Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: vadadustat plus sevelamer carbonate | Experimental | Participants will receive vadadustat 300 milligrams (mg) once on Days 1, 3, 5, and 7. Participants will receive sevelamer carbonate 1600 mg once on Days 3, 5, and 7. |
|
| Part 2: vadadustat plus calcium acetate | Experimental | Participants will receive vadadustat 300 mg once on Days 1, 3, 5, and 7. Participants will receive calcium acetate 1334 mg once on Days 3, 5, and 7. |
|
| Part 3: vadadustat plus Auryxia® | Experimental | Participants will receive vadadustat 300 mg once on Days 1, 3, 5, and 7. Participants will receive Auryxia® 2 grams once on Days 3, 5, and 7. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vadadustat | Drug | 2 x 150 mg oral tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vadadustat area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUClast) | 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, and 48 hours after each dose of vadadustat in each 9-day study part | |
| Vadadustat area under the plasma concentration-time curve from time 0 to infinity (AUCinf) | 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, and 48 hours after each dose of vadadustat in each 9-day study part | |
| Maximum observed plasma concentration (Cmax) of vadadustat | 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, and 48 hours after each dose of vadadustat in each 9-day study part |
Not provided
Not provided
Inclusion Criteria:
Male or female between 18 and 55 years of age, inclusive, at time of informed consent
Healthy per investigator judgment as documented by medical history, physical examination, vital sign assessments, 12-lead electrocardiogram (ECG), clinical laboratory assessments, and general observations
Body mass index (BMI) between 18.0 and 30 kilograms per meters squared (kg/m^2), with a minimum body weight of 45 kg for females and 50 kg for males, inclusive
Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure
Willing and able to comply with the requirements of the study protocol
Exclusion Criteria:
Current or past history of cardiovascular, cerebrovascular, respiratory, gastrointestinal, hematologic, renal, hepatic, immunologic, metabolic, urologic, neurologic, dermatologic, psychiatric, or other major disease, as determined by the investigator. History of cancer (except treated non-melanoma skin cancer) or history of chemotherapy use within 5 years prior to screening.
Any surgical or medical condition or history that, in the opinion of the investigator, may potentially alter the absorption, metabolism, or excretion of study treatment, such as, but not limited to gastric bypass surgery or gastric or duodenal ulcers
Clinically significant history of dysphagia, bowel obstruction, or perforation
Clinically significant history of hypercalcemia
Clinically significant history of iron overload
Clinically significant history of liver disease
Clinically significant history of hypophosphatemia, ulcerative colitis, or gastrointestinal bleeding
Contraindication to study drugs or its excipients and/or history of allergic or anaphylactic reactions
Taking any of the following prohibited medications:
History of drug abuse within the previous year prior to screening or use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine [PCP], crack, opioid derivatives including heroin, and amphetamine derivatives) within 1 year prior to screening
History of regular alcohol consumption exceeding 14 drinks/week (1 drink = 5 ounces [150 milliliters (mL)] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) within 6 months of screening or alcohol abuse within 1 year prior to screening
Positive drug and alcohol test at screening or on Day -1
History of latent or active tuberculosis (TB) as per documented medical history. Exposure to endemic areas within 8 weeks of screening
Daily use of nicotine-containing products within 6 months of screening
Consumed any food or drink/beverage containing grapefruit or grapefruit juice, apple or orange juice, pomelo juice, pomegranate, pineapple, star fruit, Seville or Moro (blood) orange products, and vegetables from the mustard green family (e.g., kale, broccoli, watercress, collard greens, kohlrabi, brussels sprouts, mustard) and charbroiled meats known to modulate CYP enzyme activity and transporters within 7 days before administration of study drug
Positive test results of hepatitis B surface antigen (HBsAg), or positive hepatitis C virus antibody (HCVab) test result within 3 months prior to Day -1 or at screening
Positive test results for human immunodeficiency virus (HIV) antibody within 3 months prior to Day -1 or at screening
Participation in another clinical trial or exposure to any investigational agent within 30 days or 5 half-lives prior to Day -1, whichever is longer
Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to the first dosing
Received a tattoo or body piercing (including ear piercings) within 2 months prior to Day 1, and/or open wound that may result in risk of infection
Having a condition that the investigator believes would interfere with his/her ability to provide written informed consent, comply with study instructions, or which might confound the interpretation of the study results or put the participant at undue risk
Have previously participated in a clinical study that administered vadadustat
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Québec | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000624313 | vadadustat |
| D000069603 | Sevelamer |
| C120662 | calcium acetate |
| C025314 | ferric citrate |
| ID | Term |
|---|---|
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sevelamer carbonate | Drug | 2 x 800 mg oral tablets |
|
| Calcium acetate | Drug | 2 x 667 mg oral gelcaps |
|
| Auryxia® | Drug | 2 x 1 gram tablets (210 mg ferric iron equivalent to 1000 mg ferric citrate) |
|