Delving into the Latest Updates on Avibactam Tomilopil with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

CTB+AVP, PF-06264006+PF-07338233

+ [1]

Target

β-lactamase

Mechanism

β-lactamase inhibitors(Beta Lactamase inhibitors)

Therapeutic Areas

Infectious DiseasesUrogenital Diseases

Active Indication

Complicated urinary tract infection

Inactive Indication-

Originator Organization

Pfizer Inc.

Active Organization

Pfizer Inc.

Inactive Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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Structure

Molecular FormulaC14H23N3O8S

InChIKeyJHSLCXRZVJOZQZ-ZJUUUORDSA-N

CAS Registry2245880-46-8

An Interventional Open-Label, Single-Dose, 4-Treatment, 4-Period Crossover Study to Evaluate the Relative Bioavailability of CTB and AVI Administered Via Various Tablets or Capsule Formulations of PF-07612577 (PF-06264006 [CTB] - PF-07338233 [AVP]) and the Effect of Food on the Bioavailability of CTB and AVI Administered Via Tablets in Healthy Adult Participants

The purpose of this study is to learn about the study medicine CTB-AVP for the treatment of severe urinary tract infections that require hospitalization.
This study is seeking for:
* adult male and female participants who are healthy and weigh more than 50 kg.
* participants who have normal blood pressure, normal kidney and liver function
* participants willing to stay away from caffeine and other medicines for the duration of the study.
Participants will be required to stay in the study clinic for two weeks. All participants in this study will receive study medicine CTB-AVP by mouth one time each day on four different days. Study medicine will be given in capsules or tablets, on an empty stomach or will be taken with a meal. The study will look at the experiences of people receiving the study medicine. This will help determine if the study medicine is safe and effective.

Start Date29 Jul 2024

Sponsor / Collaborator

Pfizer Inc.

NCT05554237 / CompletedPhase 1

A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, SINGLE AND MULTIPLE-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-07612577 (PF-06264006 [CTB] + PF-07338233 [AVP]) IN HEALTHY ADULT PARTICIPANTS

The purpose of this clinical trial is to learn about the pharmacokinetics, safety and tolerability of various single- and multiple-doses of CTB+AVP in healthy adult participants. CTB+AVP is a study medicine that is being developed to treat people with complicated urinary tract infections.
This study is seeking healthy adult male and female participants, 18-60 years of age, with a body weight > 50 kg and a BMI of 17.5 to 30.5 kg/m2.
Participants in Part-1 of the study will receive increasing single doses of CTB and/or AVP. Participants in Part-2 will receive increasing multiple doses of CTB+AVP three times a day for 7 days. The study team will monitor how each participant is doing with the study treatments via close monitoring in an in-patient setting. Experiences of people receiving CTB+AVP will be compared to those of people who do not. This will help determine if CTB+AVP is safe and well-tolerated at each dose of the study medicine.
Participants will take part in this study for a maximum of 12 weeks for Part-1 (up to 4 weeks for screening, up to 3 weeks of taking study medicine and up to 5 weeks for safety follow-up visit) and for a maximum of 10 weeks for Part-2 (up to 4 weeks for screening, up to 1 week of taking study medicine and up to 5 weeks for safety follow-up visit). During the duration of the study, blood samples for study medicine levels, and various measures for monitoring safety such as blood samples for clinical laboratory measurements, electrocardiograms and vital sign measurements will be taken.

Start Date07 Oct 2022

Sponsor / Collaborator

Pfizer Inc.

ISRCTN10278402 / CompletedPhase 4IIT

Assessment of the effect of prior anthrax vaccine precipitated (AVP) vaccination on the immune response to booster AVP vaccination: an open-label trial

Start Date02 May 2009

Sponsor / Collaborator-

100 Clinical Results associated with Avibactam Tomilopil

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100 Translational Medicine associated with Avibactam Tomilopil

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100 Patents (Medical) associated with Avibactam Tomilopil

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3,345

Literatures (Medical) associated with Avibactam Tomilopil

01 Aug 2024·Nature Reviews Endocrinology

Arginine vasopressin deficiency: diagnosis, management and the relevance of oxytocin deficiency

Review

Author: Atila, Cihan ; Refardt, Julie ; Christ-Crain, Mirjam

Polyuria-polydipsia syndrome can be caused by central diabetes insipidus, nephrogenic diabetes insipidus or primary polydipsia. To avoid confusion with diabetes mellitus, the name 'central diabetes insipidus' was changed in 2022 to arginine vasopressin (AVP) deficiency and 'nephrogenic diabetes insipidus' was renamed as AVP resistance. To differentiate the three entities, various osmotic and non-osmotic copeptin-based stimulation tests have been introduced in the past decade. The hypertonic saline test plus plasma copeptin measurement emerged as the test with highest diagnostic accuracy, replacing the water deprivation test as the gold standard in differential diagnosis of the polyuria-polydipsia syndrome. The mainstay of treatment for AVP deficiency is AVP replacement with desmopressin, a synthetic analogue of AVP specific for AVP receptor 2 (AVPR2), which usually leads to rapid improvements in polyuria and polydipsia. The main adverse effect of desmopressin is dilutional hyponatraemia, which can be reduced by regularly performing the so-called desmopressin escape method. Evidence from the past few years suggests an additional oxytocin deficiency in patients with AVP deficiency. This potential deficiency should be further evaluated in future studies, including feasible provocation tests for clinical practice and interventional trials with oxytocin substitution.

01 Jul 2024·Journal of Diabetes Science and Technology

An Augmented Vision of Our Medical and Surgical Future, Today?

Article

Author: Casini, Andrea ; Armstrong, David G ; Clerici, Giacomo ; Pillai, Anand ; Bazikian, Sebouh ; Armstrong, Alexandria A

Incorporating consumer electronics into the operating room, we evaluated the Apple Vision Pro (AVP) during limb preservation surgeries, just as we evaluated Google Glass and FaceTime more than a decade ago. Although AVP’s real-time mixed-reality data overlay and controls offer potential enhancements to surgical precision and team communication, our assessment recognized limitations in adapting consumer technology to clinical environments. The initial use facilitated intraoperative decision-making and educational interactions with trainees. The current mixed-reality pass-through resolution allows for input but not for highly dexterous surgical interactions. These early observations indicate that while AVP may soon improve aspects of surgical performance and education, further iteration, evaluation, and experience are needed to fully understand its impact on patient outcomes and to refine its integration into clinical practice.

01 Jul 2024·International Journal of Cardiology

The axillary vein puncture for implantable cardiac defibrillator implantation: 14 years of experience. Analysis of the results

Article

Author: Morani, Giovanni ; Pepe, Antonio ; Bolzan, Bruna ; Strazzanti, Mattia ; Berton, Giampaolo ; Ribichini, Flavio Luciano

BACKGROUNDAxillary vein puncture (AVP) is a valid alternative to Subclavan vein puncture for leads insertion in cardiac implantable electronic device implantation, that may reduce acute and delayed complications. Very few data are available about ICD recipients. A simplified AVP technique is described.METHODSAll the patients who consecutively underwent "de novo" ICD implantation, from March 2006 to December 2020 at the University of Verona, were considered. Leads insertion was routinely performed through an AVP, according to a simplified technique. Outcome and complications have been retrospectively analyzed.RESULTSThe study population consisted of 1711 consecutive patients. Out of 1711 patients, 38 (2.2%) were excluded because they were implanted with Medtronic Sprint Fidelis lead. Out of 1673 ICD implantations, 963 (57.6%) were ICD plus cardiac resynchronization therapy, 434 (25.9%) were dual-chamber defibrillators, and 276 (16.5%) were single-chamber defibrillators, for a total of 3879 implanted leads. The AVP success rate was 99.4%. Acute complications occurred in 7/1673 (0.42%) patients. Lead failure (LF) occurred in 20/1673 (1.19%) patients. Comparing the group of patients with lead failure with the group without LF, the presence of three leads inside the vein was significantly associated with LF, and the multivariate analysis confirmed three leads in place as an independent predictor of LF.CONCLUSIONAVP, according to our simplified technique, is safe, effective, has a high success rate, and a very low complication rate. The incidence of LF was exceptionally low. The advantages of AVP are maintained over time in a population of ICD recipients.

100 Deals associated with Avibactam Tomilopil

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Complicated urinary tract infection	Phase 1	BE	Pfizer Inc.	23 Sep 2022

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASN2020	Not Applicable	-	43	AVP use post DDKT	egtahiikvr(mlwwapsinz) = otxcafajan nypghtxsvh (fqokczakut ) View more	Positive	19 Oct 2020
ARVO2015	Not Applicable	-	-	PBS	piffypxvgo(baxztxfdis) = tawdavycbv mqyqrqskpj (soypstrxmq )	-	01 Jun 2015
				AVP	piffypxvgo(baxztxfdis) = xvuzubzlty mqyqrqskpj (soypstrxmq )
AAN2014	Phase 3	Acute migraine	223	AVP-825 22 mg	onbidwfynj(vlqabbbpai) = ldibdkqcqz yhkcfdbtpq (gluhrqyqvi ) View more	Positive	08 Apr 2014
				Placebo	onbidwfynj(vlqabbbpai) = stizfpvxap yhkcfdbtpq (gluhrqyqvi ) View more