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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

NCT03099824 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2021-03-02

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Galera Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Jon T Holmlund, MD · Chief Medical Officer

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-16
Primary Completion
2020-01-27
Completion
2020-01-27
FDA Drug
Yes

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03099824 on ClinicalTrials.gov