Renal ImpairmentPhase 1NCT05412472

Study to Evaluate the Effects of Renal Impairment on the Pharmacokinetics, Safety and Tolerability of GC4419

A Phase 1 study testing GC4419 in people with Renal Impairment, run by Galera Therapeutics, Inc. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The study is a two-center, Phase 1, open-label, single-dose, one-period, four groups, PK study in subjects with various severities of renal impairment and matched healthy controls. Read more about this study

Who is it for?: Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Renal Impairment
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: 26 participants
Where: 2 sitesUnited States
Study dates: 4 Apr 2019to 6 Apr 2021
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 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subjects must meet all of the following criteria to be included in Arm 1:
Male or female, non-smoker ≥ 18 and ≤ 80 years of age, with BMI ≥ 18.0 and ≤ 40.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females.
Healthy as defined by the absence of clinically significant illness and surgery within 4 weeks prior to dosing; the absence of clinically significant medical history
Females of childbearing potential partner must be willing to use an acceptable contraceptive method throughout the study and for 30 days after the study drug administration:
Male subjects who are sexually active must be willing to use one of an acceptable contraceptive method from the first dosing until at least 90 days after the study drug administration:
Male subjects with a pregnant partner must agree to use a condom from the first dosing until at least 90 days after the study drug administration.

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Male subjects must be willing not to donate sperm until 90 days following study drug administration. Female subjects must avoid oocyte donation until 90 days following study drug administration.
Subjects must meet all of the following criteria to be included in Arms 2 to 4:
Male or female, non-smoker and/or light smoker, ≥18 and ≤80 years of age, with BMI ≥ 18.0 and ≤ 40.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females.
Have a diagnosis of renal impairment that has been stable, without any significant change in overall disease status in the last 3 months
Have an eGFR (MDRD4 equation) at screening within the range of:
Group 2 - Mild Group: 60 - 89 mL/min/1.73 m2;
Group 3 - Moderate Group: 30 - 59 mL/min/1.73 m2;
Group 4 - Severe Group: < 30 mL/min/1.73 m2 not requiring dialysis.
The absence of clinically unstable neurological, cardiovascular, pulmonary, hematological, psychiatric, or gastrointestinal illness
Subject may have stable treated medical illnesses and underlying diseases producing the renal impairment
Have normal or non-clinically significant findings at physical examination
Stable medical regimen deemed not to interact with study drug PK, with no changes for at least 14 days prior to dosing
Females of childbearing potential partner must be willing to use an acceptable contraceptive method throughout the study and for 30 days after the study drug administration:
Male subjects who are sexually active must be willing to use one of an acceptable contraceptive method from the first dosing until at least 90 days after the study drug administration:
Male subjects with a pregnant partner must agree to use a condom from the first dosing until at least 90 days after the study drug administration.
Male subjects must be willing not to donate sperm until 90 days following study drug administration. Female subjects must avoid oocyte donation until 90 days following study drug administration.

Who cannot join

Subjects to whom any of the following applies will be excluded from Arm 1:
Any clinically significant abnormality at physical examination or clinically significant abnormal laboratory test results at screening.
Positive test for hepatitis B, hepatitis C, or HIV at screening;
History of anaphylaxis, hypersensitivity reaction, or a clinically significant reaction to any drug.
Clinically significant ECG abnormalities or vital sign abnormalities
History of significant alcohol abuse within one year prior to screening or regular use of alcohol within six months prior to the screening visit

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History of significant drug abuse within one year prior to screening or use of soft drugs within 3 months prior to the screening visit or hard drugs within 1 year prior to screening
Participation in a clinical research study within 30 days prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing
Positive urine drug screen, alcohol breath test, or urine cotinine test at screening.
Female subject with positive pregnancy test at screening.
Breast-feeding or pregnant subject within 6 months prior to study drug administration.
Use of medication other than topical products without significant systemic absorption and hormonal contraceptives:
Prescription medication within 14 days prior to dosing;
Over-the-counter products and natural health products within 7 days prior to dosing
A depot injection or an implant of any drug within 3 months prior to dosing.
Donation of plasma within 7 days prior to dosing.
Inability to be venipunctured and/or tolerate catheter venous access.
History of myasthenia gravis or carotid sinus sensitivity.
Subjects to whom any of the following applies will be excluded from Arms 2 to 4:
Any clinically significant abnormality at physical examination or clinically significant abnormal laboratory test results found during medical screening.
Positive HIV at screening.
Female subjects with positive pregnancy test at screening.
Clinically significant unstable medical conditions or clinically significant acute exacerbation of hepatic disease within 28 days of study drug administration
Clinically significant abnormalities
Clinically significant findings on ECG
Presence of hepatocellular carcinoma or acute hepatic disease from infection or drug toxicity.
Presence of clinically active stage 3 or stage 4 hepatic encephalopathy.
Presence of surgically-created or transjugular intrahepatic portal systemic shunts.
Subjects with a positive urine drug screen or alcohol test at screening.
Systolic blood pressure lower than 90 or over 160 mmHg, diastolic blood pressure lower than 40 or over 105 mmHg, or heart rate less than 45 or over 100 bpm at screening.
History of significant drug or alcohol abuse within 6 months prior to screening.
Participation in another clinical study within 30 days prior to dosing.
Use of contraindicated medications
Donation of plasma within 7 days prior to dosing.
Breast-feeding subject.
Inability to be venipunctured and/or tolerate catheter venous access.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Inventiv Health Clinical -Research Pharmacy Unit
Miami, Florida, 33136
University of Miami Division of Clinical Pharmacology
Miami, Florida, 33136

Other trials in United States

About this study

Official title: A Phase 1, Open-Label, Single-Dose, Parallel-Group Study to Evaluate the Effects of Renal Impairment on the Pharmacokinetics, Safety and Tolerability of GC4419

The study is a two-center, Phase 1, open-label, single-dose, one-period, four groups, PK study in subjects with various severities of renal impairment and matched healthy controls.

Conditions: Renal Impairment
Being tested: GC4419
Medical subject headings: Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GC4419Drug
45 mg IV infusion of GC4419 over 60 minutes.

Study groups in NCT05412472
Study group	Role	What they receive
1) Healthy subjects with normal renal function	Experimental	Not described Receives: Drug: GC4419
2) Mild renal impairment	Experimental	Not described Receives: Drug: GC4419
3) Moderate renal impairment	Experimental	Not described Receives: Drug: GC4419
4) Severe renal impairment	Experimental	Not described Receives: Drug: GC4419

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetic (PK) profile for GC4419 (in plasma): AUC0-t
Measured: Within 1 hour before the start of infusion and 0.5, 1 (immediately before the start of the IV line flushing process), 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 36 hours after start of infusion.
Pharmacokinetic (PK) profile for GC4419 (in plasma): AUC0-inf
Measured: Within 1 hour before the start of infusion and 0.5, 1 (immediately before the start of the IV line flushing process), 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 36 hours after start of infusion.
Pharmacokinetic (PK) profile for GC4419 (in plasma): Cmax
Measured: Within 1 hour before the start of infusion and 0.5, 1 (immediately before the start of the IV line flushing process), 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 36 hours after start of infusion.
Pharmacokinetic (PK) profile for GC4419 (in plasma): Residual Area
Measured: Within 1 hour before the start of infusion and 0.5, 1 (immediately before the start of the IV line flushing process), 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 36 hours after start of infusion.
Pharmacokinetic (PK) profile for GC4419 (in plasma): Tmax
Measured: Within 1 hour before the start of infusion and 0.5, 1 (immediately before the start of the IV line flushing process), 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 36 hours after start of infusion.
Pharmacokinetic (PK) profile for GC4419 (in plasma): T1/2el
Measured: Within 1 hour before the start of infusion and 0.5, 1 (immediately before the start of the IV line flushing process), 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 36 hours after start of infusion.
Pharmacokinetic (PK) profile for GC4419 (in plasma): Kel
Measured: Within 1 hour before the start of infusion and 0.5, 1 (immediately before the start of the IV line flushing process), 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 36 hours after start of infusion.
Pharmacokinetic (PK) profile for GC4419 (in plasma): CL/F
Measured: Within 1 hour before the start of infusion and 0.5, 1 (immediately before the start of the IV line flushing process), 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 36 hours after start of infusion.
Pharmacokinetic (PK) profile for GC4419 (in plasma): Vd/F
Measured: Within 1 hour before the start of infusion and 0.5, 1 (immediately before the start of the IV line flushing process), 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 36 hours after start of infusion.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Apr 20196 Apr 2021

First posted9 Jun 2022
Study start4 Apr 2019
Primary completion30 Jan 2021
Study completion6 Apr 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Renal ImpairmentStudies 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: Parallel groups
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05412472
Sponsor's protocol ID: GTI-4419-003
Status last verified: Jun 2022
First submitted: 7 Jun 2022
Last updated: 9 Jun 2022
Results posted: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Renal Impairment trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-Label, Single-Dose, Parallel-Group Study to Evaluate the Effects of Renal Impairment on the Pharmacokinetics, Safety and Tolerability of GC4419
ClinicalTrials.gov ID: NCT05412472
Acronym / sponsor ID: GTI-4419-003
Conditions: Renal Impairment
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Galera Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 4 Apr 2019 (actual)
Primary completion: 30 Jan 2021 (actual)
Study completion: 6 Apr 2021 (actual)
First posted: 9 Jun 2022 (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 study is a two-center, Phase 1, open-label, single-dose, one-period, four groups, PK study in subjects with various severities of renal impairment and matched healthy controls.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
1) Healthy subjects with normal renal function	Experimental	Drug: GC4419
2) Mild renal impairment	Experimental	Drug: GC4419
3) Moderate renal impairment	Experimental	Drug: GC4419
4) Severe renal impairment	Experimental	Drug: GC4419

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (22 listed)

Male or female, non-smoker ≥ 18 and ≤ 80 years of age, with BMI ≥ 18.0 and ≤ 40.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females.
Healthy as defined by the absence of clinically significant illness and surgery within 4 weeks prior to dosing; the absence of clinically significant medical history
Females of childbearing potential partner must be willing to use an acceptable contraceptive method throughout the study and for 30 days after the study drug administration:
Male subjects who are sexually active must be willing to use one of an acceptable contraceptive method from the first dosing until at least 90 days after the study drug administration:
Male subjects with a pregnant partner must agree to use a condom from the first dosing until at least 90 days after the study drug administration.

Key exclusion criteria (36 listed)

Any clinically significant abnormality at physical examination or clinically significant abnormal laboratory test results at screening.
Positive test for hepatitis B, hepatitis C, or HIV at screening;
History of anaphylaxis, hypersensitivity reaction, or a clinically significant reaction to any drug.
Clinically significant ECG abnormalities or vital sign abnormalities
History of significant alcohol abuse within one year prior to screening or regular use of alcohol within six months prior to the screening visit

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
GC441945 mg IV infusion of GC4419 over 60 minutes.	Drug	1) Healthy subjects with normal renal function, 2) Mild renal impairment, 3) Moderate renal impairment, 4) Severe renal impairment

Primary outcome

Pharmacokinetic (PK) profile for GC4419 (in plasma): AUC0-t
Time frame: Within 1 hour before the start of infusion and 0.5, 1 (immediately before the start of the IV line flushing process), 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 36 hours after start of infusion.
Pharmacokinetic (PK) profile for GC4419 (in plasma): AUC0-inf
Time frame: Within 1 hour before the start of infusion and 0.5, 1 (immediately before the start of the IV line flushing process), 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 36 hours after start of infusion.
Pharmacokinetic (PK) profile for GC4419 (in plasma): Cmax
Time frame: Within 1 hour before the start of infusion and 0.5, 1 (immediately before the start of the IV line flushing process), 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 36 hours after start of infusion.
Pharmacokinetic (PK) profile for GC4419 (in plasma): Residual Area
Time frame: Within 1 hour before the start of infusion and 0.5, 1 (immediately before the start of the IV line flushing process), 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 36 hours after start of infusion.
Pharmacokinetic (PK) profile for GC4419 (in plasma): Tmax
Time frame: Within 1 hour before the start of infusion and 0.5, 1 (immediately before the start of the IV line flushing process), 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 36 hours after start of infusion.
Pharmacokinetic (PK) profile for GC4419 (in plasma): T1/2el
Time frame: Within 1 hour before the start of infusion and 0.5, 1 (immediately before the start of the IV line flushing process), 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 36 hours after start of infusion.
Pharmacokinetic (PK) profile for GC4419 (in plasma): Kel
Time frame: Within 1 hour before the start of infusion and 0.5, 1 (immediately before the start of the IV line flushing process), 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 36 hours after start of infusion.
Pharmacokinetic (PK) profile for GC4419 (in plasma): CL/F
Time frame: Within 1 hour before the start of infusion and 0.5, 1 (immediately before the start of the IV line flushing process), 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 36 hours after start of infusion.
Pharmacokinetic (PK) profile for GC4419 (in plasma): Vd/F
Time frame: Within 1 hour before the start of infusion and 0.5, 1 (immediately before the start of the IV line flushing process), 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 36 hours after start of infusion.

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 9 Jun 2022.
Individual participant dataSharing planned: No

Related trials for Renal Impairment

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
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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.

The record lists no contact. Use the official record to reach the sponsor.

2 sites 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 Renal Impairment, run by Galera Therapeutics, Inc. at 2 sites 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 22 inclusion and 36 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 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Pharmacokinetic (PK) profile for GC4419 (in plasma): AUC0-t (time frame: Within 1 hour before the start of infusion and 0.5, 1 (immediately before the start of the IV line flushing process), 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 36 hours after start of infusion.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05412472.

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 9 Jun 2022.