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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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03099824
Recruitment Status : Recruiting
First Posted : April 4, 2017
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
Galera Therapeutics, Inc.

Brief Summary:
The purpose of the phase 1, GTO-003 clinical study is to determine the safety and pharmacokinetics of a single dose of a new drug called GC4711 when given as an oral capsule. This study will compare capsules of GC4711 when given orally to a similar drug, GC4419, or GC4711 when either is given as an intravenous infusion.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: GC4711 Oral Capsule G-101 Drug: IV GC4419 Drug: GC4711 Oral Capsule G-111 Drug: GC4711 Oral Capsule G-112 Drug: GC4711 Oral Capsule G-119 Drug: GC4711 Oral Capsule G-125 Drug: IV GC4711 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : October 16, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: GC4419 IV + GC4711 Oral G-101 (82mg) Drug: GC4711 Oral Capsule G-101
82 mg (1 capsule)

Drug: 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.

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

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

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

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

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

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

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

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

Experimental: GC4711 IV + GC4711 Oral G-119 (233mg) Drug: GC4711 Oral Capsule G-119
233 mg (1 capsule)

Drug: 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.

Experimental: GC4711 IV + GC4711 Oral G-125 (233mg) Drug: GC4711 Oral Capsule G-125
233 mg (1 capsule)

Drug: 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.




Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events and Laboratory Abnormalities [ Time Frame: From randomization through study completion (estimated up to 13 days) ]
    Number of Participants With Treatment-Emergent Adverse Events and/or Laboratory Abnormalities.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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.

Information from the National Library of Medicine

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): NCT03099824


Contacts
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Contact: Kara T Terry, MD (610)725-1500 kterry@galeratx.com

Locations
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Australia
Nucleus Network Recruiting
Melbourne, Australia
Contact: Kara Terry         
Sponsors and Collaborators
Galera Therapeutics, Inc.
Investigators
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Study Chair: Jon T Holmlund, MD Chief Medical Officer
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Responsible Party: Galera Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03099824    
Other Study ID Numbers: GTO-003
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes