A Study of the Safety, Tolerability and Pharmacokinetics of Orally-administered GC4702 in Healthy Volunteers
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|ClinicalTrials.gov Identifier: NCT03096756|
Recruitment Status : Completed
First Posted : March 30, 2017
Last Update Posted : April 4, 2017
|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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|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|
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
- 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.
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
|Nucleus Network Limited|
|Melbourne, Victoria, Australia, 3004|
|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|