DDI Study to Investigate Interaction Between Amikacin and POL7080

NCT02897869 | Completed Phase 1

• 1 other identifier: POL7080-009
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Incidence of adverse Events

  up to 19 days

Study Arms (2)

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.

Drug: POL7080; Drug: Amikacin; Drug: POL7080 + Amikacin

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.

Drug: POL7080; Drug: Amikacin; Drug: POL7080 + Amikacin

Interventions

POL7080 DRUG

7 doses of POL7080 alone over 2.5 days

Treatment sequence 1; Treatment sequence 2

Amikacin DRUG

3 doses of Amikacin alone over 2.5 days

Treatment sequence 1; Treatment sequence 2

POL7080 + Amikacin DRUG

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

Treatment sequence 1; Treatment sequence 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Polyphor Ltd.: lead

Study Sites (1)

Unknown Facility

Mönchengladbach, Germany

Location

MeSH Terms

Interventions

murepavadin; Amikacin

Intervention Hierarchy (Ancestors)

Kanamycin; Aminoglycosides; Glycosides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2016
• First Posted: September 13, 2016
• Study Start: April 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 1, 2017

Record last verified: 2017-01

Locations

DE (1)