A Study Designed to Compare the Safety and Pharmacokinetics of Intravenously Administered Superoxide Dismutase Mimetic GC4711 and GC4419 in Healthy Volunteers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03194139|
Recruitment Status : Completed
First Posted : June 21, 2017
Last Update Posted : February 14, 2018
The study will be a double-blind, randomized, crossover, single-dose assessment of IV-administered GC4711 compared to GC4419 in healthy volunteers.
Consenting subjects will undergo screening procedures within 28 days of the start of dosing. Pharmacokinetics (parent drug and major metabolites) will be assessed in plasma and urine from all subjects.
Initially, a sentinel cohort of 4 subjects, will be enrolled; each eligible subject will receive single dose of GC4711 IV at dose of 30 mg over one hour. Following a clinical safety review by the Galera study team , if no safety concerns are identified after the last subject completes study participation, enrollment will continue in 2 stages to a crossover study design. In stage 1, 12 subjects will be enrolled and in stage 2, if no safety concerns are identified in stage 1 following a clinical safety review by the Galera study team, 20 subjects will be enrolled. In both enrollment stages, eligible subjects in the crossover design will be randomized in 1:1 ratio to one of two treatment sequences: Test (GC4711) -> Ref (GC4419) or Ref (GC4419) -> Test (GC4711). On Day 1, subjects will receive the first treatment they were randomized to, and on Day 4 (following a washout), they will receive the second treatment. Subjects will be followed up for 2 days after the second treatment.
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers Healthy||Drug: GC4711 30 mg IV Drug: GC4711 50 mg IV Drug: GC4419 45 mg IV||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 1, Randomized, Double-Blind, Crossover, Single Dose Study Designed to Compare the Safety and Pharmacokinetics of Intravenously Administered Superoxide Dismutase Mimetic GC4711 and GC4419 in Healthy Volunteers|
|Actual Study Start Date :||September 25, 2017|
|Actual Primary Completion Date :||December 24, 2017|
|Actual Study Completion Date :||December 24, 2017|
|Experimental: Sentinel Cohort||
Drug: GC4711 30 mg IV
GC4711 will be infused IV as a single dose of 30 mg (3 mL GC4711 at 10 mg/mL) in 245 mL normal saline, totaling 250 mL, over a 60-minute period using a programmable pump
|Experimental: Crossover Design||
Drug: GC4711 50 mg IV
GC4711 will be infused IV as a single dose of 50 mg (5 mL GC4711 at 10 mg/mL) in 245 mL normal saline, totalling 250 mL, over a 60-minute period using a programmable pump.
Drug: GC4419 45 mg IV
GC4419 will be infused IV as a single dose of 45 mg (5 mL GC4419 at 9 mg/mL) in 245 mL normal (0.9%) saline, totalling 250 mL, over a 60-minute period using a programmable pump.
- Frequency, duration, and severity of adverse events (AEs) [ Time Frame: From first dose of study medication until up to 3 days post last dose. Up to 6 days total ]
- Incidence of clinically significant laboratory abnormalities [ Time Frame: From first dose of study medication until up to 3 days post last dose. Up to 6 days total ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03194139
|Nucleus Network Limited|
|Melbourne, Victoria, Australia, 3004|
|Study Chair:||Jon T Holmlund, MD||Galera Therapeutics|