NCT02897869

DDI Study to Investigate Interaction Between Amikacin and POL7080

A Single-center, Open-label, Two Sequence, Crossover Study to Investigate the Interaction Between Amikacin and POL7080 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Polyphor Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Single-center, open-label, 2-sequence, 3-period crossover drug-drug interaction study. Repeated doses of POL7080 and repeated doses of amikacin will be administered alone or combined. In total, 14 subjects will be enrolled to obtain at least 10 evaluable subjects. The study consists of an eligibility screening period, up to 3 treatments periods and a follow-up visit.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	POL7080	7 doses of POL7080 alone over 2.5 days
DRUG	Amikacin	3 doses of Amikacin alone over 2.5 days
DRUG	POL7080 + Amikacin	7 doses of POL7080 and 3 doses of Amikacin over 2.5 days

Timeline

• Start date: 2016-04-01
• Primary completion: 2016-08-01
• Completion: 2016-12-01
• First posted: 2016-09-13
• Last updated: 2017-02-01

Locations

1 site across 1 country: Germany