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DDI Study to Investigate Interaction Between Amikacin and POL7080

NCT02897869 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2017-02-01

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

POL7080

7 doses of POL7080 alone over 2.5 days

DRUG

Amikacin

3 doses of Amikacin alone over 2.5 days

DRUG

POL7080 + Amikacin

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

Sponsors & Collaborators

  • Polyphor Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2016-08-31
Completion
2016-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02897869 on ClinicalTrials.gov