DDI Study to Investigate Interaction Between Amikacin and POL7080
- Registration Number
- NCT02897869
- Lead Sponsor
- Polyphor Ltd.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment sequence 1 POL7080 + Amikacin 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. Treatment sequence 1 POL7080 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. Treatment sequence 2 POL7080 + Amikacin 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. Treatment sequence 2 POL7080 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. Treatment sequence 1 Amikacin 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. Treatment sequence 2 Amikacin 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.
- Primary Outcome Measures
Name Time Method 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 Multiple dose pharmacokinetics of POL7080 and Amikacin (as appropriate): Peak Plasma Concentration (Cmax) Up to 4 days for each period
- Secondary Outcome Measures
Name Time Method Incidence of adverse Events up to 19 days