NCT03099824 - 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 | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

October 16, 2018

Primary Completion Date

January 27, 2020

Study Completion Date

January 27, 2020

Conditions

Healthy Volunteers

Interventions

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.

DRUG

GC4711 Oral Capsule G-101

164 mg (2 capsules)

DRUG

GC4711 Oral Capsule G-101

246 mg (3 capsules)

DRUG

GC4711 Oral Capsule G-111

175 mg (1 capsule)

DRUG

GC4711 Oral Capsule G-112

145 mg (1 capsule)

DRUG

GC4711 Oral Capsule G-119

233 mg (1 capsule)

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.

Trial Locations (1)

Nucleus Network, Melbourne