Effect of AKB-6548 on Cardiac Repolarization Intervals in Healthy Volunteers

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02062203
• Other study ID #: AKB-6548-CI-0010
• Status: Completed
• Phase: Phase 1
• Start date: January 2014
• Est. completion date: April 2014

Study information

• Verified date: November 2018
• Source: Akebia Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• AKB-6548 (therapeutic dose)
Single oral dose of AKB-6548 at a therapeutic dose level
• AKB-6548 (supratherapeutic dose)
Single oral dose of AKB-6548 at a supratherapeutic dose level
• Placebo
Single oral dose of placebo
• Moxifloxacin
Single oral dose of 400 mg moxifloxacin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Akebia Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Placebo-corrected change-from-baseline QTcF (??QTcF) following AKB-6548 administration.		multiple timepoint evaluations from pre-dose to 24 hours post-dose
Secondary	Placebo-corrected change-from-baseline heart rate (HR), PR interval, QRS interval		multiple timepoint evaluations from pre-dose to 24 hours post-dose
Secondary	Categorical outliers defined as QTcF >450 msec, 480 msec and 500 msec at any timepoint and change-from-baseline QTcF (?QTcF) >30 msec (increased by 30 msec) and >60 msec		multiple timepoint evaluations from pre-dose to 24 hours post-dose
Secondary	Categorical outliers for HR, PR interval, QRS interval		multiple timepoint evaluations from pre-dose to 24 hours post-dose
Secondary	Frequency of T wave morphology changes		multiple timepoint evaluations from pre-dose to 24 hours post-dose
Secondary	Placebo-corrected change-from-baseline QTcF (??QTcF) following moxifloxacin administration		multiple timepoint evaluations from pre-dose to 24 hours post-dose
Secondary	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