Pharmacokinetics and Safety of POL7080 in Patients With Renal Impairment

Polyphor

Status and phase: Completed; Phase 1

Conditions: Renal Impairment

Treatments: Drug: POL7080

Study type: Interventional

Funder types: Industry

Identifiers

NCT02110459

POL7080-005

Details and patient eligibility

About

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

Enrollment: 48 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 6 patient groups

Mild renal impairment

Experimental group

Description:

3h IV POL7080 infusion

Treatment:

Drug: POL7080

Moderate renal impairment

Experimental group

Description:

3h IV POL7080 infusion

Treatment:

Drug: POL7080

Severe renal impairment

Experimental group

Description:

3h IV POL7080 infusion

Treatment:

Drug: POL7080

End stage renal disease arm 1

Experimental group

Description:

3h IV POL7080 infusion

Treatment:

Drug: POL7080

End stage renal disease arm 2

Experimental group

Description:

3h IV POL7080 infusion

Treatment:

Drug: POL7080

Normal Renal function

Experimental group

Description:

3h IV POL7080 infusion

Treatment:

Drug: POL7080