Pharmacokinetics and Safety of POL7080 in Patients With Renal Impairment

NCT02110459 | Completed Phase 1

• 1 other identifier: POL7080-005
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Renal Impairment

Keywords

POL7080; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Adverse events

  Daily assessment up to 7 days from informed consent

• Laboratory abnormalities

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

Study Arms (6)

Mild renal impairment

EXPERIMENTAL

3h IV POL7080 infusion

Drug: POL7080

Moderate renal impairment

EXPERIMENTAL

3h IV POL7080 infusion

Drug: POL7080

Severe renal impairment

EXPERIMENTAL

3h IV POL7080 infusion

Drug: POL7080

End stage renal disease arm 1

EXPERIMENTAL

3h IV POL7080 infusion

Drug: POL7080

End stage renal disease arm 2

EXPERIMENTAL

3h IV POL7080 infusion

Drug: POL7080

Normal Renal function

EXPERIMENTAL

3h IV POL7080 infusion

Drug: POL7080

Interventions

POL7080 DRUG

Intravenous infusion

End stage renal disease arm 1; End stage renal disease arm 2; Mild renal impairment; Moderate renal impairment; Normal Renal function; Severe renal impairment

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• mL/min (mild renal impairment)
• \<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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Polyphor Ltd.: lead

Study Sites (1)

CRS Clinical Research Services Kiel GmbH

Kiel, 24105, Germany

Location

Related Publications (1)

• 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.

  PMID: 30012756 DERIVED

MeSH Terms

Conditions

Renal Insufficiency

Interventions

murepavadin

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Atef Halabi, MD

  CRS Clinical Research Services Kiel GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2014
• First Posted: April 10, 2014
• Study Start: April 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: June 17, 2016

Record last verified: 2016-06

Locations

DE (1)