Healthy VolunteersPhase 1NCT03099824
A Phase 1 Study of the Safety and Pharmacokinetics of GC4711 (Oral Capsule) Compared to GC4419 (IV Infusion) and GC4711 (IV Infusion) in Healthy Volunteers
A Phase 1 study testing GC4711 Oral Capsule G-101, IV GC4419 and GC4711 Oral Capsule G-111 in people with Healthy Volunteers, run by Galera Therapeutics, Inc. at 1 site in Australia.
Trial summary
The purpose of the phase 1, GTO-003 clinical study is to determine the safety and pharmacokinetics of a single dose of a new drug called GC4711 when given as an oral capsule. This study will compare capsules of GC4711 when given orally to a similar drug, GC4419, or GC4711 when either is given as an intravenous… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- GC4711 Oral Capsule G-101, IV GC4419 and GC4711 Oral Capsule G-111
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteAustralia
- Study dates
- 16 Oct 2018to 27 Jan 2020
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women between 18 and 50 years (inclusive) of age;
- Subjects who provide written informed consent
- Body Mass Index (BMI) 18 to 32 kg/m2 (inclusive) and weighing at least 50 kg during Screening and at Baseline. Every effort will be made to enroll across BMI range to evaluate relation between dose and weight;
- Subjects in general good health in the investigator's opinion
- Chest X-ray free of clinically significant abnormalities
- Blood pressure and heart rate within normal limits
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- Female subjects must:
- Have a negative serum pregnancy test during Screening and a negative urine pregnancy test at Baseline, and be willing and able to use a medically acceptable method of birth control or be postmenopausal.
- Be non-lactating
- Be at least two years postmenopausal, surgically sterile or practicing effective contraception
Who cannot join
- History of clinically significant illness, medical condition, or laboratory abnormality within three months
- History of any clinically significant cardiovascular, hepatic, renal, or gastrointestinal abnormality;
- History of hypotension
- Known contraindication, hypersensitivity and/or allergy to investigational products
- Use of any prescription or over-the-counter medication within one week prior to baseline;
- Anticipated need for any medication during the course of the study
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- Use of nitrates or erectile dysfunction drugs such as phosphodiesterase type 5 (PDE 5) inhibitors (e.g., sildenafil, tadalafil, or similar agents), from 24 hours prior to screening throughout participation in the study;
- Use of or other drugs that may, in the judgment of the treating investigator, create a risk for a precipitous decrease in blood pressure
- Presence of orthostatic hypotension at screening or baseline
- Use of any vitamin or mineral supplement 24 hours prior to dosing, or anticipated use of any vitamin or mineral supplement throughout the duration of the study;
- Positive HIV, Hepatitis B or Hepatitis C serology at Screening;
- Known history of substance abuse, drug addiction, or alcoholism within 3 years
- Anticipated inability to abstain from alcohol, tobacco, or caffeine use from 48 hours prior to the administration of study drug and throughout the duration of the study;
- Positive drug and alcohol toxicology screens during Screening and at Baseline;
- History of smoking or any use of a tobacco product within six months prior to Baseline;
- Donation of blood or blood products within 30 days prior to the Baseline and through duration of study;
- Mentally unstable or incapable of being compliant with the protocol
- Receipt of an investigational test substance within three months prior to the first dose of investigational products (GC4419, GC4711, or placebo), or anticipated receiving any investigational products (including placebo on another investigational study) other than GC4711 and GC4419 during the course of this study;
- Subject has previously participated in this study, or in a prior study of GC4419, GC4711 or GC4702.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label Study to Compare the Safety and Pharmacokinetics of Various Formulations of Orally Administered Superoxide Dismutase Mimetic GC4711 With Intravenously Administered Superoxide Dismutase Mimetic GC4419 or GC4711 in Healthy Volunteers
The purpose of the phase 1, GTO-003 clinical study is to determine the safety and pharmacokinetics of a single dose of a new drug called GC4711 when given as an oral capsule. This study will compare capsules of GC4711 when given orally to a similar drug, GC4419, or GC4711 when either is given as an intravenous infusion.
- Conditions
- Healthy Volunteers
- Being tested
- GC4711 Oral Capsule G-101, IV GC4419, GC4711 Oral Capsule G-111, GC4711 Oral Capsule G-112, GC4711 Oral Capsule G-119
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GC4711 Oral Capsule G-101Drug
82 mg (1 capsule)
IV GC4419Drug
GC4419 will be infused IV as a single dose of 27 mg in 247 mL normal saline, totaling 250 mL, over a 60-minute period using a programmable pump.
GC4711 Oral Capsule G-101Drug
164 mg (2 capsules)
GC4711 Oral Capsule G-101Drug
246 mg (3 capsules)
GC4711 Oral Capsule G-111Drug
175 mg (1 capsule)
GC4711 Oral Capsule G-112Drug
145 mg (1 capsule)
GC4711 Oral Capsule G-119Drug
233 mg (1 capsule)
GC4711 Oral Capsule G-125Drug
233 mg (1 capsule)
IV GC4711Drug
GC4711 will be infused IV as a single dose of 30 mg in 250 mL normal saline, totaling 251 mL, over a 60-minute period using a programmable pump.
| Study group | Role | What they receive |
|---|---|---|
| GC4419 IV + GC4711 Oral G-101 (82mg) | Experimental | Not described Receives: Drug: GC4711 Oral Capsule G-101; Drug: IV GC4419 |
| GC4419 IV + GC4711 Oral G-101 (164mg) | Experimental | Not described Receives: Drug: IV GC4419; Drug: GC4711 Oral Capsule G-101 |
| GC4419 IV + GC4711 Oral G-101 (246mg) | Experimental | Not described Receives: Drug: IV GC4419; Drug: GC4711 Oral Capsule G-101 |
| GC4419 IV + GC4711 Oral G-111 (175mg) | Experimental | Not described Receives: Drug: IV GC4419; Drug: GC4711 Oral Capsule G-111 |
| GC4419 IV + GC4711 Oral G-112 (145mg) | Experimental | Not described Receives: Drug: IV GC4419; Drug: GC4711 Oral Capsule G-112 |
| GC4711 IV + GC4711 Oral G-119 (233mg) | Experimental | Not described Receives: Drug: GC4711 Oral Capsule G-119; Drug: IV GC4711 |
| GC4711 IV + GC4711 Oral G-125 (233mg) | Experimental | Not described Receives: Drug: GC4711 Oral Capsule G-125; Drug: IV GC4711 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events and Laboratory Abnormalities
Number of Participants With Treatment-Emergent Adverse Events and/or Laboratory Abnormalities.
Measured: From randomization through study completion (estimated up to 13 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start16 Oct 2018
- Primary completion27 Jan 2020
- Study completion27 Jan 2020
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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galera Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jon T Holmlund, MD, Study chair, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03099824
- Sponsor's protocol ID
- GTO-003
- Status last verified
- Mar 2021
- First submitted
- 20 Mar 2017
- Last updated
- 2 Mar 2021
- Results posted
- 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 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Study to Compare the Safety and Pharmacokinetics of Various Formulations of Orally Administered Superoxide Dismutase Mimetic GC4711 With Intravenously Administered Superoxide Dismutase Mimetic GC4419 or GC4711 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03099824
- Acronym / sponsor ID
- GTO-003
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Galera Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 27 Jan 2020 (actual)
- Study completion
- 27 Jan 2020 (actual)
- First posted
- 4 Apr 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.
The purpose of the phase 1, GTO-003 clinical study is to determine the safety and pharmacokinetics of a single dose of a new drug called GC4711 when given as an oral capsule. This study will compare capsules of GC4711 when given orally to a similar drug, GC4419, or GC4711 when either is given as an intravenous infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| GC4419 IV + GC4711 Oral G-101 (82mg) | Experimental | Drug: GC4711 Oral Capsule G-101, Drug: IV GC4419 |
| GC4419 IV + GC4711 Oral G-101 (164mg) | Experimental | Drug: IV GC4419, Drug: GC4711 Oral Capsule G-101 |
| GC4419 IV + GC4711 Oral G-101 (246mg) | Experimental | Drug: IV GC4419, Drug: GC4711 Oral Capsule G-101 |
| GC4419 IV + GC4711 Oral G-111 (175mg) | Experimental | Drug: IV GC4419, Drug: GC4711 Oral Capsule G-111 |
| GC4419 IV + GC4711 Oral G-112 (145mg) | Experimental | Drug: IV GC4419, Drug: GC4711 Oral Capsule G-112 |
| GC4711 IV + GC4711 Oral G-119 (233mg) | Experimental | Drug: GC4711 Oral Capsule G-119, Drug: IV GC4711 |
| GC4711 IV + GC4711 Oral G-125 (233mg) | Experimental | Drug: GC4711 Oral Capsule G-125, Drug: IV GC4711 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Healthy men and women between 18 and 50 years (inclusive) of age;
- Subjects who provide written informed consent
- Body Mass Index (BMI) 18 to 32 kg/m2 (inclusive) and weighing at least 50 kg during Screening and at Baseline. Every effort will be made to enroll across BMI range to evaluate relation between dose and weight;
- Subjects in general good health in the investigator's opinion
- Chest X-ray free of clinically significant abnormalities
Key exclusion criteria (19 listed)
- History of clinically significant illness, medical condition, or laboratory abnormality within three months
- History of any clinically significant cardiovascular, hepatic, renal, or gastrointestinal abnormality;
- History of hypotension
- Known contraindication, hypersensitivity and/or allergy to investigational products
- Use of any prescription or over-the-counter medication within one week prior to baseline;
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 |
|---|---|---|
| GC4711 Oral Capsule G-10182 mg (1 capsule) | Drug | GC4419 IV + GC4711 Oral G-101 (82mg) |
| IV GC4419GC4419 will be infused IV as a single dose of 27 mg in 247 mL normal saline, totaling 250 mL, over a 60-minute period using a programmable pump. | Drug | GC4419 IV + GC4711 Oral G-101 (164mg), GC4419 IV + GC4711 Oral G-101 (246mg), GC4419 IV + GC4711 Oral G-101 (82mg), GC4419 IV + GC4711 Oral G-111 (175mg), GC4419 IV + GC4711 Oral G-112 (145mg) |
| GC4711 Oral Capsule G-101164 mg (2 capsules) | Drug | GC4419 IV + GC4711 Oral G-101 (164mg) |
| GC4711 Oral Capsule G-101246 mg (3 capsules) | Drug | GC4419 IV + GC4711 Oral G-101 (246mg) |
| GC4711 Oral Capsule G-111175 mg (1 capsule) | Drug | GC4419 IV + GC4711 Oral G-111 (175mg) |
| GC4711 Oral Capsule G-112145 mg (1 capsule) | Drug | GC4419 IV + GC4711 Oral G-112 (145mg) |
| GC4711 Oral Capsule G-119233 mg (1 capsule) | Drug | GC4711 IV + GC4711 Oral G-119 (233mg) |
| GC4711 Oral Capsule G-125233 mg (1 capsule) | Drug | GC4711 IV + GC4711 Oral G-125 (233mg) |
| IV GC4711GC4711 will be infused IV as a single dose of 30 mg in 250 mL normal saline, totaling 251 mL, over a 60-minute period using a programmable pump. | Drug | GC4711 IV + GC4711 Oral G-119 (233mg), GC4711 IV + GC4711 Oral G-125 (233mg) |
Primary outcome
Incidence of Treatment-Emergent Adverse Events and Laboratory Abnormalities
Time frame: From randomization through study completion (estimated up to 13 days)
Number of Participants With Treatment-Emergent Adverse Events and/or Laboratory Abnormalities.
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 2 Mar 2021.
- 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
Chief Medical Officer
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 GC4711 Oral Capsule G-101, IV GC4419 and GC4711 Oral Capsule G-111 in people with Healthy Volunteers, 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 10 inclusion and 19 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 2 Mar 2021. 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. 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?
Incidence of Treatment-Emergent Adverse Events and Laboratory Abnormalities (time frame: From randomization through study completion (estimated up to 13 days)). 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 2 Mar 2021.