NCT02062203

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 11, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 13, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

November 14, 2018

Status Verified

November 1, 2018

Enrollment Period

3 months

First QC Date

February 11, 2014

Last Update Submit

November 10, 2018

Conditions

Healthy Volunteers

Keywords

AkebiaQT intervalTQTpharmacokineticanemiachronic kidney diseaseCKDchronic renal insufficiencyrenal impairmentsafety

Outcome Measures

Primary Outcomes (1)

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

    multiple timepoint evaluations from pre-dose to 24 hours post-dose

Secondary Outcomes (6)

  • Placebo-corrected change-from-baseline heart rate (HR), PR interval, QRS interval

    multiple timepoint evaluations from pre-dose to 24 hours post-dose

  • 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

    multiple timepoint evaluations from pre-dose to 24 hours post-dose

  • Categorical outliers for HR, PR interval, QRS interval

    multiple timepoint evaluations from pre-dose to 24 hours post-dose

  • Frequency of T wave morphology changes

    multiple timepoint evaluations from pre-dose to 24 hours post-dose

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

    multiple timepoint evaluations from pre-dose to 24 hours post-dose

  • +1 more secondary outcomes

Study Arms (4)

AKB-6548 (therapeutic dose)

EXPERIMENTAL
Drug: AKB-6548 (therapeutic dose)

AKB-6548 (supratherapeutic dose)

EXPERIMENTAL
Drug: AKB-6548 (supratherapeutic dose)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Moxifloxacin

ACTIVE COMPARATOR
Drug: Moxifloxacin

Interventions

AKB-6548 (therapeutic dose)DRUG

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

AKB-6548 (therapeutic dose)
AKB-6548 (supratherapeutic dose)DRUG

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

AKB-6548 (supratherapeutic dose)
PlaceboDRUG

Single oral dose of placebo

Placebo
MoxifloxacinDRUG

Single oral dose of 400 mg moxifloxacin

Moxifloxacin

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Evansville, Indiana, United States

Location

MeSH Terms

Conditions

AnemiaRenal Insufficiency, ChronicRenal Insufficiency

Interventions

vadadustatMoxifloxacin

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Akebia Therapeutics

    Sponsor GmbH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2014

First Posted

February 13, 2014

Study Start

January 1, 2014

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

November 14, 2018

Record last verified: 2018-11

Locations

US(1)