DDI Study to Investigate Interaction Between Amikacin and POL7080

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2016-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment sequence 1

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.

Group Type EXPERIMENTAL

POL7080

Intervention Type DRUG

7 doses of POL7080 alone over 2.5 days

Amikacin

Intervention Type DRUG

3 doses of Amikacin alone over 2.5 days

POL7080 + Amikacin

Intervention Type DRUG

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

Treatment sequence 2

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.

Group Type EXPERIMENTAL

POL7080

Intervention Type DRUG

7 doses of POL7080 alone over 2.5 days

Amikacin

Intervention Type DRUG

3 doses of Amikacin alone over 2.5 days

POL7080 + Amikacin

Intervention Type DRUG

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

Interventions

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POL7080

7 doses of POL7080 alone over 2.5 days

Intervention Type DRUG

Amikacin

3 doses of Amikacin alone over 2.5 days

Intervention Type DRUG

POL7080 + Amikacin

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes