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
Overview
- Phase
- Phase 1
- Intervention
- GC4419
- Conditions
- Renal Impairment
- Sponsor
- Galera Therapeutics, Inc.
- Enrollment
- 26
- Locations
- 2
- Primary Endpoint
- Pharmacokinetic (PK) profile for GC4419 (in plasma): Residual Area
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •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
- •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.
Arms & Interventions
3) Moderate renal impairment
Intervention: GC4419
1) Healthy subjects with normal renal function
Intervention: GC4419
2) Mild renal impairment
Intervention: GC4419
4) Severe renal impairment
Intervention: GC4419
Outcomes
Primary Outcomes
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): 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): 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): 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): 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): 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.
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): 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.