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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: POL7080; Drug: Amikacin; Drug: POL7080 + Amikacin

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Mönchengladbach, Germany

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy male and female (of non-childbearing potential) subjects between 18 to 55 years of age (inclusive)
• BMI between 18.0-30.0 kg/m2
• Creatinine clearance estimated by Cockroft Gault formula > 80 mL/min and < 160 ml/min (for males), or < 150ml/min (females)
• Non smokers
• Normal audiogram.

Exclusion Criteria:

• History or suspicion of alcohol and/or drug abuse in the last 5 years
• Within 2 months prior to screening: exposure to aminoglycoside antibiotic, chemotherapy, or current use of loop diuretics
• Regular consumption of large amounts of xanthine
• Any medication that inhibits active tubular secretion within 4 weeks prior to first dosing
• Infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV)
• Any signs of renal impairment
• Clinically significant abnormalities (e.g. cardiovascular, laboratory values)
• Clinically significant abnormal ECG

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment sequence 1; Participants will be randomized to one of two treatment sequences. Sequence 1 is: Period 1, POL7080; Period 2, Amikacin; Period 3,POL7080+Amikacin. Each period is separated by a wash-out period of at least 12 days between last dose and start of next treatment.	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
Experimental: Treatment sequence 2; Participants will be randomized to one of two treatment sequences. Sequence 1 is: Period 1, Amikacin; Period 2, POL7080; Period 3,POL7080+Amikacin. Each period is separated by a wash-out period of at least 12 days between last dose and start of next treatment.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Multiple dose pharmacokinetics of POL7080 and Amikacin (as appropriate): Peak Plasma Concentration (Cmax)	Up to 4 days for each period
Multiple dose pharmacokinetics of POL7080 and Amikacin (as appropriate):Area under the plasma concentration versus time curve (AUC)	Up to 4 days for each period

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse Events	up to 19 days

Collaborators and Investigators

• Sponsor: Polyphor Ltd.

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: September 2, 2016
• First Submitted That Met QC Criteria: September 7, 2016
• First Posted (Estimate): September 13, 2016

Study Record Updates

• Last Update Posted (Estimate): February 1, 2017
• Last Update Submitted That Met QC Criteria: January 31, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents; Amikacin; Murepavadin
• Other Study ID Numbers: POL7080-009