DDI Study to Investigate Interaction Between Amikacin and POL7080

Polyphor

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: POL7080; Drug: Amikacin; Drug: POL7080 + Amikacin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02897869

POL7080-009

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Treatment sequence 1

Experimental group

Description:

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:

Drug: Amikacin

Drug: POL7080

Drug: POL7080 + Amikacin

Treatment sequence 2

Experimental group

Description:

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:

Drug: Amikacin

Drug: POL7080

Drug: POL7080 + Amikacin