Skip to main content
Clinical Trials/NCT02897869
NCT02897869CompletedPhase 1

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

Polyphor Ltd.0 sites14 target enrollmentStarted: April 2016Last updated:
Conditions
Interventions
Drugs

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

Experimental

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

Experimental

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

Experimental

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

Experimental

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

Experimental

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

Experimental

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)

Investigators

Sponsor
Polyphor Ltd.
Sponsor Class
Industry
Responsible Party
Sponsor

Similar Trials