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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03099824




Registration number
NCT03099824
Ethics application status
Date submitted
20/03/2017
Date registered
4/04/2017

Titles & IDs
Public title
A Phase 1 Study of the Safety and Pharmacokinetics of GC4711 (Oral Capsule) Compared to GC4419 (IV Infusion) and GC4711 (IV Infusion) in Healthy Volunteers
Scientific title
A Phase 1, Open-label Study to Compare the Safety and Pharmacokinetics of Various Formulations of Orally Administered Superoxide Dismutase Mimetic GC4711 With Intravenously Administered Superoxide Dismutase Mimetic GC4419 or GC4711 in Healthy Volunteers
Secondary ID [1] 0 0
GTO-003
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GC4711 Oral Capsule G-101
Treatment: Drugs - IV GC4419
Treatment: Drugs - GC4711 Oral Capsule G-101
Treatment: Drugs - GC4711 Oral Capsule G-101
Treatment: Drugs - GC4711 Oral Capsule G-111
Treatment: Drugs - GC4711 Oral Capsule G-112
Treatment: Drugs - GC4711 Oral Capsule G-119
Treatment: Drugs - GC4711 Oral Capsule G-125
Treatment: Drugs - IV GC4711

Experimental: GC4419 IV + GC4711 Oral G-101 (82mg) -

Experimental: GC4419 IV + GC4711 Oral G-101 (164mg) -

Experimental: GC4419 IV + GC4711 Oral G-101 (246mg) -

Experimental: GC4419 IV + GC4711 Oral G-111 (175mg) -

Experimental: GC4419 IV + GC4711 Oral G-112 (145mg) -

Experimental: GC4711 IV + GC4711 Oral G-119 (233mg) -

Experimental: GC4711 IV + GC4711 Oral G-125 (233mg) -


Treatment: Drugs: GC4711 Oral Capsule G-101
82 mg (1 capsule)

Treatment: Drugs: IV GC4419
GC4419 will be infused IV as a single dose of 27 mg in 247 mL normal saline, totaling 250 mL, over a 60-minute period using a programmable pump.

Treatment: Drugs: GC4711 Oral Capsule G-101
164 mg (2 capsules)

Treatment: Drugs: GC4711 Oral Capsule G-101
246 mg (3 capsules)

Treatment: Drugs: GC4711 Oral Capsule G-111
175 mg (1 capsule)

Treatment: Drugs: GC4711 Oral Capsule G-112
145 mg (1 capsule)

Treatment: Drugs: GC4711 Oral Capsule G-119
233 mg (1 capsule)

Treatment: Drugs: GC4711 Oral Capsule G-125
233 mg (1 capsule)

Treatment: Drugs: IV GC4711
GC4711 will be infused IV as a single dose of 30 mg in 250 mL normal saline, totaling 251 mL, over a 60-minute period using a programmable pump.
Intervention code [1] 0 0
Treatment: Drugs
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 study completion (estimated up to 13 days)

Eligibility
Key inclusion criteria
1. Healthy men and women between 18 and 50 years (inclusive) of age;
2. Subjects who provide written informed consent
3. Body Mass Index (BMI) 18 to 32 kg/m2 (inclusive) and weighing at least 50 kg during Screening and at Baseline. Every effort will be made to enroll across BMI range to evaluate relation between dose and weight;
4. Subjects in general good health in the investigator's opinion
5. Chest X-ray free of clinically significant abnormalities
6. Blood pressure and heart rate within normal limits
7. Female subjects must:

1. Have a negative serum pregnancy test during Screening and a negative urine pregnancy test at Baseline, and be willing and able to use a medically acceptable method of birth control or be postmenopausal.
2. Be non-lactating
3. Be at least two years postmenopausal, surgically sterile or practicing effective contraception
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History of clinically significant illness, medical condition, or laboratory abnormality within three months
2. History of any clinically significant cardiovascular, hepatic, renal, or gastrointestinal abnormality;
3. History of hypotension
4. Known contraindication, hypersensitivity and/or allergy to investigational products
5. Use of any prescription or over-the-counter medication within one week prior to baseline;
6. Anticipated need for any medication during the course of the study
7. Use of nitrates or erectile dysfunction drugs such as phosphodiesterase type 5 (PDE 5) inhibitors (e.g., sildenafil, tadalafil, or similar agents), from 24 hours prior to screening throughout participation in the study;
8. Use of or other drugs that may, in the judgment of the treating investigator, create a risk for a precipitous decrease in blood pressure
9. Presence of orthostatic hypotension at screening or baseline
10. 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;
11. Positive HIV, Hepatitis B or Hepatitis C serology at Screening;
12. Known history of substance abuse, drug addiction, or alcoholism within 3 years
13. Anticipated inability to abstain from alcohol, tobacco, or caffeine use from 48 hours prior to the administration of study drug and throughout the duration of the study;
14. Positive drug and alcohol toxicology screens during Screening and at Baseline;
15. History of smoking or any use of a tobacco product within six months prior to Baseline;
16. Donation of blood or blood products within 30 days prior to the Baseline and through duration of study;
17. Mentally unstable or incapable of being compliant with the protocol
18. Receipt of an investigational test substance within three months prior to the first dose of investigational products (GC4419, GC4711, or placebo), or anticipated receiving any investigational products (including placebo on another investigational study) other than GC4711 and GC4419 during the course of this study;
19. Subject has previously participated in this study, or in a prior study of GC4419, GC4711 or GC4702.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



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
16/10/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/01/2020
Sample size
Target
Accrual to date
Final
56
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Galera Therapeutics, Inc.
Address
Country

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
Chief Medical Officer
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/NCT03099824