Pharmacokinetics and Safety of POL7080 in Patients With Renal Impairment

Phase 1

Completed

• Conditions: Renal Impairment
• Interventions: Drug: POL7080

• Registration Number: NCT02110459
• Lead Sponsor: Polyphor Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2014-04-08
• Study First Submitted QC: 2014-04-08
• Study First Posted: 2014-04-10
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-16
• Last Update Posted: 2016-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Moderate renal impairment	POL7080	3h IV POL7080 infusion
Severe renal impairment	POL7080	3h IV POL7080 infusion
End stage renal disease arm 1	POL7080	3h IV POL7080 infusion
End stage renal disease arm 2	POL7080	3h IV POL7080 infusion
Normal Renal function	POL7080	3h IV POL7080 infusion
Mild renal impairment	POL7080	3h IV POL7080 infusion

Primary Outcome Measures

Name	Time	Method
To measure the plasma concentrations of POL7080	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 Measures

Name	Time	Method
Laboratory abnormalities	Screening, Day -1, Day 2, Day 3, and Day 7	The number and severity of blood chemistry and hematology findings will be summarized descriptively and compared to baseline.
Adverse events	Daily assessment up to 7 days from informed consent	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.

Trial Locations

Locations (1)

CRS Clinical Research Services Kiel GmbH; 🇩🇪 Kiel, Germany