- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03164109
A Phase 1, Randomized, Placebo-and Positive-Controlled Crossover Study to Determine the Effect of Single-Dose GC4419 on QTc Interval in Healthy Volunteers
This is a partially double-blind study in healthy adult subjects, which will be conducted as a placebo- and active-controlled, single-dose, crossover study.
Twenty-eight subjects will be enrolled to ensure 24 subjects on all study periods. All subjects will receive all 3 study treatments (GC4419, placebo and moxifloxacin) in randomized sequence.
Cardiodynamic assessment using continuous ECG recordings (Holters) will be performed for approximately 26 hours on the day of dosing (Day 1) in each study period. ECGs will be extracted serially pre- and post-dose and predefined timepoints at which subjects will be supinely resting.
Subjects will be supinely resting for at least 10 minutes prior to and 5 minutes after each nominal timepoint for ECG extraction.
Blood draws for PK will be performed in all periods at the same timepoints and always after ECG extraction.
Subjects will be domiciled in the clinic from noon/afternoon of the day before dosing (Day -1) until completion of safety procedures on Day 2 in each study period.
All subjects (including subjects who terminate the study early) will return to the clinical research unit (CRU) 14 (± 1) days after the last administration of study treatment for follow-up procedures and to determine if any Adverse Event (AE) has occurred since the last study visit.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Victoria
-
Melbourne, Victoria, Australia, 3004
- Nucleus Network Limited
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy, adult, male or female, 18-55 years of age
- Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dose.
- Must weigh at least 60 kg for males or 52 kg for females and have a body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or ECGs
- For a female of childbearing potential: either be sexually inactive as a voluntary lifestyle choice for at least 1 year prior to first dosing until 21 days following last dosing or be using an acceptable birth control method
- For a female of non-childbearing potential: must have undergone an acceptable sterilization procedure or be postmenopausal for at least 1 year prior to the first dose
- Willing and able to comply with the protocol.
- Seated blood pressure between 90/40 mmHg and 140/90 mmHg
- Has serum potassium, calcium, and magnesium levels within the normal range at screening.
Exclusion Criteria:
- History or presence of clinically significant medical or psychiatric condition, disease or illness
- History or presence of alcoholism or drug abuse within the past 2 years
- History or presence of hypersensitivity to the study drugs
- History of significant multiple and/or severe allergies
- Female subjects who are pregnant or lactating.
- Positive results at screening for human immunodeficiency virus (HIV), syphilis, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
- Unable to refrain from or anticipates the use of any drug, including prescription and non-prescription medications 14 days prior to the first dose of study drug and throughout the study.
- Any drugs known to be significant inhibitors or inducers of CYP enzymes and/or P-gp, including St. John's Wort, for 28 days prior to the first dose of study drug and throughout the study.
- Has been on a diet incompatible with the on-study diet, within the 28 days prior to the first dose of study drug, and throughout the study.
- Donation of blood or significant blood loss within 56 days
- Plasma donation within 7 days prior to the first dose of study drug.
- Has had surgery or any medical condition which may affect the absorption, distribution, metabolism, or elimination of the study drug within 6 months.
- Participation in another clinical trial within 28 days
- Participation in a previous clinical trial where subject received GC4419.
- History or presence of: hypokalemia, risk factors for Torsades de Pointes , sick sinus syndrome, second, or third degree atrioventricular block, myocardial infarction, pulmonary congestion, cardiac arrhythmia, prolonged QT interval, or conduction abnormalities; repeated or frequent syncope or vasovagal episodes; hypertension, angina, bradycardia, or severe peripheral arterial circulatory disorders.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Infused IV over 15 minutes
|
Experimental: GC4419 IV
|
50mg infused IV over 15 minutes
|
Active Comparator: Oral moxifloxacin
|
400 mg tablet orally with 250 mL room temperature water
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in QT interval corrected for heart rate using the Fridericia formula (QTcF)
Time Frame: From 45 minute pre-dose to 24 hours post dose
|
From 45 minute pre-dose to 24 hours post dose
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Jon T Holmlund, MD, Galera Therapeutics
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GTI-4419-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
-
King's College LondonUniversity of ReadingCompletedHealthy | Healthy AgingUnited Kingdom
Clinical Trials on GC4419 IV
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Completed
-
Galera Therapeutics, Inc.CompletedRenal ImpairmentUnited States
-
Galera Therapeutics, Inc.CompletedRadiation Induced Oral MucositisUnited States, Canada, Puerto Rico
-
Galera Therapeutics, Inc.INC Research Australia Pty Ltd; Nucleous NetworkCompletedHealthy VolunteerAustralia
-
Galera Therapeutics, Inc.CelerionCompletedHealthy | Healthy VolunteersUnited States
-
Galera Therapeutics, Inc.TerminatedCovid19 | SARS-CoV-2 InfectionUnited States
-
Galera Therapeutics, Inc.Terminated
-
Taipei City HospitalNot yet recruitingAcute Flank PainTaiwan
-
Healthgen Biotechnology Corp.RecruitingEmphysema Secondary to Congenital AATDUnited States