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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03801733
Other study ID # AKB 6548 CI 0030
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date June 17, 2018
Est. completion date November 24, 2018

Study information

Verified date March 2019
Source Akebia Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 male and female subjects.


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 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.


Recruitment information / eligibility

Status Completed
Enrollment 134
Est. completion date November 24, 2018
Est. primary completion date November 24, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- 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 Criteria:

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Vadadustat
Oral dose of 600 mg QD
Simvastatin
Oral Simvastatin
Rosuvastatin
Oral Rosuvastatin
Atorvastatin
Oral Atorvastatin
Pravastatin
Oral Pravastatin
Sulfasalazine
Oral Sulfasalazine

Locations

Country Name City State
Canada InVentiv Health Clinique Inc. Québec City Quebec

Sponsors (1)

Lead Sponsor Collaborator
Akebia Therapeutics

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Area under plasma concentration-time curve from time 0 to last quantifiable concentration (AUClast) of rosuvastatin, sulfasalazine, pravastatin and simvastatin Up to 10 weeks
Primary Area under plasma concentration-time curve from time 0 to infinity (AUCinf) of rosuvastatin, sulfasalazine, pravastatin and simvastatin Up to 10 weeks
Primary Maximum observed plasma concentration (Cmax) of rosuvastatin. sulfasalazine, pravastatin, atorvastatin and simvastatin Up to 10 weeks
Primary Area under plasma concentration-time curve (AUCtau) of atorvastatin Up to 10 weeks
Secondary Time to maximum observed plasma concentration (Tmax) of rosuvastatin, sulfasalazine, pravastatin, atorvastatin, and simvastatin Up to 10 weeks
Secondary Elimination rate constant (Kel) of rosuvastatin, sulfasalazine, pravastatin, atorvastatin, and simvastatin Up to 10 weeks
Secondary Terminal half-life (t½) of rosuvastatin, sulfasalazine, pravastatin, atorvastatin, and simvastatin Up to 10 weeks
Secondary Apparent total body clearance (CL/F) of rosuvastatin, sulfasalazine, pravastatin, atorvastatin, and simvastatin Up to 10 weeks
Secondary Percentage of extrapolated area under the curve from time t to infinity (%AUCextrap or Residual Area) of rosuvastatin, sulfasalazine, pravastatin, atorvastatin, and simvastatin Up to 10 weeks
Secondary Area under plasma concentration-time curve from time 0 to last quantifiable concentration (AUClast) of sulfasalazine metabolites, sulfapyridine and 5-ASA (mesalamine Up to 10 weeks
Secondary Area under plasma concentration-time curve from time 0 to infinity (AUCinf) of sulfasalazine metabolites, sulfapyridine and 5-ASA (mesalamine Up to 10 weeks
Secondary Maximum observed plasma concentration (Cmax) of sulfasalazine metabolites, sulfapyridine and 5-ASA (mesalamine Up to 10 weeks
Secondary Time to maximum observed plasma concentration (Tmax) of sulfasalazine metabolites, sulfapyridine and 5-ASA (mesalamine Up to 10 weeks
Secondary Elimination rate constant (Kel) of sulfasalazine metabolites, sulfapyridine and 5-ASA (mesalamine Up to 10 weeks
Secondary Terminal half-life (t½) of sulfasalazine metabolites, sulfapyridine and 5-ASA (mesalamine Up to 10 weeks
Secondary Area under the plasma concentration-time curve for a dosing interval (AUCtau) of atorvastatin metabolites, o-hydroxyatorvastatin; p-hydroxyatorvastatin Up to 10 weeks
Secondary Maximum observed plasma concentration (Cmax) of atorvastatin metabolites, o-hydroxyatorvastatin; p-hydroxyatorvastatin Up to 10 weeks
Secondary Time to maximum observed plasma concentration (Tmax) of atorvastatin metabolites, o-hydroxyatorvastatin; p-hydroxyatorvastatin Up to 10 weeks
Secondary Area under plasma concentration-time curve from time 0 to last quantifiable concentration (AUClast) of simvastatin metabolite Up to 10 weeks
Secondary Area under plasma concentration-time curve from time 0 to infinity (AUCinf) of simvastatin metabolite Up to 10 weeks
Secondary Maximum observed plasma concentration (Cmax) of simvastatin metabolite Up to 10 weeks
Secondary Time to maximum observed plasma concentration (Tmax) of simvastatin metabolite Up to 10 weeks
Secondary Elimination rate constant (Kel) of simvastatin metabolite Up to 10 weeks
Secondary Terminal half-life (t½), of simvastatin metabolite Up to 10 weeks
Secondary Reporting of treatment emergent adverse events (TEAE) as reported by the study subjects Up to 10 weeks
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