DDI Study to Investigate Interaction Between Amikacin and POL7080

A Single-center, Open-label, Two Sequence, Crossover Study to Investigate the Interaction Between Amikacin and POL7080 in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02897869

Enrollment

Registered

2016-09-13

Start date

2016-04-30

Completion date

2016-12-31

Last updated

2017-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGPOL7080

7 doses of POL7080 alone over 2.5 days

DRUGAmikacin

3 doses of Amikacin alone over 2.5 days

DRUGPOL7080 + Amikacin

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Incidence of adverse Events	up to 19 days

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026