Healthy VolunteersPhase 1NCT02327546
Effects of Ferrous Sulfate on the Pharmacokinetics of AKB-6548
A Phase 1 study testing AKB-6548 and Ferrous Sulfate in people with Healthy Volunteers, run by Akebia Therapeutics at 1 site in United States.
Trial summary
The primary purpose of this study is to assess the single-dose bioavailability of AKB-6548 with ferrous sulfate relative to AKB-6548 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- AKB-6548 and Ferrous Sulfate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Feb 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects 18 to 55 years of age with a body mass index between 18 and 30 kg/m2
- Participants and their partners must use a highly effective form of contraception during the study and for 1 month following discharge from the Clinical Research Unit (CRU)
- Subjects must discontinue all iron preparations for 14 days prior to study drug administration
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
- Renal impairment (estimated glomerular filtration rate (eGFR) of <65mL/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: An Open-Label, Randomized, Single-Dose Study to Evaluate the Effects of 325 mg Ferrous Sulfate Tablet (65 mg Iron) on the Pharmacokinetics of 450 mg Dose of AKB-6548 in Healthy Male Volunteers.
The primary purpose of this study is to assess the single-dose bioavailability of AKB-6548 with ferrous sulfate relative to AKB-6548 in healthy volunteers.
- Conditions
- Healthy Volunteers
- Being tested
- AKB-6548, Ferrous Sulfate
- Keywords
- Pharmacokinetics, Anemia, Chronic kidney disease, CKD, Chronic renal insufficiency, Renal impairment, Ferrous sulfate, Iron, Drug-drug interaction, End stage renal disease, Dialysis, Erythropoietin, Oral anemia treatment, Hypoxia-induciable factor, HIF, Hypoxia-induciable factor prolyl-hydroxylase inhibitor, HIF-PHI
- 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-6548Drug
Ferrous SulfateDrug
| Study group | Role | What they receive |
|---|---|---|
| AKB-6548 | Experimental | AKB-6548 Receives: Drug: AKB-6548 |
| AKB-6548 plus Ferrous Sulfate | Experimental | AKB-6548 plus ferrous sulfate Receives: Drug: AKB-6548; Drug: Ferrous Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK parameters of AKB-6548: Maximum plasma concentration (Cmax)
Measured: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
PK parameters of AKB-6548: Area under the curve from time 0 until the last quantifiable concentration (AUC [last])
Measured: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
PK parameters of AKB-6548: Area under the concentration-time curve from 0 to infinity (AUCinf)
Measured: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
Secondary outcomes (14)
PK parameters of AKB-6548: Time to maximum plasma concentration (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: Plasma half life (t1/2)
Measured: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
PK parameters of AKB-6548: Apparent total systemic clearance (CL/F)
Measured: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
PK parameters of AKB-6548: Apparent volume of distribution during the terminal elimination phase (VzF)
Measured: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
PK parameters of AKB-6548 metabolites: Maximum plasma concentration (Cmax)
Measured: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
PK parameters of AKB-6548 metabolites: Time to maximum plasma concentration (Tmax)
Measured: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
PK parameters of AKB-6548 metabolites: Terminal elimination rate constant (λz)
Measured: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
PK parameters of AKB-6548 metabolites: Plasma half life (t1/2)
Measured: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
PK parameters of AKB-6548 metabolites: Area under the curve from time 0 until the last quantifiable concentration (AUC [last])
Measured: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
PK parameters of AKB-6548 metabolites: Area under the concentration-time curve from 0 to infinity (AUCinf)
Measured: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
Ratio of metabolite to parent drug for maximum plasma concentration (Cmax)
Measured: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
Ratio of metabolite to parent drug for are under the curve from time 0 until the last quantifiable concentration (AUC [last])
Measured: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
Ratio of metabolite to parent drug for area under the concentration-time curve (AUC)
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 posted30 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2014
- Study completionFeb 2015
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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 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
- NCT02327546
- Sponsor's protocol ID
- AKB-6548-CI-0012
- Status last verified
- Nov 2018
- First submitted
- 23 Dec 2014
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
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
- An Open-Label, Randomized, Single-Dose Study to Evaluate the Effects of 325 mg Ferrous Sulfate Tablet (65 mg Iron) on the Pharmacokinetics of 450 mg Dose of AKB-6548 in Healthy Male Volunteers.
- ClinicalTrials.gov ID
- NCT02327546
- Acronym / sponsor ID
- AKB-6548-CI-0012
- Conditions
- Healthy Volunteers
- Keywords
- Pharmacokinetics, Anemia, Chronic kidney disease, CKD, Chronic renal insufficiency, Renal impairment, Ferrous sulfate, Iron
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Akebia TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 30 Dec 2014 (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 assess the single-dose bioavailability of AKB-6548 with ferrous sulfate relative to AKB-6548 in healthy volunteers.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AKB-6548 | Experimental | Drug: AKB-6548AKB-6548 |
| AKB-6548 plus Ferrous Sulfate | Experimental | Drug: AKB-6548, Drug: Ferrous SulfateAKB-6548 plus ferrous sulfate |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male subjects 18 to 55 years of age with a body mass index between 18 and 30 kg/m2
- Participants and their partners must use a highly effective form of contraception during the study and for 1 month following discharge from the Clinical Research Unit (CRU)
- Subjects must discontinue all iron preparations for 14 days prior to study drug administration
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
- Renal impairment (estimated glomerular filtration rate (eGFR) of <65mL/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 | Drug | AKB-6548, AKB-6548 plus Ferrous Sulfate |
| Ferrous Sulfate | Drug | AKB-6548 plus Ferrous Sulfate |
Primary outcome
PK parameters of AKB-6548: Maximum plasma concentration (Cmax)
Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
PK parameters of AKB-6548: Area under the curve from time 0 until the last quantifiable concentration (AUC [last])
Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
PK parameters of AKB-6548: Area under the concentration-time curve from 0 to infinity (AUCinf)
Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
14 secondary outcomes
PK parameters of AKB-6548: Time to maximum plasma concentration (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: Plasma half life (t1/2)
Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
PK parameters of AKB-6548: Apparent total systemic clearance (CL/F)
Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
PK parameters of AKB-6548: Apparent volume of distribution during the terminal elimination phase (VzF)
Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
PK parameters of AKB-6548 metabolites: Maximum plasma concentration (Cmax)
Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
PK parameters of AKB-6548 metabolites: Time to maximum plasma concentration (Tmax)
Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
PK parameters of AKB-6548 metabolites: Terminal elimination rate constant (λz)
Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
PK parameters of AKB-6548 metabolites: Plasma half life (t1/2)
Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
PK parameters of AKB-6548 metabolites: Area under the curve from time 0 until the last quantifiable concentration (AUC [last])
Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
PK parameters of AKB-6548 metabolites: Area under the concentration-time curve from 0 to infinity (AUCinf)
Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
Ratio of metabolite to parent drug for maximum plasma concentration (Cmax)
Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
Ratio of metabolite to parent drug for are under the curve from time 0 until the last quantifiable concentration (AUC [last])
Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose
Ratio of metabolite to parent drug for area under the concentration-time curve (AUC)
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.
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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 and Ferrous Sulfate in people with Healthy Volunteers, 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 3 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?
PK parameters of AKB-6548: Maximum plasma concentration (Cmax) (time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose). 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 14 Nov 2018.