Healthy VolunteersPhase 1NCT04299633
Study in Healthy Adult Subjects to Assess the Effect of Phosphate Binders on the Pharmacokinetics of a Single Dose of Vadadustat
A Phase 1 study testing Vadadustat, Sevelamer carbonate and Calcium acetate in people with Healthy Volunteers, run by Akebia Therapeutics at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Vadadustat, Sevelamer carbonate and Calcium acetate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jun 2020to 28 Sep 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female between 18 and 55 years of age, inclusive, at time of informed consent
- Female participants of childbearing potential must be non-lactating, not pregnant as confirmed by a negative serum pregnancy test at screening and Day -1, and using, and agree to continue using, an effective method of contraception for at least of 4 weeks prior to the first dose of study drug until 30 days after the last dose of study drug. See the clinical trial protocol for acceptable methods of contraception prior to and during the study.
- Female participants of non-childbearing potential must be surgically sterile (e.g., hysterectomy, bilateral tubal ligation, oophorectomy) or post-menopausal (no menses for >1 year with follicle stimulating hormone [FSH] >40 Units per Liter (U/L) at screening).
- Female participants of childbearing potential must agree not to donate ova during the study and for at least 30 days after the last dose of study drug.
- Male participants who have not had a vasectomy for at least 6 months must agree to use an effective method of contraception during the study and until 90 days after the last dose of the study drug, and to not donate sperm during the study and for at least 90 days after the last dose of study drug. See the clinical trial protocol for acceptable methods of contraception prior to and during the study.
- Healthy per investigator judgment as documented by medical history, physical examination, vital sign assessments, 12-lead electrocardiogram (ECG), clinical laboratory assessments, and general observations
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- At screening, abnormalities or deviations outside the normal ranges for any clinical assessments (laboratory tests, ECG, vital signs) may be repeated once at the discretion of the investigator(s), and results that continue to be outside the normal ranges must be judged by the investigator to be not clinically significant and acceptable for study participation.
- On Day -1, alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin values must be within the upper limits of the normal range. All other laboratory test results that are outside the normal range on Day -1 and judged by the investigator to be not clinically significant may be repeated. Results that continue to be outside the normal range must be judged by the investigator to be not clinically significant and acceptable for study participation.
- 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
Who cannot join
- 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
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- 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:
- Any prescription medication or over the counter multi-vitamin supplement, or any nonprescription products (including herbal-containing preparations but excluding acetaminophen up to 2 grams daily) within 14 days prior to Day -1;
- Any drug known to inhibit or induce cytochrome P450 (CYP) enzymes and/or P glycoprotein including St. John's wort (Hypericum perforatum) within 14 days or 5 half-lives (whichever is longer) prior to Day -1
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Three-Part, Open-Label Study in Healthy Adult Subjects to Assess the Effect of Phosphate Binders on the Pharmacokinetics of a Single Dose of Vadadustat
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).
- Conditions
- Healthy Volunteers
- Being tested
- Vadadustat, Sevelamer carbonate, Calcium acetate, Auryxia®
- Keywords
- Healthy volunteers, Pharmacokinetics, Phosphate binders, Sevelamer carbonate, Calcium acetate, Auryxia®, Vadadustat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VadadustatDrug
2 x 150 mg oral tablets
Sevelamer carbonateDrug
2 x 800 mg oral tablets
Calcium acetateDrug
2 x 667 mg oral gelcaps
Auryxia®Drug
2 x 1 gram tablets (210 mg ferric iron equivalent to 1000 mg ferric citrate)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Vadadustat; Drug: Sevelamer carbonate |
| 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. Receives: Drug: Vadadustat; Drug: Calcium acetate |
| 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. Receives: Drug: Vadadustat; Drug: Auryxia® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vadadustat area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUClast)
Measured: 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)
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start15 Jun 2020
- Primary completion2 Aug 2020
- Study completion28 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akebia Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04299633
- Sponsor's protocol ID
- AKB-6548-CI-0037
- Status last verified
- Oct 2020
- First submitted
- 5 Mar 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Three-Part, Open-Label Study in Healthy Adult Subjects to Assess the Effect of Phosphate Binders on the Pharmacokinetics of a Single Dose of Vadadustat
- ClinicalTrials.gov ID
- NCT04299633
- Acronym / sponsor ID
- AKB-6548-CI-0037
- Conditions
- Healthy Volunteers
- Keywords
- Healthy volunteers, Pharmacokinetics, Phosphate binders, Sevelamer carbonate, Calcium acetate, Auryxia®, Vadadustat
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Akebia TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 2 Aug 2020 (actual)
- Study completion
- 28 Sep 2020 (actual)
- First posted
- 9 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1: vadadustat plus sevelamer carbonate | Experimental | Drug: Vadadustat, Drug: Sevelamer carbonateParticipants 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 | Drug: Vadadustat, Drug: Calcium acetateParticipants 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 | Drug: Vadadustat, Drug: Auryxia®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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vadadustat2 x 150 mg oral tablets | Drug | Part 1: vadadustat plus sevelamer carbonate, Part 2: vadadustat plus calcium acetate, Part 3: vadadustat plus Auryxia® |
| Sevelamer carbonate2 x 800 mg oral tablets | Drug | Part 1: vadadustat plus sevelamer carbonate |
| Calcium acetate2 x 667 mg oral gelcaps | Drug | Part 2: vadadustat plus calcium acetate |
| Auryxia®2 x 1 gram tablets (210 mg ferric iron equivalent to 1000 mg ferric citrate) | Drug | Part 3: vadadustat plus Auryxia® |
Primary outcome
Vadadustat area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUClast)
Time frame: 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)
Time frame: 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
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vadadustat, Sevelamer carbonate and Calcium acetate in people with Healthy Volunteers, run by Akebia Therapeutics at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vadadustat area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUClast) (time frame: 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.