Healthy VolunteersPhase 1NCT03163173
A Study to Investigate the Absorption, Metabolism, Excretion, and Mass Balance of GC4419 in Healthy Adult Subjects
A Phase 1 study testing GC4419 in people with Healthy Volunteers and Healthy, run by Galera Therapeutics, Inc. at 1 site in United States.
Trial summary
GC4419 is being studied to treat and prevent oral mucositis (painful inflammation) in cancer patients who receive radiation and chemotherapy. In this study, GC4419 will be mixed with a small amount of radioactive material in order to find out how much study drug is in the blood and to see how the drug is processed and… Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Healthy
- What is being tested?
- GC4419
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 14 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 19 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, adult, male, 19-55 years of age, inclusive, at screening.
- Continuous non-smoker who has not used nicotine containing products for at least 3 months prior to dosing and throughout the study.
- Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2 at screening.
- No clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs
- A non-vasectomized subject must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days beyond dosing.
- Must agree not to donate sperm from dosing until 90 days after dosing.
- Be willing and able to comply with the protocol.
Who cannot join
- Subject is mentally or legally incapacitated
- History or presence of clinically significant medical or psychiatric condition or disease
- History or presence of alcoholism or drug abuse within the past 2 years prior to dosing.
- History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds.
- Regularly has less than 1 bowel movement every 2 days.
- Recent history (within 2 weeks of Day 1) of abnormal bowel habits
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- Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
- Blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg
- Heart rate is lower than 40 bpm or higher than 99 bpm
- Unable to refrain from or anticipates the use of any drug, including prescription and non prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to dosing and throughout the study.
- Has been on a diet incompatible with the on study diet
- Donation of blood or significant blood loss within 56 days prior to dosing.
- Plasma donation within 7 days prior to dosing.
- Has received radiolabeled substances or has been exposed to radiation sources over the past 12 months or is likely to receive radiation exposure or radioisotopes within the next 12 months such that participation in this study would increase their total exposure beyond the recommended levels considered safe
- Participation in another clinical study within 28 days prior to dosing.
Trial locations and contacts
1 site in 1 country.
About this study
GC4419 is being studied to treat and prevent oral mucositis (painful inflammation) in cancer patients who receive radiation and chemotherapy.
In this study, GC4419 will be mixed with a small amount of radioactive material in order to find out how much study drug is in the blood and to see how the drug is processed and eliminated from the body. The safety and how subjects tolerate the study drug will also be studied.
Read the detailed description
This is an open-label, single-dose, 1-period study.
On Day 1, a single 30 mg (~100 μCi) dose of [14C]GC4419 will be administered as an IV infusion over 15 minutes. Blood, urine, and fecal samples will be collected to measure total radioactivity (plasma, whole blood, urine, and fecal samples), for GC4419 and its metabolites GC4520 and GC4570 concentrations (plasma, urine, and fecal samples), and for metabolic profiling (plasma, urine, and fecal samples), as total amounts of radioactivity allow, for at least 168 hours postdose (Day 8).
If discharge criteria are not met on Day 8, collection of blood will be collected approximately every 72 hours, and urine and feces collection will continue in 24-hour intervals thereafter (for determination of total radioactivity and metabolic profiling only) until the discharge criteria are met or up to a maximum stay of 28 days (Day 29).
The clinic will attempt to contact all subjects (including subjects who terminate the study early) using their standard procedures approximately 14 days after the last sample collection to determine if any adverse event has occurred since the last sample collection.
Six (6), healthy, adult, non tobacco using, male subjects will be enrolled.
- Conditions
- Healthy Volunteers, Healthy
- Being tested
- GC4419
- Keywords
- Healthy Adult, Superoxide Dismutase, Absorption, Metabolism, Elimination, Mass Balance, Male Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GC4419Drug
30 mg (~100 μCi) dose of [14C]GC4419
| Study group | Role | What they receive |
|---|---|---|
| Single Arm - Treatment Group | Experimental | 30 mg (~100 μCi) dose of [14C]GC4419 administered as an IV infusion over 15 minutes on Day 1 following an overnight fast Receives: Drug: GC4419 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mass balance of GC4419
Total radioactivity found in biological specimens
Measured: From dosing until discharge criteria are met [up to a maximum stay of 28 days postdose (Day 29)]
Total radioactivity in plasma (AUC0-t)
The area under the concentration time or concentration equivalent time curve, from time 0 to the last observed non-zero concentration (Ct)
Measured: From dosing until discharge criteria are met [up to a maximum stay of 28 days postdose (Day 29)]
Major metabolites in biological specimens.
Total concentrations of GC4419 and its metabolites found in biological specimens
Measured: From dosing until discharge criteria are met [up to a maximum stay of 28 days postdose (Day 29)]
14C radioactivity in whole blood
Change over time in percentage of 14C radioactivity in whole blood
Measured: From dosing until discharge criteria are met [up to a maximum stay of 28 days postdose (Day 29)]
Total radioactivity in plasma (Cmax)
Maximum observed concentration or concentration equivalent
Measured: From dosing until discharge criteria are met [up to a maximum stay of 28 days postdose (Day 29)]
Total radioactivity in plasma (Tmax)
Time to reach Cmax
Measured: From dosing until discharge criteria are met [up to a maximum stay of 28 days postdose (Day 29)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start14 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galera Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Responsible party
- Sponsor
- Investigators
- Jon T Holmlund, MD, Study chair, Galera Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03163173
- Sponsor's protocol ID
- GTI-4419-001
- Status last verified
- May 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 Study to Investigate the Absorption, Metabolism, Excretion, and Mass Balance of GC4419 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT03163173
- Acronym / sponsor ID
- GTI-4419-001
- Conditions
- Healthy Volunteers, Healthy
- Keywords
- Healthy Adult, Superoxide Dismutase, Absorption, Metabolism, Elimination, Mass Balance, Male Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Galera Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Study start
- 14 Aug 2017 (actual)
- Primary completion
- 13 Oct 2017 (actual)
- Study completion
- 13 Oct 2017 (actual)
- First posted
- 22 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.
GC4419 is being studied to treat and prevent oral mucositis (painful inflammation) in cancer patients who receive radiation and chemotherapy.
In this study, GC4419 will be mixed with a small amount of radioactive material in order to find out how much study drug is in the blood and to see how the drug is processed and eliminated from the body. The safety and how subjects tolerate the study drug will also be studied.
Detailed description
This is an open-label, single-dose, 1-period study.
On Day 1, a single 30 mg (~100 μCi) dose of [14C]GC4419 will be administered as an IV infusion over 15 minutes. Blood, urine, and fecal samples will be collected to measure total radioactivity (plasma, whole blood, urine, and fecal samples), for GC4419 and its metabolites GC4520 and GC4570 concentrations (plasma, urine, and fecal samples), and for metabolic profiling (plasma, urine, and fecal samples), as total amounts of radioactivity allow, for at least 168 hours postdose (Day 8).
If discharge criteria are not met on Day 8, collection of blood will be collected approximately every 72 hours, and urine and feces collection will continue in 24-hour intervals thereafter (for determination of total radioactivity and metabolic profiling only) until the discharge criteria are met or up to a maximum stay of 28 days (Day 29).
The clinic will attempt to contact all subjects (including subjects who terminate the study early) using their standard procedures approximately 14 days after the last sample collection to determine if any adverse event has occurred since the last sample collection.
Six (6), healthy, adult, non tobacco using, male subjects will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm - Treatment Group | Experimental | Drug: GC441930 mg (~100 μCi) dose of [14C]GC4419 administered as an IV infusion over 15 minutes on Day 1 following an overnight fast |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy, adult, male, 19-55 years of age, inclusive, at screening.
- Continuous non-smoker who has not used nicotine containing products for at least 3 months prior to dosing and throughout the study.
- Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2 at screening.
- No clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs
- A non-vasectomized subject must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days beyond dosing.
Key exclusion criteria (15 listed)
- Subject is mentally or legally incapacitated
- History or presence of clinically significant medical or psychiatric condition or disease
- History or presence of alcoholism or drug abuse within the past 2 years prior to dosing.
- History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds.
- Regularly has less than 1 bowel movement every 2 days.
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 |
|---|---|---|
| GC441930 mg (~100 μCi) dose of [14C]GC4419 | Drug | Single Arm - Treatment Group |
Primary outcome
Mass balance of GC4419
Time frame: From dosing until discharge criteria are met [up to a maximum stay of 28 days postdose (Day 29)]
Total radioactivity found in biological specimens
Total radioactivity in plasma (AUC0-t)
Time frame: From dosing until discharge criteria are met [up to a maximum stay of 28 days postdose (Day 29)]
The area under the concentration time or concentration equivalent time curve, from time 0 to the last observed non-zero concentration (Ct)
Major metabolites in biological specimens.
Time frame: From dosing until discharge criteria are met [up to a maximum stay of 28 days postdose (Day 29)]
Total concentrations of GC4419 and its metabolites found in biological specimens
14C radioactivity in whole blood
Time frame: From dosing until discharge criteria are met [up to a maximum stay of 28 days postdose (Day 29)]
Change over time in percentage of 14C radioactivity in whole blood
Total radioactivity in plasma (Cmax)
Time frame: From dosing until discharge criteria are met [up to a maximum stay of 28 days postdose (Day 29)]
Maximum observed concentration or concentration equivalent
Total radioactivity in plasma (Tmax)
Time frame: From dosing until discharge criteria are met [up to a maximum stay of 28 days postdose (Day 29)]
Time to reach Cmax
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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Screening Protocol
Pain
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 in people with Healthy Volunteers and Healthy, run by Galera Therapeutics, Inc. at 1 site in United States.
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 7 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 United States. 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?
Mass balance of GC4419 (time frame: From dosing until discharge criteria are met [up to a maximum stay of 28 days postdose (Day 29)]). The study lists 6 primary outcomes in all. 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.