Healthy Volunteers
Conditions
Keywords
Akebia, QT interval, TQT, pharmacokinetic, anemia, chronic kidney disease, CKD, chronic renal insufficiency, renal impairment, safety
Brief 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.
Interventions
DRUGAKB-6548 (therapeutic dose)
Single oral dose of AKB-6548 at a therapeutic dose level
DRUGAKB-6548 (supratherapeutic dose)
Single oral dose of AKB-6548 at a supratherapeutic dose level
DRUGPlacebo
Single oral dose of placebo
DRUGMoxifloxacin
Single oral dose of 400 mg moxifloxacin
Sponsors
Akebia Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * 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
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Placebo-corrected change-from-baseline QTcF (ΔΔQTcF) following AKB-6548 administration. | multiple timepoint evaluations from pre-dose to 24 hours post-dose |
Secondary
| Measure | Time frame |
|---|---|
| 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 | multiple timepoint evaluations from pre-dose to 24 hours post-dose |
| Categorical outliers for HR, PR interval, QRS interval | multiple timepoint evaluations from pre-dose to 24 hours post-dose |
| Placebo-corrected change-from-baseline heart rate (HR), PR interval, QRS interval | multiple timepoint evaluations from pre-dose to 24 hours post-dose |
| Placebo-corrected change-from-baseline QTcF (ΔΔQTcF) following moxifloxacin administration | 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 | from first dose of study medication through the final protocol required visit |
| Frequency of T wave morphology changes | multiple timepoint evaluations from pre-dose to 24 hours post-dose |
Countries
United States
Outcome results
None listed