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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03096756
Registration number
NCT03096756
Ethics application status
Date submitted
24/03/2017
Date registered
30/03/2017
Titles & IDs
Public title
A Study of the Safety, Tolerability and Pharmacokinetics of Orally-administered GC4702 in Healthy Volunteers
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Scientific title
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study Designed to Compare the Safety and Pharmacokinetics of Orally Administered Superoxide Dismutase Mimetic GC4702 With Intravenously Administered Superoxide Dismutase Mimetic GC4419 (Part 1), With Assessment of Food Effect (Part 2), in Healthy Volunteers
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Secondary ID [1]
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GTO-001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteer
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - GC4702 dry powder
Treatment: Drugs - GC4702 lipid suspension
Other interventions - GC4419 IV
Other interventions - Placebo Dry Powder
Other interventions - Placebo lipid suspension
Other interventions - Fed Condition
Other interventions - Fasting Condition
Treatment: Drugs - GC4702 lipid suspension - Part 2
Other: Part 1: Single Ascending Dose Escalation GC4702 - Serially increase dose escalation of orally formulated GC4702 or placebo (6:2 ratio), preceded by single dose of active comparator, GC4419 IV.
Experimental: Part 2: Food Effect Study - Following Part 1 dose find, single dose level of GC4702 administered under fasting for and fed condition.
Treatment: Drugs: GC4702 dry powder
5 mg GC4702 mixed with approximately 270 mg of Prosolv 90 LM - SMCC (siliconized microcrystalline cellulose). Planned dose levels of GC4702 encapsulated dry powder formulation are 50, 100, and 150 mg
Treatment: Drugs: GC4702 lipid suspension
112 mg GC4702 mixed with Miglyol 812 plus 0.5% by weight BHA plus 1% by weight of Aerosil 200. Planned dose levels of GC4702 encapsulated lipid suspension formulation are 112, 224, and 336, 448, and 560 mg
Other interventions: GC4419 IV
infused IV as a single dose of 27 mg (3 mL GC4419 at 9 mg/mL) in 247 mL normal (0.9%) saline, totaling 250 mL, over a 60minute period using a programmable pump.
Other interventions: Placebo Dry Powder
Product matches appearance of the GC4702 dry powder formulation. The Placebo will be 500 mg Miglyol 812 oil containing up to 1% of colloidal silicon dioxide in size 1 capsule.
Other interventions: Placebo lipid suspension
Product matches appearance of the GC4702 lipid suspension formulation. The Placebo will be 500 mg Miglyol 812 oil containing up to 1% of colloidal silicon dioxide in size 1 capsule.
Other interventions: Fed Condition
with 240 mL (8 fluid ounces) of tap water following a high calorie/high fat meal. Subjects assigned to the fed condition will receive a standard meal per U.S. FDA guidelines7 consisting of high calorie/high fat meal prior to dosing consisting of total calories of 800-1000 of which 150, 250 and 500-600 calories are from protein, carbohydrate and fat, respectively.
Other interventions: Fasting Condition
For the fasting condition, GC4702 will be administered following an overnight fast of at least 10 hours, with 240 mL (8 fluid ounces) of water. No food will be allowed for at least 4 hours post-dose. Water will be allowed as desired except for one hour before and after drug administration.
Treatment: Drugs: GC4702 lipid suspension - Part 2
Two single doses of GC4702 (dose level to be selected based on Part 1 results), separated by a 7-day washout period
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of Treatment-Emergent Adverse Events and Laboratory Abnormalities
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Assessment method [1]
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Number of Participants With Treatment-Emergent Adverse Events and/or Laboratory Abnormalities.
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Timepoint [1]
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From randomization through 4 days post last dosing in Active Phase of each cohort.
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Eligibility
Key inclusion criteria
1. Healthy men and women, age 18 and 50 years
2. Body Mass Index (BMI) 18 to 32 kg/m2, and weighing at least 50 kg at screening.
3. Blood pressure and heart rate within normal limits
4. Non-lactating, non-pregnant female, confirmed by urine pregnancy screening and willing to use acceptable methods of birth control, per medical and institutional practice.
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Minimum age
18
Years
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Maximum age
50
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
1. History of any chronic disease; or significant medical condition within three months, including but not limited to human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C
2. Use of any prescription or over-the-counter medication within one week prior to baseline
3. Anticipated need for any medication during the course of the study, with the exception of contraceptive and hormone replacement therapy
4. Use of any medications that at risk for causing a precipitous decrease in blood pressure, (e.g., nitrates or erectile dysfunction drugs, from 24 hours prior to screening and throughout participation in the study)
5. Use of any vitamin or mineral supplement 24 hours prior to dosing, or anticipated use of any vitamin or mineral supplement throughout the duration of the study;
6. History of substance abuse, drug addiction, or alcoholism within 3 years prior to Baseline and/or the inability to abstain from alcohol, or drug use from 48 hours prior to the administration of study drug and throughout the duration of the study as confirmed by toxicology screens during Screening and at Baseline
7. History of smoking or any use of a tobacco product within six months prior to Baseline and/or the inability to abstain from tobacco or caffeine use from 48 hours prior to the administration of study drug and throughout the duration of the study.
8. Donation of blood or blood products within 30 days prior to the Baseline
9. Subject has previously participated in this study.
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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
26/07/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2016
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Sample size
Target
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Accrual to date
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Final
48
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Nucleus Network Limited - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Galera Therapeutics, Inc.
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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INC Research Australia Pty Ltd
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Nucleous Network
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
A Phase 1 study will test the safety, tolerability and pharmacokinetics of a single dose of GC4702 when given as an oral tablet. This study will compare capsules containing a dry powder or gel suspension of GC4702 when given orally to a similar drug called GC4419 which will be given as an intravenous infusion. This study will also assess the effect of food on the GC4702 effects.
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Trial website
https://clinicaltrials.gov/study/NCT03096756
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Trial related presentations / publications
Squillace S, Salvemini D. Nitroxidative stress in pain and opioid-induced adverse effects: therapeutic opportunities. Pain. 2022 Feb 1;163(2):205-213. doi: 10.1097/j.pain.0000000000002347. No abstract available.
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Public notes
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Contacts
Principal investigator
Name
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Jon T Holmlund, MD
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Address
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Galera Therapeutics, Inc.
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03096756