Healthy VolunteersPhase 1NCT02062203
Effect of AKB-6548 on Cardiac Repolarization Intervals in Healthy Volunteers
A Phase 1 study testing AKB-6548 (therapeutic dose), AKB-6548 (supratherapeutic dose) and Moxifloxacin in people with Healthy Volunteers, run by Akebia Therapeutics at 1 site in United States.
Trial summary
The main purpose of this study is to evaluate the effect of single oral therapeutic and supratherapeutic doses of AKB-6548 on the QT interval. 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?
- AKB-6548 (therapeutic dose), AKB-6548 (supratherapeutic dose) and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Apr 2014
- 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, non-smoking males or females, 18 and 55 years of age, inclusive
- BMI 18.0 and 32.0 kg/m2, inclusive
- non clinically significant 12-lead ECG
- heart rate of 45 to 90 beats per minute, inclusive
- mean systolic blood pressure <141 mmHg and mean diastolic blood pressure < 90 mmHg
Who cannot join
- history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, GI, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
- history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias, or torsades de pointes, structural heart disease, or a family history of Long QT syndrome
- significant abnormalities in liver function tests
- history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
- history of Gilbert's Syndrome
- positive hepatitis panel
- seizure disorder or receiving anti-epilepsy medication for seizure disorder
- any acute or chronic condition that, in the opinion of the Investigator, may pose a safety risk to a subject in this study or which would limit the subject's ability to complete and/or participate in this clinical study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Single-Center, Partially Double-Blinded, Active and Placebo Controlled, Randomized 4-Way Crossover Study to Evaluate the Effect of AKB-6548 on Cardiac Repolarization Intervals in Healthy Volunteers
The main purpose of this study is to evaluate the effect of single oral therapeutic and supratherapeutic doses of AKB-6548 on the QT interval.
- Conditions
- Healthy Volunteers
- Being tested
- AKB-6548 (therapeutic dose), AKB-6548 (supratherapeutic dose), Placebo, Moxifloxacin
- Keywords
- Akebia, QT interval, TQT, pharmacokinetic, anemia, chronic kidney disease, CKD, chronic renal insufficiency, renal impairment, safety
- Medical subject headings
- Anemia, Renal Insufficiency, Chronic, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AKB-6548 (therapeutic dose)Drug
Single oral dose of AKB-6548 at a therapeutic dose level
AKB-6548 (supratherapeutic dose)Drug
Single oral dose of AKB-6548 at a supratherapeutic dose level
PlaceboDrug
Single oral dose of placebo
MoxifloxacinDrug
Single oral dose of 400 mg moxifloxacin
| Study group | Role | What they receive |
|---|---|---|
| AKB-6548 (therapeutic dose) | Experimental | Not described Receives: Drug: AKB-6548 (therapeutic dose) |
| AKB-6548 (supratherapeutic dose) | Experimental | Not described Receives: Drug: AKB-6548 (supratherapeutic dose) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Moxifloxacin | Active comparator | Not described Receives: Drug: Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Placebo-corrected change-from-baseline QTcF (ΔΔQTcF) following AKB-6548 administration.
Measured: multiple timepoint evaluations from pre-dose to 24 hours post-dose
Secondary outcomes (6)
Placebo-corrected change-from-baseline heart rate (HR), PR interval, QRS interval
Measured: multiple timepoint evaluations from pre-dose to 24 hours post-dose
Categorical outliers defined as QTcF >450 msec, 480 msec and 500 msec at any timepoint and change-from-baseline QTcF (ΔQTcF) >30 msec (increased by 30 msec) and >60 msec
Measured: multiple timepoint evaluations from pre-dose to 24 hours post-dose
Categorical outliers for HR, PR interval, QRS interval
Measured: multiple timepoint evaluations from pre-dose to 24 hours post-dose
Frequency of T wave morphology changes
Measured: multiple timepoint evaluations from pre-dose to 24 hours post-dose
Placebo-corrected change-from-baseline QTcF (ΔΔQTcF) following moxifloxacin administration
Measured: multiple timepoint evaluations from pre-dose to 24 hours post-dose
Safety parameters to include adverse events; changes in routine clinical laboratory measures including chemistry, hematology, and urinalysis; and clinically significant changes noted during physical examinations or in vital signs
Measured: from first dose of study medication through the final protocol required visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionApr 2014
- Study completionApr 2014
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 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
- NCT02062203
- Sponsor's protocol ID
- AKB-6548-CI-0010
- Status last verified
- Nov 2018
- First submitted
- 11 Feb 2014
- 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 Phase 1, Single-Center, Partially Double-Blinded, Active and Placebo Controlled, Randomized 4-Way Crossover Study to Evaluate the Effect of AKB-6548 on Cardiac Repolarization Intervals in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02062203
- Acronym / sponsor ID
- AKB-6548-CI-0010
- Conditions
- Healthy Volunteers
- Keywords
- Akebia, QT interval, TQT, pharmacokinetic, anemia, chronic kidney disease, CKD, chronic renal insufficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Akebia TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 13 Feb 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 main purpose of this study is to evaluate the effect of single oral therapeutic and supratherapeutic doses of AKB-6548 on the QT interval.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AKB-6548 (therapeutic dose) | Experimental | Drug: AKB-6548 (therapeutic dose) |
| AKB-6548 (supratherapeutic dose) | Experimental | Drug: AKB-6548 (supratherapeutic dose) |
| Placebo | Placebo comparator | Drug: Placebo |
| Moxifloxacin | Active comparator | Drug: Moxifloxacin |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy, non-smoking males or females, 18 and 55 years of age, inclusive
- BMI 18.0 and 32.0 kg/m2, inclusive
- non clinically significant 12-lead ECG
- heart rate of 45 to 90 beats per minute, inclusive
- mean systolic blood pressure <141 mmHg and mean diastolic blood pressure < 90 mmHg
Key exclusion criteria (8 listed)
- history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, GI, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
- history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias, or torsades de pointes, structural heart disease, or a family history of Long QT syndrome
- significant abnormalities in liver function tests
- history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
- history of Gilbert's Syndrome
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 (therapeutic dose)Single oral dose of AKB-6548 at a therapeutic dose level | Drug | AKB-6548 (therapeutic dose) |
| AKB-6548 (supratherapeutic dose)Single oral dose of AKB-6548 at a supratherapeutic dose level | Drug | AKB-6548 (supratherapeutic dose) |
| PlaceboSingle oral dose of placebo | Drug | Placebo |
| MoxifloxacinSingle oral dose of 400 mg moxifloxacin | Drug | Moxifloxacin |
Primary outcome
Placebo-corrected change-from-baseline QTcF (ΔΔQTcF) following AKB-6548 administration.
Time frame: multiple timepoint evaluations from pre-dose to 24 hours post-dose
6 secondary outcomes
Placebo-corrected change-from-baseline heart rate (HR), PR interval, QRS interval
Time frame: multiple timepoint evaluations from pre-dose to 24 hours post-dose
Categorical outliers defined as QTcF >450 msec, 480 msec and 500 msec at any timepoint and change-from-baseline QTcF (ΔQTcF) >30 msec (increased by 30 msec) and >60 msec
Time frame: multiple timepoint evaluations from pre-dose to 24 hours post-dose
Categorical outliers for HR, PR interval, QRS interval
Time frame: multiple timepoint evaluations from pre-dose to 24 hours post-dose
Frequency of T wave morphology changes
Time frame: multiple timepoint evaluations from pre-dose to 24 hours post-dose
Placebo-corrected change-from-baseline QTcF (ΔΔQTcF) following moxifloxacin administration
Time frame: multiple timepoint evaluations from pre-dose to 24 hours post-dose
Safety parameters to include adverse events; changes in routine clinical laboratory measures including chemistry, hematology, and urinalysis; and clinically significant changes noted during physical examinations or in vital signs
Time frame: from first dose of study medication through the final protocol required visit
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
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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 (therapeutic dose), AKB-6548 (supratherapeutic dose) and Moxifloxacin 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 5 inclusion and 8 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. Some participants in this study may receive a placebo. 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?
Placebo-corrected change-from-baseline QTcF (ΔΔQTcF) following AKB-6548 administration. (time frame: multiple timepoint evaluations from pre-dose to 24 hours post-dose). 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.