QD
Also known as: AKB 6548
Oral Simvastatin
Oral Rosuvastatin
Oral Atorvastatin
Oral Pravastatin
Oral Sulfasalazine
Area under plasma concentration-time curve from time 0 to last quantifiable concentration (AUClast) of rosuvastatin, sulfasalazine, pravastatin and simvastatin
Time frame: Up to 10 weeks
Area under plasma concentration-time curve from time 0 to infinity (AUCinf) of rosuvastatin, sulfasalazine, pravastatin and simvastatin
Time frame: Up to 10 weeks
Maximum observed plasma concentration (Cmax) of rosuvastatin. sulfasalazine, pravastatin, atorvastatin and simvastatin
Time frame: Up to 10 weeks
Area under plasma concentration-time curve (AUCtau) of atorvastatin
Time frame: Up to 10 weeks
Time to maximum observed plasma concentration (Tmax) of rosuvastatin, sulfasalazine, pravastatin, atorvastatin, and simvastatin
Time frame: Up to 10 weeks
Elimination rate constant (Kel) of rosuvastatin, sulfasalazine, pravastatin, atorvastatin, and simvastatin
Time frame: Up to 10 weeks
Terminal half-life (t½) of rosuvastatin, sulfasalazine, pravastatin, atorvastatin, and simvastatin
Time frame: Up to 10 weeks
Apparent total body clearance (CL/F) of rosuvastatin, sulfasalazine, pravastatin, atorvastatin, and simvastatin
Time frame: Up to 10 weeks
Percentage of extrapolated area under the curve from time t to infinity (%AUCextrap or Residual Area) of rosuvastatin, sulfasalazine, pravastatin, atorvastatin, and simvastatin
Time frame: Up to 10 weeks
Area under plasma concentration-time curve from time 0 to last quantifiable concentration (AUClast) of sulfasalazine metabolites, sulfapyridine and 5-ASA (mesalamine
Time frame: Up to 10 weeks
Area under plasma concentration-time curve from time 0 to infinity (AUCinf) of sulfasalazine metabolites, sulfapyridine and 5-ASA (mesalamine
Time frame: Up to 10 weeks
Maximum observed plasma concentration (Cmax) of sulfasalazine metabolites, sulfapyridine and 5-ASA (mesalamine
Time frame: Up to 10 weeks
Time to maximum observed plasma concentration (Tmax) of sulfasalazine metabolites, sulfapyridine and 5-ASA (mesalamine
Time frame: Up to 10 weeks
Elimination rate constant (Kel) of sulfasalazine metabolites, sulfapyridine and 5-ASA (mesalamine
Time frame: Up to 10 weeks
Terminal half-life (t½) of sulfasalazine metabolites, sulfapyridine and 5-ASA (mesalamine
Time frame: Up to 10 weeks
Area under the plasma concentration-time curve for a dosing interval (AUCtau) of atorvastatin metabolites, o-hydroxyatorvastatin; p-hydroxyatorvastatin
Time frame: Up to 10 weeks
Maximum observed plasma concentration (Cmax) of atorvastatin metabolites, o-hydroxyatorvastatin; p-hydroxyatorvastatin
Time frame: Up to 10 weeks
Time to maximum observed plasma concentration (Tmax) of atorvastatin metabolites, o-hydroxyatorvastatin; p-hydroxyatorvastatin
Time frame: Up to 10 weeks
Area under plasma concentration-time curve from time 0 to last quantifiable concentration (AUClast) of simvastatin metabolite
Time frame: Up to 10 weeks
Area under plasma concentration-time curve from time 0 to infinity (AUCinf) of simvastatin metabolite
Time frame: Up to 10 weeks
Maximum observed plasma concentration (Cmax) of simvastatin metabolite
Time frame: Up to 10 weeks
Time to maximum observed plasma concentration (Tmax) of simvastatin metabolite
Time frame: Up to 10 weeks
Elimination rate constant (Kel) of simvastatin metabolite
Time frame: Up to 10 weeks
Terminal half-life (t½), of simvastatin metabolite
Time frame: Up to 10 weeks
Reporting of treatment emergent adverse events (TEAE) as reported by the study subjects
Time frame: Up to 10 weeks
Plan to share: Undecided
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This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Vadadustat · Simvastatin · Rosuvastatin · Atorvastatin · Pravastatin · Sulfasalazine