DDI Study to Investigate Interaction Between Amikacin and POL7080

Sponsor

Polyphor Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT02897869

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: POL7080 Drug: Amikacin Drug: POL7080 + Amikacin	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2016

Actual Primary Completion Date :

Aug 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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
Experimental: 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.	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

Arm

Intervention/Treatment

Experimental: 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.

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

Experimental: 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.

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Incidence of adverse Events [up to 19 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Mönchengladbach		Germany

Sponsors and Collaborators

Polyphor Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Polyphor Ltd.

ClinicalTrials.gov Identifier:

NCT02897869

Other Study ID Numbers:

POL7080-009

First Posted:

Sep 13, 2016

Last Update Posted:

Feb 1, 2017

Last Verified:

Jan 1, 2017

Additional relevant MeSH terms:

Amikacin

Murepavadin

Study Results

No Results Posted as of Feb 1, 2017