A Single-center, Open-label, Two Sequence, Crossover Study to Investigate the Interaction Between Amikacin and POL7080 in Healthy Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 14
- Primary Endpoint
- Multiple dose pharmacokinetics of POL7080 and Amikacin (as appropriate):Area under the plasma concentration versus time curve (AUC)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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.
Intervention: POL7080 (Drug)
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.
Intervention: Amikacin (Drug)
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.
Intervention: POL7080 + Amikacin (Drug)
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.
Intervention: POL7080 (Drug)
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.
Intervention: Amikacin (Drug)
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.
Intervention: POL7080 + Amikacin (Drug)
Outcomes
Primary Outcomes
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
Multiple dose pharmacokinetics of POL7080 and Amikacin (as appropriate): Peak Plasma Concentration (Cmax)
Time Frame: Up to 4 days for each period
Secondary Outcomes
- Incidence of adverse Events(up to 19 days)