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

Phase 1

Completed

• Conditions: Renal Impairment
• Interventions: Drug: GC4419

• Registration Number: NCT05412472
• Lead Sponsor: Galera Therapeutics, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-04
• Primary Completion: 2021-01-30
• Study Completion: 2021-04-06
• Status Verified: 2022-06
• Study First Submitted: 2022-06-07
• Study First Submitted QC: 2022-06-07
• Last Update Submitted: 2022-06-07
• Study First Posted: 2022-06-09
• Last Update Posted: 2022-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Not provided

Exclusion Criteria

Subjects to whom any of the following applies will be excluded from Arm 1:

1. Any clinically significant abnormality at physical examination or clinically significant abnormal laboratory test results at screening.

2. Positive test for hepatitis B, hepatitis C, or HIV at screening;

3. History of anaphylaxis, hypersensitivity reaction, or a clinically significant reaction to any drug.

4. Clinically significant ECG abnormalities or vital sign abnormalities

5. History of significant alcohol abuse within one year prior to screening or regular use of alcohol within six months prior to the screening visit

6. 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

7. 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

8. Positive urine drug screen, alcohol breath test, or urine cotinine test at screening.

9. Female subject with positive pregnancy test at screening.

10. Breast-feeding or pregnant subject within 6 months prior to study drug administration.

11. Use of medication other than topical products without significant systemic absorption and hormonal contraceptives:

    1. Prescription medication within 14 days prior to dosing;
    2. Over-the-counter products and natural health products within 7 days prior to dosing
    3. A depot injection or an implant of any drug within 3 months prior to dosing.

12. Donation of plasma within 7 days prior to dosing.

13. Inability to be venipunctured and/or tolerate catheter venous access.

14. History of myasthenia gravis or carotid sinus sensitivity.

Subjects to whom any of the following applies will be excluded from Arms 2 to 4:

1. Any clinically significant abnormality at physical examination or clinically significant abnormal laboratory test results found during medical screening.
2. Positive HIV at screening.
3. Female subjects with positive pregnancy test at screening.
4. Clinically significant unstable medical conditions or clinically significant acute exacerbation of hepatic disease within 28 days of study drug administration
5. Clinically significant abnormalities
6. Clinically significant findings on ECG
7. Presence of hepatocellular carcinoma or acute hepatic disease from infection or drug toxicity.
8. Presence of clinically active stage 3 or stage 4 hepatic encephalopathy.
9. Presence of surgically-created or transjugular intrahepatic portal systemic shunts.
10. Subjects with a positive urine drug screen or alcohol test at screening.
11. 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.
12. History of significant drug or alcohol abuse within 6 months prior to screening.
13. Participation in another clinical study within 30 days prior to dosing.
14. Use of contraindicated medications
15. Donation of plasma within 7 days prior to dosing.
16. Breast-feeding subject.
17. Inability to be venipunctured and/or tolerate catheter venous access.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1) Healthy subjects with normal renal function	GC4419	-
2) Mild renal impairment	GC4419	-
3) Moderate renal impairment	GC4419	-
4) Severe renal impairment	GC4419	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic (PK) profile for GC4419 (in plasma): AUC0-t	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	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	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	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	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	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	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	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	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.

Trial Locations

Locations (2)

Inventiv Health Clinical -Research Pharmacy Unit; 🇺🇸 Miami, Florida, United States

University of Miami Division of Clinical Pharmacology; 🇺🇸 Miami, Florida, United States