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

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Akebia Therapeutics
• Treatments: Fluoroquinolones; Glycine; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

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