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A Study of the Safety, Tolerability and Pharmacokinetics of Orally-administered GC4702 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: NCT03096756
Recruitment Status : Completed
First Posted : March 30, 2017
Last Update Posted : April 4, 2017
Sponsor:
Collaborators:
INC Research Australia Pty Ltd
Nucleous Network
Information provided by (Responsible Party):
Galera Therapeutics, Inc.

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: GC4702 dry powder Drug: GC4702 lipid suspension Other: GC4419 IV Other: Placebo Dry Powder Other: Placebo lipid suspension Other: Fed Condition Other: Fasting Condition Drug: GC4702 lipid suspension - Part 2 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official 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
Actual Study Start Date : July 26, 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Arm Intervention/treatment
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.
Drug: 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

Drug: 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: 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: 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: 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.

Experimental: Part 2: Food Effect Study
Following Part 1 dose find, single dose level of GC4702 administered under fasting for and fed condition.
Other: 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: 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.

Drug: 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




Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events and Laboratory Abnormalities [ Time Frame: From randomization through 4 days post last dosing in Active Phase of each cohort. ]
    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, 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.

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.

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): NCT03096756


Locations
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Australia, Victoria
Nucleus Network Limited
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Galera Therapeutics, Inc.
INC Research Australia Pty Ltd
Nucleous Network
Investigators
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Study Chair: Jon T Holmlund, MD Galera Therapeutics, Inc.
Principal Investigator: Jason Lickliter, MBBS, PhD, FRACP Nucleus Network
Study Director: David Fuller, MD Syneos Health
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Responsible Party: Galera Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03096756    
Other Study ID Numbers: GTO-001
First Posted: March 30, 2017    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Galera Therapeutics, Inc.:
Oral Formulation
Food Effect
Superoxide Dismutase
Single Ascending Dose
GC4702
Bioavailability
Pharmacokinetics
Active Comparator