Pharmacokinetics, Tolerability, and Safety of Murepavadin, a Novel Antipseudomonal Antibiotic, in Subjects with Mild, Moderate, or Severe Renal Function Impairment.

Dale GE, Halabi A, Petersen-Sylla M, Wach A, Zwingelstein C

Antimicrobial agents and chemotherapy27 Aug 2018Cited by 29 (Europe PMC)

PMID30012756PMCIDPMC6125514DOI10.1128/aac.00490-18PepBankPUB-30012756

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

01HumanNon-randomized trialPharmacokinetics
In subjects with renal impairment, murepavadin plasma AUC increased about 2.0- to 2.5-fold versus normal renal function.
In plain wordsIn people with renal impairment, murepavadin plasma AUC was about 2.0- to 2.5-fold higher than with normal renal function.
Peptide
Murepavadin
Outcome
IncreasePlasma AUC
Study
n = 32
Comparator
Normal renal function
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
2.2 mg/kg · intravenous infusion · single dose over 3 hAs given in this study (human).
Measurements
AUC0-inf fold change
2 to 2.5 fold
renal function impairment vs normal renal function
Source sentences
Summary
Exposure to murepavadin in plasma increased in subjects with renal function impairment, with the area under the plasma concentration-time curve from zero to infinity (AUC_0-∞) increasing about 2.0- to 2.5-fold for subjects with renal function impairment compared to subjects with normal renal function, whereas
2 context sentences(design, population, supporting numbers)
Summary · context
This open-label, nonrandomized, single-dose, phase 1 study evaluated the pharmacokinetics and safety of murepavadin, a novel peptide antibiotic for the treatment of serious Pseudomonas aeruginosa infections.
Summary · context
All subjects received a single 2.2-mg/kg of body weight intravenous infusion of murepavadin administered over 3 h.
Report a problemFND-3001275601
02HumanNon-randomized trialPharmacokinetics
In subjects with renal impairment, murepavadin maximum plasma concentration increased about 1.5-fold versus normal renal function.
In plain wordsIn people with renal impairment, murepavadin peak blood concentration was about 1.5-fold higher than with normal renal function.
Peptide
Murepavadin
Outcome
IncreaseMaximum plasma concentration
Study
n = 32
Comparator
Normal renal function
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
2.2 mg/kg · intravenous infusion · single dose over 3 hAs given in this study (human).
Measurements
Cmax fold change
≈ 1.5 fold
renal function impairment vs normal renal function
Source sentences
Summary
whereas the increases in maximum observed plasma concentration (C_max) were about 1.5-fold for subjects with renal function impairment compared to subjects with normal renal function.
2 context sentences(design, population, supporting numbers)
Summary · context
This open-label, nonrandomized, single-dose, phase 1 study evaluated the pharmacokinetics and safety of murepavadin, a novel peptide antibiotic for the treatment of serious Pseudomonas aeruginosa infections.
Summary · context
All subjects received a single 2.2-mg/kg of body weight intravenous infusion of murepavadin administered over 3 h.
Report a problemFND-3001275602
03HumanNon-randomized trialPharmacokinetics
In subjects with renal impairment, mean murepavadin clearance ranged from 2.4 to 3.8 liters/h versus 7.0 liters/h with normal renal function.
In plain wordsIn people with renal impairment, murepavadin clearance was lower than in people with normal renal function.
Peptide
Murepavadin
Outcome
DecreaseTotal clearance
Study
n = 32
Comparator
Normal renal function
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
2.2 mg/kg · intravenous infusion · single dose over 3 hAs given in this study (human).
Measurements
Clearance
2.4 to 3.8 liters/h
Renal impairment
Clearance
7 liters/h
Normal renal function
Source sentences
Summary
The total clearance (CL) of murepavadin was lower in all groups of subjects with renal function impairment, with group means ranging from 2.4 liters/h to 3.8 liters/h, compared to 7.0 liters/h in subjects with normal renal function.
2 context sentences(design, population, supporting numbers)
Summary · context
This open-label, nonrandomized, single-dose, phase 1 study evaluated the pharmacokinetics and safety of murepavadin, a novel peptide antibiotic for the treatment of serious Pseudomonas aeruginosa infections.
Summary · context
All subjects received a single 2.2-mg/kg of body weight intravenous infusion of murepavadin administered over 3 h.
Report a problemFND-3001275603
04HumanNon-randomized trialPharmacokinetics
In subjects with declining renal function, murepavadin half-life prolonged up to 24 h versus 7.7 h with normal renal function.
In plain wordsIn people with renal impairment, murepavadin half-life extended up to 24 h versus 7.7 h with normal renal function.
Peptide
Murepavadin
Outcome
IncreaseTerminal elimination half-life
Study
n = 32
Comparator
Normal renal function
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
2.2 mg/kg · intravenous infusion · single dose over 3 hAs given in this study (human).
Measurements
Half-life
≤ 24 h
Renal impairment, up to, with decreasing renal function
Half-life
7.7 h
Normal renal function
Source sentences
Summary
Accordingly, the terminal elimination half-life (t_1/2) prolonged up to 24 h with decreasing renal function compared to 7.7 h in subjects with normal renal function.
2 context sentences(design, population, supporting numbers)
Summary · context
This open-label, nonrandomized, single-dose, phase 1 study evaluated the pharmacokinetics and safety of murepavadin, a novel peptide antibiotic for the treatment of serious Pseudomonas aeruginosa infections.
Summary · context
All subjects received a single 2.2-mg/kg of body weight intravenous infusion of murepavadin administered over 3 h.
Report a problemFND-3001275604
05HumanNon-randomized trialSafety outcome
In subjects across all renal function groups, murepavadin was well tolerated.
In plain wordsIn people across all renal function groups, murepavadin was well tolerated.
Peptide
Murepavadin
Outcome
Direction not reportedTolerability
Study
n = 32
Outcome group
Adverse events · Whole body
Studied dose
2.2 mg/kg · intravenous infusion · single dose over 3 hAs given in this study (human).
Source sentences
Summary
Murepavadin was well tolerated in all renal function groups.
3 context sentences(design, population, supporting numbers)
Summary · context
The study was conducted in 32 subjects of either sex in 4 groups (up to 8 per group) with mild (group 1), moderate (group 2), and severe (group 3) renal function impairment or with normal renal function (group 4).
Summary · context
This open-label, nonrandomized, single-dose, phase 1 study evaluated the pharmacokinetics and safety of murepavadin, a novel peptide antibiotic for the treatment of serious Pseudomonas aeruginosa infections.
Summary · context
All subjects received a single 2.2-mg/kg of body weight intravenous infusion of murepavadin administered over 3 h.
Report a problemFND-3001275605

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 1NCT02110459

Pharmacokinetics and Safety of POL7080 in Patients With Renal Impairment

Polyphor Ltd.n = 48Apr 2013 to Jul 2015

Renal Impairment

Trial page ClinicalTrials.govUpdated 17 Jun 2016

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
27 Oct 2026, 18:20 UTC
Study results updated
Version 1
27 Oct 2026, 16:32 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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