A Phase 1 interventional study of AKB-6548 (therapeutic dose) and AKB-6548 (supratherapeutic dose) in Healthy Volunteers, sponsored by Akebia Therapeutics. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-14.
Sponsored by Akebia Therapeutics · Phase 1, Interventional, and Other
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.
1,768 studies on the registry are indexed under Anemia; 244 are open to participants now.
This study's enrollment of 50 is below the median of 96 across 1,318 interventional studies indexed under Anemia.
Browse Anemia studies →Akebia Therapeutics is the lead sponsor of 37 studies on the registry; 3 are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 12 (55%) have results posted.
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Key Inclusion Criteria:
Key Exclusion Criteria:
Drug: AKB-6548 (therapeutic dose)
Drug: AKB-6548 (supratherapeutic dose)
Drug: Placebo
Drug: Moxifloxacin
Single oral dose of AKB-6548 at a therapeutic dose level
Single oral dose of AKB-6548 at a supratherapeutic dose level
Single oral dose of placebo
Single oral dose of 400 mg moxifloxacin
Placebo-corrected change-from-baseline QTcF (ΔΔQTcF) following AKB-6548 administration.
Time frame: multiple timepoint evaluations from pre-dose to 24 hours post-dose
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
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Vadadustat