NCT03792971

Study to Evaluate the Effects of 90 mg Intravenous Infusions of GC4419 on the Single Dose Pharmacokinetics of Dextromethorphan in Healthy Adult Subjects

Phase 1, Open-label, One-arm, Fixed-sequence Study to Evaluate the Effects of 90 mg Intravenous Infusions of GC4419 on the Single Dose Pharmacokinetics of Dextromethorphan in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Galera Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This will be a single center, phase 1, open-label, fixed-sequence study under fasting conditions to evaluate the effect of 90 mg intravenous (IV) infusions of GC4419 on the single-dose pharmacokinetic (PK) of dextromethorphan (DM) capsules liquid filled.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Dextromethorphan HBr	A single 60 mg dose of DM capsules liquid-filled on Day 1 and Day 3
DRUG	GC4419	Daily 90 mg IV infusions over 60 minutes on Day 3 and Day 4

Timeline

• Start date: 2019-02-10
• Primary completion: 2019-02-15
• Completion: 2019-02-15
• First posted: 2019-01-04
• Last updated: 2019-06-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study