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

Akebia Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: AKB-6548 (supratherapeutic dose); Drug: Moxifloxacin; Drug: AKB-6548 (therapeutic dose); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02062203

AKB-6548-CI-0010

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

50 participants in 4 patient groups, including a placebo group

AKB-6548 (therapeutic dose)

Experimental group

Treatment:

Drug: AKB-6548 (therapeutic dose)

AKB-6548 (supratherapeutic dose)

Experimental group

Treatment:

Drug: AKB-6548 (supratherapeutic dose)

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Moxifloxacin

Active Comparator group

Treatment:

Drug: Moxifloxacin