HealthyPhase 1NCT02412449
Relative Bioavailability of Two Formulations of AKB-6548 and the Food Effect of a New Tablet in Healthy Adult Subjects
A Phase 1 study testing AKB-6548 tablet, reference formulation given in the fasted state, AKB-6548 tablet, test formulation given in the fasted state. and AKB-6548 tablet, test formulation given in the fed state in people with Healthy, run by Akebia Therapeutics at 1 site in United States.
Trial summary
The primary purpose of this study is to compare the PK parameters of a single dose of a test tablet formulation of AKB-6548 relative to a single dose of the reference AKB-6548 tablet formulation, both treatments administered without food, and to compare the PK parameters of the test tablet formulation given under fed… 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?
- AKB-6548 tablet, reference formulation given in the fasted state, AKB-6548 tablet, test formulation given in the fasted state. and AKB-6548 tablet, test formulation given in the fed state
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Apr 2015
- 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
- Healthy male and female subjects between 18 and 55 years of age, inclusive, and with a body mass index between 18 and 30 kg/m2, inclusive.
Who cannot join
- Current or past history of cardiovascular, cerebrovascular, pulmonary, renal or liver disease.
- Positive serology results for HBsAg, HCV, and HIV at Screening.
- Significant renal impairment as evidenced by an estimated glomerular filtration rate (eGFR) of <65 mL/min
- Known active cancer (except non-melanoma skin cancer) or history of chemotherapy use within the previous 24 months.
- Current or past history of gastric or duodenal ulcers or other diseases of the GI tract (including gastric bypass surgeries) that could interfere with absorption of study drug.
- Subjects with a known history of smoking and/or have used nicotine or nicotine-containing products within the past 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-Label, Single-Dose, Three-Period Crossover Study in Healthy Adults to Assess the Relative Bioavailability of Test and Reference Formulations of AKB-6548 Tablets and to Evaluate the Effect of Food on the Bioavailability of AKB-6548
The primary purpose of this study is to compare the PK parameters of a single dose of a test tablet formulation of AKB-6548 relative to a single dose of the reference AKB-6548 tablet formulation, both treatments administered without food, and to compare the PK parameters of the test tablet formulation given under fed and fasted conditions.
- Conditions
- Healthy
- Being tested
- AKB-6548 tablet, reference formulation given in the fasted state, AKB-6548 tablet, test formulation given in the fasted state., AKB-6548 tablet, test formulation given in the fed state
- Keywords
- Pharmacokinetics, Anemia, Chronic kidney disease, CKD, Renal impairment, Chronic renal insufficiency, Ferrous sulfate, Iron, End stage renal disease, Dialysis, Oral anemia treatment, Bioavailability, Erythropoietin, Hypoxia-inducible factor, Volunteers
- Medical subject headings
- Anemia, Renal Insufficiency, Chronic, Renal Insufficiency, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AKB-6548 tablet, reference formulation given in the fasted stateDrug
AKB-6548 tablet, test formulation given in the fasted state.Drug
AKB-6548 tablet, test formulation given in the fed stateDrug
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | AKB-6548 Receives: Drug: AKB-6548 tablet, reference formulation given in the fasted state |
| Treatment B | Experimental | AKB-6548 Receives: Drug: AKB-6548 tablet, test formulation given in the fasted state. |
| Treatment C | Experimental | AKB-6548 Receives: Drug: AKB-6548 tablet, test formulation given in the fed state |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioavailability endpoints: Area under the plasma concentration-time curve from 0 to last quantifiable concentration (AUC 0-t) of AKB-6548
Measured: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
Bioavailability endpoints: Area under the concentration time curve from time 0 to infinity (AUC 0-inf) of AKB-6548
Measured: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
Bioavailability endpoints: Maximum observed plasma concentration (Cmax) of AKB-6548
Measured: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
Food Effect Endpoint: AKB-6548 AUC 0-t for the fed versus fasted administration of AKB-6548 tablets
Measured: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
Food Effect Endpoint: AKB-6548 AUC 0-inf for the fed versus fasted administration of AKB-6548 tablets
Measured: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
Food Effect Endpoint: AKB-6548 Cmax for the fed versus fasted administration of AKB-6548 tablets
Measured: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
Secondary outcomes (8)
PK Parameters of AKB-6548: Maximum observed plasma concentration (Cmax)
Measured: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
PK Parameters of AKB-6548: Time to reach Cmax (Tmax)
Measured: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
PK Parameters of AKB-6548: Terminal elimination rate constant (λz)
Measured: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
PK Parameters of AKB-6548: Terminal elimination half-life (t1/2)
Measured: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
PK Parameters of AKB-6548: Area under the plasma concentration-time curve from 0 to last quantifiable concentration (AUC 0-t)
Measured: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
PK Parameters of AKB-6548: AUC from time 0 to infinity (AUC 0-inf)
Measured: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
AKB-6548: Apparent oral clearance (CL/F)
Measured: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
AKB-6548: Apparent volume of distribution during the terminal phase (Vz/F)
Measured: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2015
- Study completionApr 2015
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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 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
- NCT02412449
- Sponsor's protocol ID
- AKB-6548-CI-0013
- Status last verified
- Nov 2018
- First submitted
- 1 Apr 2015
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Single-Dose, Three-Period Crossover Study in Healthy Adults to Assess the Relative Bioavailability of Test and Reference Formulations of AKB-6548 Tablets and to Evaluate the Effect of Food on the Bioavailability of AKB-6548
- ClinicalTrials.gov ID
- NCT02412449
- Acronym / sponsor ID
- AKB-6548-CI-0013
- Conditions
- Healthy
- Keywords
- Pharmacokinetics, Anemia, Chronic kidney disease, CKD, Renal impairment, Chronic renal insufficiency, Ferrous sulfate, Iron
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Akebia TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 9 Apr 2015 (estimated)
- 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.
The primary purpose of this study is to compare the PK parameters of a single dose of a test tablet formulation of AKB-6548 relative to a single dose of the reference AKB-6548 tablet formulation, both treatments administered without food, and to compare the PK parameters of the test tablet formulation given under fed and fasted conditions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: AKB-6548 tablet, reference formulation given in the fasted stateAKB-6548 |
| Treatment B | Experimental | Drug: AKB-6548 tablet, test formulation given in the fasted state.AKB-6548 |
| Treatment C | Experimental | Drug: AKB-6548 tablet, test formulation given in the fed stateAKB-6548 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male and female subjects between 18 and 55 years of age, inclusive, and with a body mass index between 18 and 30 kg/m2, inclusive.
Key exclusion criteria (6 listed)
- Current or past history of cardiovascular, cerebrovascular, pulmonary, renal or liver disease.
- Positive serology results for HBsAg, HCV, and HIV at Screening.
- Significant renal impairment as evidenced by an estimated glomerular filtration rate (eGFR) of <65 mL/min
- Known active cancer (except non-melanoma skin cancer) or history of chemotherapy use within the previous 24 months.
- Current or past history of gastric or duodenal ulcers or other diseases of the GI tract (including gastric bypass surgeries) that could interfere with absorption of study drug.
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 |
|---|---|---|
| AKB-6548 tablet, reference formulation given in the fasted state | Drug | Treatment A |
| AKB-6548 tablet, test formulation given in the fasted state. | Drug | Treatment B |
| AKB-6548 tablet, test formulation given in the fed state | Drug | Treatment C |
Primary outcome
Bioavailability endpoints: Area under the plasma concentration-time curve from 0 to last quantifiable concentration (AUC 0-t) of AKB-6548
Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
Bioavailability endpoints: Area under the concentration time curve from time 0 to infinity (AUC 0-inf) of AKB-6548
Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
Bioavailability endpoints: Maximum observed plasma concentration (Cmax) of AKB-6548
Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
Food Effect Endpoint: AKB-6548 AUC 0-t for the fed versus fasted administration of AKB-6548 tablets
Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
Food Effect Endpoint: AKB-6548 AUC 0-inf for the fed versus fasted administration of AKB-6548 tablets
Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
Food Effect Endpoint: AKB-6548 Cmax for the fed versus fasted administration of AKB-6548 tablets
Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
8 secondary outcomes
PK Parameters of AKB-6548: Maximum observed plasma concentration (Cmax)
Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
PK Parameters of AKB-6548: Time to reach Cmax (Tmax)
Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
PK Parameters of AKB-6548: Terminal elimination rate constant (λz)
Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
PK Parameters of AKB-6548: Terminal elimination half-life (t1/2)
Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
PK Parameters of AKB-6548: Area under the plasma concentration-time curve from 0 to last quantifiable concentration (AUC 0-t)
Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
PK Parameters of AKB-6548: AUC from time 0 to infinity (AUC 0-inf)
Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
AKB-6548: Apparent oral clearance (CL/F)
Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
AKB-6548: Apparent volume of distribution during the terminal phase (Vz/F)
Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
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 14 Nov 2018.
- 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 AKB-6548 tablet, reference formulation given in the fasted state, AKB-6548 tablet, test formulation given in the fasted state. and AKB-6548 tablet, test formulation given in the fed state 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 1 inclusion and 6 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 14 Nov 2018. 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?
Bioavailability endpoints: Area under the plasma concentration-time curve from 0 to last quantifiable concentration (AUC 0-t) of AKB-6548 (time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose). The study lists 6 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 14 Nov 2018.