NCT02537288

Brief Summary

The purpose of this study is to assess the electrocardiogram (ECG) effects of fedovapagon dose administration relative to placebo in healthy adult male and female subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Oct 2015

Shorter than P25 for phase_1 healthy

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

First Submitted

Initial submission to the registry

August 5, 2015

Completed
27 days until next milestone

First Posted

Study publicly available on registry

September 1, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 6, 2016

Status Verified

January 1, 2016

Enrollment Period

2 months

First QC Date

August 5, 2015

Last Update Submit

January 5, 2016

Conditions

Healthy

Keywords

VA106483fedovapagonmalesfemalesmoxifloxacinTQTQT/QTCECGNocturia

Outcome Measures

Primary Outcomes (1)

  • Time-matched change from baseline in QTc, placebo-adjusted and corrected for heart rate

    0-48 hours

Secondary Outcomes (11)

  • Heart rate

    0-48 hours

  • PR interval

    0-48 hours

  • QRS interval

    0-48 hours

  • Uncorrected QT interval

    0-48 hours

  • ECG morphology especially on repolarization

    0-48 hours

  • +6 more secondary outcomes

Study Arms (4)

Placebo matched to fedovapagon

EXPERIMENTAL

One dose of placebo (matched to fedovapagon)

Drug: Placebo (for fedovapagon)

Fedovapagon 2 mg

EXPERIMENTAL

One dose of 2 mg fedovapagon

Drug: Fedovapagon

Fedovapagon 20 mg

EXPERIMENTAL

One dose of 20 mg fedovapagon

Drug: Fedovapagon

Moxifloxacin 400 mg (open label)

EXPERIMENTAL

One dose of moxifloxacin 400 mg (open label)

Drug: Moxifloxacin

Interventions

FedovapagonDRUG
Fedovapagon 2 mgFedovapagon 20 mg
MoxifloxacinDRUG
Moxifloxacin 400 mg (open label)
Placebo (for fedovapagon)DRUG
Placebo matched to fedovapagon

Eligibility Criteria

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

You may qualify if:

  • Provide signed and dated informed consent before any study-specific procedures are conducted.
  • Healthy males and females 18 to 55 years of age (inclusive).
  • No clinically significant abnormal physical findings.
  • No clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening or admission.
  • Have a body mass index (BMI) ≥18.0 to ≤29.9 kg/m2 (weight: ≥50 kg and ≤100 kg) at the Screening visit.
  • Be judged by the Investigator to be in good health based on medical history, physical examination, vital sign measurements and laboratory safety tests performed at the Screening visit and before the first administration of fedovapagon, moxifloxacin or placebo.
  • Have no clinically significant abnormality on an ECG performed at the Screening visit and on admission to the study center.
  • Have a normal resting blood pressure.
  • Must be able to understand and be willing to comply with study procedures, restrictions and requirements.
  • Agree to refrain from the consumption of grapefruit or grapefruit juice beginning 1 week prior to administration of the initial administration fedovapagon, moxifloxacin or placebo, throughout the trial.
  • Agree to refrain from the consumption of alcohol and/or methylxanthines e.g., caffeine (coffee, tea and cola) beginning 96 hours prior to administration of the initial administration of fedovapagon, moxifloxacin or placebo, throughout the trial.
  • Current non-smokers who have not used any nicotine-containing products (chewed or smoked) or replacement products including electronic cigarettes in the 45 days prior to screening.
  • Woman of child-bearing potential must be using effective methods (failure rate \<1%) of birth control at least 4 weeks prior to Screening until 4 weeks after the administration of fedovapagon, moxifloxacin or placebo.
  • Male subjects should be willing to use a condom with spermicide during sexual activity with female partners of child-bearing potential and must not donate sperm. Female sexual partners of male subjects should be willing to avoid pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PAREXEL Early Phase Clinical Unit Berlin

Berlin, 14050, Germany

Location

MeSH Terms

Conditions

Nocturia

Interventions

Moxifloxacin

Condition Hierarchy (Ancestors)

Lower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Georg Golor, PD Dr med

    Parexel

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 5, 2015

First Posted

September 1, 2015

Study Start

October 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 6, 2016

Record last verified: 2016-01

Locations

DE(1)