Status:
COMPLETED
Drug-Drug Interaction Study of Vadadustat With Rosuvastatin, Sulfasalazine, Pravastatin, Atorvastatin and Simvastatin
Lead Sponsor:
Akebia Therapeutics
Conditions:
Drug Interaction Potentiation
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
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 health...
Eligibility Criteria
Inclusion
- Healthy Male or female between 18 and 55 years of age, inclusive, at time of informed consent
- Body mass index between 18.0 and 30.0 kg/m2, with a minimum body weight of 45 kg for females and 50 kg for males, inclusive.
Exclusion
- Current or past clinically significant history of cardiovascular, cerebrovascular, pulmonary, gastrointestinal, hematologic, renal, hepatic, immunologic, metabolic, urologic, neurologic, dermatologic, psychiatric, or other major disease. History of cancer (except treated non-melanoma skin cancer) or history of chemotherapy use within 5 years prior to Screening; History of latent or active tuberculosis (TB).
- Positive test results for human immunodeficiency virus (HIV) antibody; 12. Positive test results of hepatitis B surface antigen (HBsAg), or positive hepatitis C virus antibody (HCVab) within 3 months prior to screening, or positive test results for human immunodeficiency virus antibody (HIVab) at Screening
- Taking any prescription medication or over the counter multi-vitamin supplement, or any non-prescription products (including herbal-containing preparations but excluding acetaminophen) within 14 days prior to Day -1.
Key Trial Info
Start Date :
June 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 24 2018
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT03801733
Start Date
June 17 2018
End Date
November 24 2018
Last Update
March 22 2019
Active Locations (1)
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1
InVentiv Health Clinique Inc.
Québec, Quebec, Canada, G1P A02