DDI Study to Investigate Interaction Between Amikacin and POL7080

NCTNCT02897869Other idPOL7080-009

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 1
Enrollment: 14 participants (actual)
Sponsor: Polyphor Ltd. · Industry
Design: Randomized · Open label (no masking)
Countries: 1 country
Germany
Start: Apr 2016
Primary completion: Aug 2016
Completion: Dec 2016
First posted: 13 Sept 2016 (estimated)
Last update posted: 1 Feb 2017 (estimated)
Conditions: Healthy

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20162017

Ph 1
DDI Study to Investigate Interaction Between Amikacin and POL7080
NCT02897869
Apr 2016 to Dec 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

POL7080Drug
AmikacinDrug
POL7080 + AmikacinDrug

Arms2

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.
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.

Primary outcomes2

Outcomes the sponsor listed as primary.

Multiple dose pharmacokinetics of POL7080 and Amikacin (as appropriate): Peak Plasma Concentration (Cmax)
Time frame · 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)
Time frame · Up to 4 days for each period

Secondary outcomes(1)

Incidence of adverse Events
Time frame · up to 19 days

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 55 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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

PepBank is a research reference. Talk to a doctor before you use any peptide.