NCT03164109

A Phase 1, Randomized, Placebo-and Positive-Controlled Crossover Study to Determine the Effect of Single-Dose GC4419 on QTc Interval in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Galera Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a partially double-blind study in healthy adult subjects, which will be conducted as a placebo- and active-controlled, single-dose, crossover study. Twenty-eight subjects will be enrolled to ensure 24 subjects on all study periods. All subjects will receive all 3 study treatments (GC4419, placebo and moxifloxacin) in randomized sequence. Cardiodynamic assessment using continuous ECG recordings (Holters) will be performed for approximately 26 hours on the day of dosing (Day 1) in each study period. ECGs will be extracted serially pre- and post-dose and predefined timepoints at which subjects will be supinely resting. Subjects will be supinely resting for at least 10 minutes prior to and 5 minutes after each nominal timepoint for ECG extraction. Blood draws for PK will be performed in all periods at the same timepoints and always after ECG extraction. Subjects will be domiciled in the clinic from noon/afternoon of the day before dosing (Day -1) until completion of safety procedures on Day 2 in each study period. All subjects (including subjects who terminate the study early) will return to the clinical research unit (CRU) 14 (± 1) days after the last administration of study treatment for follow-up procedures and to determine if any Adverse Event (AE) has occurred since the last study visit.

Conditions

• Healthy Volunteers
• Healthy

Interventions

Type	Name	Description
DRUG	GC4419 IV	50mg infused IV over 15 minutes
DRUG	Placebo	Infused IV over 15 minutes
DRUG	Oral moxifloxacin	400 mg tablet orally with 250 mL room temperature water

Timeline

• Start date: 2017-08-18
• Primary completion: 2017-10-13
• Completion: 2017-10-13
• First posted: 2017-05-23
• Last updated: 2017-11-17

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study