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Completed

NCT Number: NCT02062203

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

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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Key information

Conditions

Healthy Volunteers Anemia Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Evansville, Indiana, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AKB-6548 (therapeutic dose)

Drug

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

AKB-6548 (supratherapeutic dose)

Drug

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

Placebo

Drug

Single oral dose of placebo

moxifloxacin

Drug

Single oral dose of 400 mg moxifloxacin

Primary outcomes

  1. Placebo-corrected change-from-baseline QTcF (ΔΔQTcF) following AKB-6548 administration.

    Time frame: multiple timepoint evaluations from pre-dose to 24 hours post-dose

Secondary outcomes

  1. 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

  2. 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

  3. Categorical outliers for HR, PR interval, QRS interval

    Time frame: multiple timepoint evaluations from pre-dose to 24 hours post-dose

  4. Frequency of T wave morphology changes

    Time frame: multiple timepoint evaluations from pre-dose to 24 hours post-dose

  5. Placebo-corrected change-from-baseline QTcF (ΔΔQTcF) following moxifloxacin administration

    Time frame: multiple timepoint evaluations from pre-dose to 24 hours post-dose

  6. 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

Sponsors and collaborators

Lead sponsor

Akebia Therapeutics

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 13, 2014
Registry last updated
Nov 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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