A Study of the Safety, Tolerability and Pharmacokinetics of Orally-administered GC4702 in Healthy Volunteers

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.

Conditions

• Healthy Volunteer

Interventions

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.

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

Sponsors & Collaborators

• INC Research Australia Pty Ltd

  collaborator UNKNOWN

• Nucleous Network

  collaborator UNKNOWN

• Galera Therapeutics, Inc.

  lead INDUSTRY

Principal Investigators

• Jon T Holmlund, MD · Galera Therapeutics, Inc.

• Jason Lickliter, MBBS, PhD, FRACP · Nucleus Network

• David Fuller, MD · Syneos Health

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-07-26

Primary Completion

2016-12-31

Completion

2016-12-31

Countries

• Australia

Study Locations