Overview

This trial is active, not recruiting.

Condition healthy
Treatments pol7080, amikacin, pol7080 + amikacin
Phase phase 1
Sponsor Polyphor Ltd.
Start date April 2016
End date August 2016
Trial size 14 participants
Trial identifier NCT02897869, POL7080-009

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
pol7080
7 doses of POL7080 alone over 2.5 days
amikacin
3 doses of Amikacin alone over 2.5 days
pol7080 + amikacin
7 doses of POL7080 and 3 doses of Amikacin over 2.5 days
(Experimental)
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.
pol7080
7 doses of POL7080 alone over 2.5 days
amikacin
3 doses of Amikacin alone over 2.5 days
pol7080 + amikacin
7 doses of POL7080 and 3 doses of Amikacin over 2.5 days

Primary Outcomes

Measure
Multiple dose pharmacokinetics of POL7080 and Amikacin (as appropriate): Peak Plasma Concentration (Cmax)
time frame: 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)
time frame: Up to 4 days for each period

Secondary Outcomes

Measure
Incidence of adverse Events
time frame: up to 19 days

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

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

Additional Information

Official title A Single-center, Open-label, Two Sequence, Crossover Study to Investigate the Interaction Between Amikacin and POL7080 in Healthy Subjects
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Polyphor Ltd..