Healthy VolunteersPhase 1NCT03164109
A Phase 1, Randomized, Placebo-and Positive-Controlled Crossover Study to Determine the Effect of Single-Dose GC4419 on QTc Interval in Healthy Volunteers
A Phase 1 study testing GC4419 IV and Oral moxifloxacin in people with Healthy Volunteers and Healthy, run by Galera Therapeutics, Inc. at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Healthy
- What is being tested?
- GC4419 IV and Oral moxifloxacin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteAustralia
- Study dates
- 18 Aug 2017to 13 Oct 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Healthy Volunteers, Healthy
- Being tested
- GC4419 IV, Placebo, Oral moxifloxacin
- Keywords
- Healthy Adult, Superoxide Dismutase, Free Radical Dismutase, Cardiodynamic Assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GC4419 IVDrug
50mg infused IV over 15 minutes
PlaceboDrug
Infused IV over 15 minutes
Oral moxifloxacinDrug
400 mg tablet orally with 250 mL room temperature water
| Study group | Role | What they receive |
|---|---|---|
| GC4419 IV | Experimental | Not described Receives: Drug: GC4419 IV |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Oral moxifloxacin | Active comparator | Not described Receives: Drug: Oral moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in QT interval corrected for heart rate using the Fridericia formula (QTcF)
Measured: From 45 minute pre-dose to 24 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2017
- Study start18 Aug 2017
- Primary completion13 Oct 2017
- Study completion13 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galera Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Responsible party
- Sponsor
- Investigators
- Jon T Holmlund, MD, Study chair, Galera Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03164109
- Sponsor's protocol ID
- GTI-4419-002
- Status last verified
- Nov 2017
- First submitted
- 15 May 2017
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03164109
- Acronym / sponsor ID
- GTI-4419-002
- Conditions
- Healthy Volunteers, Healthy
- Keywords
- Healthy Adult, Superoxide Dismutase, Free Radical Dismutase, Cardiodynamic Assessment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Galera Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Study start
- 18 Aug 2017 (actual)
- Primary completion
- 13 Oct 2017 (actual)
- Study completion
- 13 Oct 2017 (actual)
- First posted
- 23 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GC4419 IV | Experimental | Drug: GC4419 IV |
| Placebo | Placebo comparator | Drug: Placebo |
| Oral moxifloxacin | Active comparator | Drug: Oral moxifloxacin |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GC4419 IV50mg infused IV over 15 minutes | Drug | GC4419 IV |
| PlaceboInfused IV over 15 minutes | Drug | Placebo |
| Oral moxifloxacin400 mg tablet orally with 250 mL room temperature water | Drug | Oral moxifloxacin |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jon T Holmlund, MD study chair
Galera Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GC4419 IV and Oral moxifloxacin in people with Healthy Volunteers and Healthy, run by Galera Therapeutics, Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017.