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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
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
Secondary ID [1] 0 0
GTO-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Treatment-Emergent Adverse Events and Laboratory Abnormalities
Timepoint [1] 0 0
From randomization through 4 days post last dosing in Active Phase of each cohort.

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.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/07/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2016
Sample size
Target
Accrual to date
Final
48
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network Limited - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Galera Therapeutics, Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
INC Research Australia Pty Ltd
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Nucleous Network
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jon T Holmlund, MD
Address 0 0
Galera Therapeutics, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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