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Trial · Interventional

CompletedPhase 1Registry data

Pharmacokinetics and Safety of POL7080 in Patients With Renal Impairment

NCTNCT02110459 (opens ClinicalTrials.gov in a new tab)Other idPOL7080-005
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
48 participants (actual)
Sponsor
Polyphor Ltd. · Industry
Design
Not randomized · Open label (no masking)
Countries
1 country

Germany

Start
Apr 2013
Primary completion
Jul 2015
Completion
Jul 2015
First posted
10 Apr 2014 (estimated)
Last update posted
17 Jun 2016 (estimated)
Conditions
Renal Impairment

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2013201420152016
  1. Ph 1

    Pharmacokinetics and Safety of POL7080 in Patients With Renal Impairment

    NCT02110459

    Apr 2013 to Jul 2015

Registry summary

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

To investigate the pharmacokinetics (PK) of POL7080 in subjects with renal function impairment after single intravenous (IV) infusion of POL7080

Interventions

  • POL7080Drug

Arms6

  • Experimental

    Mild renal impairment

    3h IV POL7080 infusion

  • Experimental

    Moderate renal impairment

    3h IV POL7080 infusion

  • Experimental

    Severe renal impairment

    3h IV POL7080 infusion

  • Experimental

    End stage renal disease arm 1

    3h IV POL7080 infusion

  • Experimental

    End stage renal disease arm 2

    3h IV POL7080 infusion

  • Experimental

    Normal Renal function

    3h IV POL7080 infusion

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. To measure the plasma concentrations of POL7080

    Time frame · at baseline, 0.5, 1,1.5 and 3 hours after start of infusion, at 1, 2, 3, 4, 5, 6, 8, 12, 24, 48 and 72 hours after end of infusion

Secondary outcomes(2)

  1. Adverse events

    Time frame · Daily assessment up to 7 days from informed consent

    Registry description

    Number of adverse events reported by the patients or observed by the investigator will be recorded. Onset, end date, severity, causal relationship, outcome and measures taken will be summarized. Discontinuations and serious adverse events will be listed and narrative summaries will be provided.

  2. Laboratory abnormalities

    Time frame · Screening, Day -1, Day 2, Day 3, and Day 7

    Registry description

    The number and severity of blood chemistry and hematology findings will be summarized descriptively and compared to baseline.

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

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 2018

5 results

Pharmacokinetics, Tolerability, and Safety of Murepavadin, a Novel Antipseudomonal Antibiotic, in Subjects with Mild, Moderate, or Severe Renal Function Impairment.

Dale et al. 2018Antimicrobial agents and chemotherapycited by 29

PMID 30012756PMC6125514DOI 10.1128/aac.00490-18PUB-30012756

Rights unknown5 results
Source linkSee results (5)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 79 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Subjects who signed informed consent. 2. Male subjects ≥18 and ≤79 years of age; female subjects ≥18 and ≤79 years of age of non-childbearing potential 3. Weight within a BMI range of 19.0-35.0 kg/m2. 4. CLCr according to Cockcroft Gault equation of: * 50-80 mL/min (mild renal impairment) * 30- \<50 mL/min (moderate renal impairment) * \<30 mL/min (severe renal impairment) * subjects receiving dialysis for ≥3 months before dosing (ESRD) * \>80 mL/min (normal renal function) Exclusion Criteria: 1. Unwilling or unable to give informed consent. 2. As a result of the medical screening process, the study physician considers the subject unfit for the study. 3. Demonstrating excess in xanthine consumption (more than 5 cups of coffee or equivalent per day). 4. Subjects who smoke more than 10 cigarettes a day. 5. Subjects who consume more than 28 units (males) or more than 21 units (females) of alcohol per week. 6. Any history of hypersensitivity to the IMP. 7. For subjects with renal impairment: No clinically significant change in disease status within at least 1 month prior to study entry, as determined by the investigator. 8. The subject had donated a unit of blood (450 mL) within the 3 months before dosing, or intends to donate in the month after the last scheduled visit. 9. Participation in another clinical study with an investigational drug or device within the last month. 10. Subjects with clinically significant telemetric ECG abnormalities on Day -1 11. Significant allergies requiring intranasal or systemic corticosteroids during any time of the year or history of any anaphylactic reaction. 12. Positive test for human immunodeficiency virus (HIV) antibodies. 13. Acute Hepatitis B or C infection. 14. The subject has tested positive for drugs of abuse at screening. 15. Subjects who have received any prescribed systemic or topical medication within 4 weeks prior to dosing (excluded are those drugs the renally impaired subject is currently taking for treatment of the renal or concomitant disease). 16. Immunocompromised patients (patients after solid organ or bone marrow transplant; patients receiving immunosuppressive treatment). 17. Subjects with known or suspected Pseudomonas infection or colonization (e.g. patients with cystic fibrosis). 18. Subjects with significant liver function abnormalities 19. Subjects with acute myocardial infection or unstable angina pectoris

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