ClinicalTrials.Veeva

Menu

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

Akebia Therapeutics logo

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems