Pharmacokinetics and Safety of POL7080 in Patients With Renal Impairment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-07-31

Brief Summary

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

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Detailed Description

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Conditions

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Renal Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Mild renal impairment

3h IV POL7080 infusion

Group Type EXPERIMENTAL

POL7080

Intervention Type DRUG

Intravenous infusion

Moderate renal impairment

3h IV POL7080 infusion

Group Type EXPERIMENTAL

POL7080

Intervention Type DRUG

Intravenous infusion

Severe renal impairment

3h IV POL7080 infusion

Group Type EXPERIMENTAL

POL7080

Intervention Type DRUG

Intravenous infusion

End stage renal disease arm 1

3h IV POL7080 infusion

Group Type EXPERIMENTAL

POL7080

Intervention Type DRUG

Intravenous infusion

End stage renal disease arm 2

3h IV POL7080 infusion

Group Type EXPERIMENTAL

POL7080

Intervention Type DRUG

Intravenous infusion

Normal Renal function

3h IV POL7080 infusion

Group Type EXPERIMENTAL

POL7080

Intervention Type DRUG

Intravenous infusion

Interventions

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POL7080

Intravenous infusion

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes