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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03164109




Registration number
NCT03164109
Ethics application status
Date submitted
15/05/2017
Date registered
23/05/2017
Date last updated
17/11/2017

Titles & IDs
Public title
A Phase 1, Randomized, Placebo-and Positive-Controlled Crossover Study to Determine the Effect of Single-Dose GC4419 on QTc Interval in Healthy Volunteers
Scientific title
A Phase 1, Randomized, Placebo-and Positive-Controlled Crossover Study to Determine the Effect of Single-Dose GC4419 on QTc Interval in Healthy Volunteers
Secondary ID [1] 0 0
GTI-4419-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GC4419 IV
Treatment: Drugs - Placebo
Treatment: Drugs - Oral moxifloxacin

Experimental: GC4419 IV -

Placebo Comparator: Placebo -

Active Comparator: Oral moxifloxacin -


Treatment: Drugs: GC4419 IV
50mg infused IV over 15 minutes

Treatment: Drugs: Placebo
Infused IV over 15 minutes

Treatment: Drugs: Oral moxifloxacin
400 mg tablet orally with 250 mL room temperature water

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in QT interval corrected for heart rate using the Fridericia formula (QTcF)
Timepoint [1] 0 0
From 45 minute pre-dose to 24 hours post dose

Eligibility
Key inclusion criteria
1. Healthy, adult, male or female, 18-55 years of age

2. Continuous non-smoker who has not used nicotine-containing products for at least 3
months prior to the first dose.

3. 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

4. Medically healthy with no clinically significant medical history, physical
examination, laboratory profiles, vital signs, or ECGs

5. 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

6. 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

7. Willing and able to comply with the protocol.

8. Seated blood pressure between 90/40 mmHg and 140/90 mmHg

9. Has serum potassium, calcium, and magnesium levels within the normal range at
screening.
Minimum age
18 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History or presence of clinically significant medical or psychiatric condition,
disease or illness

2. History or presence of alcoholism or drug abuse within the past 2 years

3. History or presence of hypersensitivity to the study drugs

4. History of significant multiple and/or severe allergies

5. Female subjects who are pregnant or lactating.

6. Positive results at screening for human immunodeficiency virus (HIV), syphilis,
hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).

7. 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.

8. 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.

9. 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.

10. Donation of blood or significant blood loss within 56 days

11. Plasma donation within 7 days prior to the first dose of study drug.

12. Has had surgery or any medical condition which may affect the absorption,
distribution, metabolism, or elimination of the study drug within 6 months.

13. Participation in another clinical trial within 28 days

14. Participation in a previous clinical trial where subject received GC4419.

15. 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network Limited - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Galera Therapeutics, Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Syneos Health
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03164109
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jon T Holmlund, MD
Address 0 0
Galera Therapeutics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications