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Pharmacokinetics and Safety of POL7080 in Patients With Renal Impairment

Primary Purpose

Renal Impairment

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

POL7080

About this trial

This is an interventional basic science trial for Renal Impairment focused on measuring POL7080, Pharmacokinetics

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Subjects who signed informed consent.
Male subjects ≥18 and ≤79 years of age; female subjects ≥18 and ≤79 years of age of non-childbearing potential
Weight within a BMI range of 19.0-35.0 kg/m2.
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:

Unwilling or unable to give informed consent.
As a result of the medical screening process, the study physician considers the subject unfit for the study.
Demonstrating excess in xanthine consumption (more than 5 cups of coffee or equivalent per day).
Subjects who smoke more than 10 cigarettes a day.
Subjects who consume more than 28 units (males) or more than 21 units (females) of alcohol per week.
Any history of hypersensitivity to the IMP.
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.
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.
Participation in another clinical study with an investigational drug or device within the last month.
Subjects with clinically significant telemetric ECG abnormalities on Day -1
Significant allergies requiring intranasal or systemic corticosteroids during any time of the year or history of any anaphylactic reaction.
Positive test for human immunodeficiency virus (HIV) antibodies.
Acute Hepatitis B or C infection.
The subject has tested positive for drugs of abuse at screening.
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).
Immunocompromised patients (patients after solid organ or bone marrow transplant; patients receiving immunosuppressive treatment).
Subjects with known or suspected Pseudomonas infection or colonization (e.g. patients with cystic fibrosis).
Subjects with significant liver function abnormalities
Subjects with acute myocardial infection or unstable angina pectoris

Sites / Locations

CRS Clinical Research Services Kiel GmbH

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

Mild renal impairment

Moderate renal impairment

Severe renal impairment

End stage renal disease arm 1

End stage renal disease arm 2

Normal Renal function

Arm Description

3h IV POL7080 infusion

Outcomes

Primary Outcome Measures

To measure the plasma concentrations of POL7080

Secondary Outcome Measures

Adverse events

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.

Laboratory abnormalities

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

Full Information

NCT ID

NCT02110459

First Posted

April 8, 2014

Last Updated

June 16, 2016

Sponsor

Polyphor Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02110459

Brief Title

Pharmacokinetics and Safety of POL7080 in Patients With Renal Impairment

Official Title

An Open-label, Non-randomized, Monocenter, Single-dose, Phase I Study to Evaluate Pharmacokinetics and Safety of POL7080 Administered as Single Intravenous Infusion to Subjects With Renal Impairment

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Completed

Study Start Date

April 2013 (undefined)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Polyphor Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Impairment

Keywords

POL7080, Pharmacokinetics

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mild renal impairment

Arm Type

Experimental

Arm Description

3h IV POL7080 infusion

Arm Title

Moderate renal impairment

Arm Type

Experimental

Arm Description

3h IV POL7080 infusion

Arm Title

Severe renal impairment

Arm Type

Experimental

Arm Description

3h IV POL7080 infusion

Arm Title

End stage renal disease arm 1

Arm Type

Experimental

Arm Description

3h IV POL7080 infusion

Arm Title

End stage renal disease arm 2

Arm Type

Experimental

Arm Description

3h IV POL7080 infusion

Arm Title

Normal Renal function

Arm Type

Experimental

Arm Description

3h IV POL7080 infusion

Intervention Type

Drug

Intervention Name(s)

POL7080

Intervention Description

Intravenous infusion

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

Adverse events

Description

Time Frame

Daily assessment up to 7 days from informed consent

Title

Laboratory abnormalities

Description

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

Time Frame

Screening, Day -1, Day 2, Day 3, and Day 7

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects who signed informed consent. Male subjects ≥18 and ≤79 years of age; female subjects ≥18 and ≤79 years of age of non-childbearing potential Weight within a BMI range of 19.0-35.0 kg/m2. 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: Unwilling or unable to give informed consent. As a result of the medical screening process, the study physician considers the subject unfit for the study. Demonstrating excess in xanthine consumption (more than 5 cups of coffee or equivalent per day). Subjects who smoke more than 10 cigarettes a day. Subjects who consume more than 28 units (males) or more than 21 units (females) of alcohol per week. Any history of hypersensitivity to the IMP. 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. 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. Participation in another clinical study with an investigational drug or device within the last month. Subjects with clinically significant telemetric ECG abnormalities on Day -1 Significant allergies requiring intranasal or systemic corticosteroids during any time of the year or history of any anaphylactic reaction. Positive test for human immunodeficiency virus (HIV) antibodies. Acute Hepatitis B or C infection. The subject has tested positive for drugs of abuse at screening. 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). Immunocompromised patients (patients after solid organ or bone marrow transplant; patients receiving immunosuppressive treatment). Subjects with known or suspected Pseudomonas infection or colonization (e.g. patients with cystic fibrosis). Subjects with significant liver function abnormalities Subjects with acute myocardial infection or unstable angina pectoris

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Atef Halabi, MD

Organizational Affiliation

CRS Clinical Research Services Kiel GmbH

Official's Role

Principal Investigator

Facility Information:

Facility Name

CRS Clinical Research Services Kiel GmbH

City

Kiel

ZIP/Postal Code

24105

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

30012756

Citation

Dale GE, Halabi A, Petersen-Sylla M, Wach A, Zwingelstein C. Pharmacokinetics, Tolerability, and Safety of Murepavadin, a Novel Antipseudomonal Antibiotic, in Subjects with Mild, Moderate, or Severe Renal Function Impairment. Antimicrob Agents Chemother. 2018 Aug 27;62(9):e00490-18. doi: 10.1128/AAC.00490-18. Print 2018 Sep.

Results Reference

derived

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Pharmacokinetics and Safety of POL7080 in Patients With Renal Impairment

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