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Completed

NCT Number: NCT02897869

DDI Study to Investigate Interaction Between Amikacin and POL7080

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Mönchengladbach, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

POL7080

Drug

7 doses of POL7080 alone over 2.5 days

Amikacin

Drug

3 doses of Amikacin alone over 2.5 days

POL7080 + Amikacin

Drug

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

Primary outcomes

  1. Multiple dose pharmacokinetics of POL7080 and Amikacin (as appropriate): Peak Plasma Concentration (Cmax)

    Time frame: Up to 4 days for each period

  2. 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

  1. Incidence of adverse Events

    Time frame: up to 19 days

Sponsors and collaborators

Lead sponsor

Polyphor Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Sep 13, 2016
Registry last updated
Feb 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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