Pharmacokinetics and Safety of POL7080 in Patients With Renal Impairment

Renal Impairment Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02110459
• Other study ID #: POL7080-005
• Status: Completed
• Phase: Phase 1
• First received: April 8, 2014
• Last updated: June 16, 2016
• Start date: April 2013
• Est. completion date: July 2015

Study information

• Verified date: June 2016
• Source: Polyphor Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Renal Impairment
• Renal Insufficiency

Intervention

Drug:
• POL7080
Intravenous infusion

Locations

Country	Name	City	State
Germany	CRS Clinical Research Services Kiel GmbH	Kiel

Sponsors (1)

Lead Sponsor	Collaborator
Polyphor Ltd.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	Daily assessment up to 7 days from informed consent	Yes
Secondary	Laboratory abnormalities	The number and severity of blood chemistry and hematology findings will be summarized descriptively and compared to baseline.	Screening, Day -1, Day 2, Day 3, and Day 7	Yes