DDI Study to Investigate Interaction Between Amikacin and POL7080

Polyphor Ltd.14 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

POL7080DRUG

7 doses of POL7080 alone over 2.5 days

AmikacinDRUG

3 doses of Amikacin alone over 2.5 days

POL7080 + AmikacinDRUG

7 doses of POL7080 and 3 doses of Amikacin over 2.5 days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Mönchengladbach, Germany

Outcomes

Primary Outcomes

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

Incidence of adverse Events

Time frame: up to 19 days

Data from ClinicalTrials.gov

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