HealthyPhase 1NCT03657290
A Study in Evaluating Bioequivalence of Test and Reference Vadadustat 450 MG and 150 MG Tablets and to Determine Food Effect on the 450 MG Tablet
A Phase 1 study testing vadadustat in people with Healthy, run by Akebia Therapeutics at 1 site in United States.
Trial summary
This is a healthy volunteers study to assess the bioequivalence of vadadustat 450 mg tablets (Test A) compared to three 150mg tablets (Reference B). The study will also assess the effect of food on the bioavailability of vadadustat 450 mg tablet. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- vadadustat
- 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 siteUnited States
- Study dates
- 3 Aug 2018to 16 Oct 2018
- 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 subjects between ≥18 years and ≤55 years of age
- Healthy subjects per Investigator judgment as documented by the medical history, physical examination, vital sign assessments, 12-lead electrocardiogram (ECG), clinical laboratory assessments, and general observations.
- Have a body weight ≥50 kg and body mass index (BMI) ≥18.5 kg/m2 to 29.5 kg/m2 inclusive
- Understands the procedures, provides ICF and willing to comply with study requirements
- Willing and able to comply with the requirements of the study protocol.
Who cannot join
- Current or past history of cardiovascular, cerebrovascular, pulmonary, gastrointestinal, hematologic, renal, hepatic, immunologic, metabolic, urologic, neurologic, dermatologic, psychiatric, or other major disease.
- History of cancer (except non- melanoma skin cancer) or history of chemotherapy use.
- Any surgical or medical condition or history that 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.
- History of severe allergic or anaphylactic reactions. Chronic daily medication use.
- History of drug abuse Excessive alcohol consumption.
- Smoking and the use of nicotine-containing products
Show all 10Show fewer
- Consumption of grapefruit or grapefruit juice, pomelo, star fruit, Seville or Moro (blood) orange, or their associated products
- Participation in another clinical trial or exposure to any investigational agent.
- Donation of blood or significant blood loss or plasma donation.
- Any condition that would interfere with the ability to provide informed consent, comply with study instructions, or which might confound the interpretation of the study results or put the patient at undue risk.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-Label, Single-Dose, Three-Period Six-Sequence Crossover Study in Healthy Adults to Assess Bioequivalence Between Test and Reference Vadadustat 450 mg and 150 mg Tablets and to Determine Food Effect on the 450 mg Vadadustat Tablet.
This is a healthy volunteers study to assess the bioequivalence of vadadustat 450 mg tablets (Test A) compared to three 150mg tablets (Reference B). The study will also assess the effect of food on the bioavailability of vadadustat 450 mg tablet.
Read the detailed description
This is a randomized, open-label, single-dose, three-period crossover study in healthy adults to assess the bioequivalence of 3 X 150 mg vadadustat tablets (Test) compared to a single 450 mg vadadustat tablet (reference). Blood samples for vadadustat PK will be collected at pre-dose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12, 18, 24, 32, 40, and 48 hours post-dose. The study will also assess the effect of food on vadadustat bioavailability by evaluating the pharmacokinetics of the 450 mg tablet in fed and fasted subjects.
- Conditions
- Healthy
- Being tested
- vadadustat
- Keywords
- Vadadustat, healthy volunteers, bioequivalence, pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vadadustatDrug
Also called AKB-6548
Vadadustat Tablets
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Active comparator | vadadustat 3 X 150 mg Tablets in fasted subjects Receives: Drug: vadadustat |
| Treatment B | Active comparator | Vadadustat 1 X 450 mg Tablets in fasted subjects Receives: Drug: vadadustat |
| Treatment C | Active comparator | vadadustat 1 X 450 mg Tablets in fed subjects Receives: Drug: vadadustat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence - Area under plasma concentration-time curve from 0 to last quantifiable concentration (AUClast)
Measured: Baseline visit, 48 hours
Bioequivalence - Area under plasma concentration-time curve from 0 to infinity (AUCinf)
Measured: Baseline visit, 48 hours
Bioequivalence - Area under plasma concentration-time curve from 0 to last sampling point (AUCall)
Measured: Baseline visit, 48 hours
Bioequivalence - Observed Maximum concentration (Cmax)
Measured: Baseline visit, 48 hours
Measure Food Effect - Area under plasma concentration-time curve from 0 to last quantifiable concentration (AUClast)
Measured: Baseline visit, 48 hours
Measure Food Effect - 2. Area under plasma concentration-time curve from 0 to infinity (AUCinf)
Measured: Baseline visit, 48 hours
Measure Food Effect - 2.3. Observed Maximum concentration (Cmax)
Measured: Baseline visit, 48 hours
Secondary outcomes (8)
Time to reach Cmax
Measured: Baseline visit, 48 hours
Time to reach Tmax
Measured: Baseline visit, 48 hours
Mean residence time (MRT)
Measured: Baseline visit, 48 hours
Elimination rate constant (Kel)
Measured: Baseline visit, 48 hours
Apparent total body clearance (CL/F)
Measured: Baseline visit, 48 hours
Apparent volume of distribution (Vd/F)
Measured: Baseline visit, 48 hours
Terminal half-life (t1/2)
Measured: Baseline visit, 48 hours
Percentage of extrapolated area under the curve from time t to infinity (AUCextrap or Residual Area)
Measured: Baseline visit, 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start3 Aug 2018
- Primary completion16 Oct 2018
- Study completion16 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Crossover
- Model description
- This is a randomized, open-label, single-dose, three-period, six- sequence crossover study in healthy adults. A total of 54 eligible subjects will be randomized to one of six treatment sequences (ABC, ACB, BAC, BCA, CAB, or CBA). Refer to Treatment Sequences below. Each sequence is comprised of 3 treatments
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akebia Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Akebia Therapeutics, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03657290
- Sponsor's protocol ID
- AKB-6548-CI-0028
- Status last verified
- Mar 2019
- First submitted
- 31 Aug 2018
- Last updated
- 22 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Single-Dose, Three-Period Six-Sequence Crossover Study in Healthy Adults to Assess Bioequivalence Between Test and Reference Vadadustat 450 mg and 150 mg Tablets and to Determine Food Effect on the 450 mg Vadadustat Tablet.
- ClinicalTrials.gov ID
- NCT03657290
- Acronym / sponsor ID
- AKB-6548-CI-0028
- Conditions
- Healthy
- Keywords
- Vadadustat, healthy volunteers, bioequivalence, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Akebia TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 3 Aug 2018 (actual)
- Primary completion
- 16 Oct 2018 (actual)
- Study completion
- 16 Oct 2018 (actual)
- First posted
- 5 Sep 2018 (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 is a healthy volunteers study to assess the bioequivalence of vadadustat 450 mg tablets (Test A) compared to three 150mg tablets (Reference B). The study will also assess the effect of food on the bioavailability of vadadustat 450 mg tablet.
Detailed description
This is a randomized, open-label, single-dose, three-period crossover study in healthy adults to assess the bioequivalence of 3 X 150 mg vadadustat tablets (Test) compared to a single 450 mg vadadustat tablet (reference). Blood samples for vadadustat PK will be collected at pre-dose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12, 18, 24, 32, 40, and 48 hours post-dose. The study will also assess the effect of food on vadadustat bioavailability by evaluating the pharmacokinetics of the 450 mg tablet in fed and fasted subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a randomized, open-label, single-dose, three-period, six- sequence crossover study in healthy adults. A total of 54 eligible subjects will be randomized to one of six treatment sequences (ABC, ACB, BAC, BCA, CAB, or CBA). Refer to Treatment Sequences below. Each sequence is comprised of 3 treatments
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Active comparator | Drug: vadadustatvadadustat 3 X 150 mg Tablets in fasted subjects |
| Treatment B | Active comparator | Drug: vadadustatVadadustat 1 X 450 mg Tablets in fasted subjects |
| Treatment C | Active comparator | Drug: vadadustatvadadustat 1 X 450 mg Tablets in fed subjects |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female subjects between ≥18 years and ≤55 years of age
- Healthy subjects per Investigator judgment as documented by the medical history, physical examination, vital sign assessments, 12-lead electrocardiogram (ECG), clinical laboratory assessments, and general observations.
- Have a body weight ≥50 kg and body mass index (BMI) ≥18.5 kg/m2 to 29.5 kg/m2 inclusive
- Understands the procedures, provides ICF and willing to comply with study requirements
- Willing and able to comply with the requirements of the study protocol.
Key exclusion criteria (10 listed)
- Current or past history of cardiovascular, cerebrovascular, pulmonary, gastrointestinal, hematologic, renal, hepatic, immunologic, metabolic, urologic, neurologic, dermatologic, psychiatric, or other major disease.
- History of cancer (except non- melanoma skin cancer) or history of chemotherapy use.
- Any surgical or medical condition or history that 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.
- History of severe allergic or anaphylactic reactions. Chronic daily medication use.
- History of drug abuse Excessive alcohol consumption.
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 |
|---|---|---|
| vadadustatAlso: AKB-6548Vadadustat Tablets | Drug | Treatment A, Treatment B, Treatment C |
Primary outcome
Bioequivalence - Area under plasma concentration-time curve from 0 to last quantifiable concentration (AUClast)
Time frame: Baseline visit, 48 hours
Bioequivalence - Area under plasma concentration-time curve from 0 to infinity (AUCinf)
Time frame: Baseline visit, 48 hours
Bioequivalence - Area under plasma concentration-time curve from 0 to last sampling point (AUCall)
Time frame: Baseline visit, 48 hours
Bioequivalence - Observed Maximum concentration (Cmax)
Time frame: Baseline visit, 48 hours
Measure Food Effect - Area under plasma concentration-time curve from 0 to last quantifiable concentration (AUClast)
Time frame: Baseline visit, 48 hours
Measure Food Effect - 2. Area under plasma concentration-time curve from 0 to infinity (AUCinf)
Time frame: Baseline visit, 48 hours
Measure Food Effect - 2.3. Observed Maximum concentration (Cmax)
Time frame: Baseline visit, 48 hours
8 secondary outcomes
Time to reach Cmax
Time frame: Baseline visit, 48 hours
Time to reach Tmax
Time frame: Baseline visit, 48 hours
Mean residence time (MRT)
Time frame: Baseline visit, 48 hours
Elimination rate constant (Kel)
Time frame: Baseline visit, 48 hours
Apparent total body clearance (CL/F)
Time frame: Baseline visit, 48 hours
Apparent volume of distribution (Vd/F)
Time frame: Baseline visit, 48 hours
Terminal half-life (t1/2)
Time frame: Baseline visit, 48 hours
Percentage of extrapolated area under the curve from time t to infinity (AUCextrap or Residual Area)
Time frame: Baseline visit, 48 hours
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 22 Mar 2019.
- Individual participant dataSharing planned: Undecided
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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.
Akebia Therapeutics study director
Sponsor GmbH
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 in people with Healthy, run by Akebia Therapeutics at 1 site in United States.
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 5 inclusion and 10 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 22 Mar 2019. 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 United States. 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?
Bioequivalence - Area under plasma concentration-time curve from 0 to last quantifiable concentration (AUClast) (time frame: Baseline visit, 48 hours). The study lists 7 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 22 Mar 2019.