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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AKB-6548 (therapeutic dose)

Group Type EXPERIMENTAL

AKB-6548 (therapeutic dose)

Intervention Type DRUG

Single oral dose of AKB-6548 at a therapeutic dose level

AKB-6548 (supratherapeutic dose)

Group Type EXPERIMENTAL

AKB-6548 (supratherapeutic dose)

Intervention Type DRUG

Single oral dose of AKB-6548 at a supratherapeutic dose level

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Single oral dose of placebo

Moxifloxacin

Group Type ACTIVE_COMPARATOR

Moxifloxacin

Intervention Type DRUG

Single oral dose of 400 mg moxifloxacin

Interventions

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AKB-6548 (therapeutic dose)

Single oral dose of AKB-6548 at a therapeutic dose level

Intervention Type DRUG

AKB-6548 (supratherapeutic dose)

Single oral dose of AKB-6548 at a supratherapeutic dose level

Intervention Type DRUG

Placebo

Single oral dose of placebo

Intervention Type DRUG

Moxifloxacin

Single oral dose of 400 mg moxifloxacin

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes