"A Phase 1, Randomized, Double-Blind, Placebo Controlled, First-in-Human Study to Assess Safety, Tolerability & Pharmacokinetics (PK) of Amilo-5MER in Healthy Volunteers." The poster was presented at the Pharmacology 2022 conference and was co-authored with our customer, Galmed Pharmaceuticals.

Quotient Sciences AAPS 2022 Poster, "Formulation and Taste Assessments in First in Human Studies" is available to download here.

Quotient Sciences AAPS 2022 Poster, "Kilo Scale Synthesis in Daisy Chained Flow Reactors." (2R, 6R) hydroxynorketamine is a pharmaceutical undergoing trials as an antidepressant. An atom-efficient synthesis route with norketamine as an intermediate is known. A low throughput flow synthesis route to norketamine had previously been developed, 2 however a manufacturing scale method was required. The objective of this study is to conduct the entire synthesis of norketamine from 2 chlorophenylcyclopentyl ketone in daisy-chained reactors, built mainly from readily available parts at a throughput of > 1 kg/day.

Benznidazole pharmacokinetics in adults and children: Application of PBPK modelling to explore the impact of age on benznidazole pharmacokinetics, presented at the American Conference on Pharmacometrics (ACoP) 2022. Download a copy of Quotient Sciences scientific poster on "Benznidazole pharmacokinetics in adults and children: Application of PBPK modelling" here.

Download Quotient Sciences poster on the 'Development of a novel oral suspension formulation of a candidate API for administration to pediatric patients'.

Quotient Sciences uses GastroPlus® PBPK modeling software to support clinical development decision-making

Quotient Sciences’ modeling & simulation team presented a scientific poster at PKUK 2022, detailing the qualification of GastroPlus® PBPK modeling software. The project aimed to validate the software’s predictive performance across diverse drug types, formulations, and clinical scenarios.

Using a repository of case studies, the team compared simulated pharmacokinetic outcomes with observed clinical data to assess model accuracy and precision. The results confirmed that GastroPlus® software can reliably predict real-world outcomes, making it a qualified platform for physiologically based pharmacokinetic modeling in drug development.

With modeling & simulation tools like GastroPlus® software, Quotient Sciences can offer data-driven formulation strategies that reduce development risk and support regulatory submissions. 

Download Quotient Sciences poster on 'A Phase I Study of the Cancer-specific Vaccine FMPV-1 in Healthy Male Subjects to Assess Safety and Immune Response'.

With a draft FDA guidance under review*, there is currently considerable interest in the design and conduct of human mass balance studies. 

In the last 10 years, Quotient Sciences have performed close to 200 radiolabelled human ADME studies. In that period, study designs have been adapted when required to address the challenges presented by new drug candidates, to benefit from new technologies and with a better understanding of how to interpret the data that can be generated from the analysis of collected samples in human ADME studies. 

This poster reviews some of the outcomes from those programs, which are conducted as part of clinical pharmacology services at Quotient Sciences. Presented as part of the 2022 The International Society for the Study of Xenobiotics (ISSX) conference in Seattle, WA, USA.

*Clinical Pharmacology Considerations for Human Radiolabelled Mass Balance Studies, FDA, May 2022

Masitinib is a treatment under development for neurology, inflammatory diseases, oncology, and viral infections.

In collaboration with AB Science, TNO, and Pharmaron, Quotient Sciences presented a scientific poster at ISSX 2022 detailing a human ADME study of Masitinib, an oral tyrosine kinase inhibitor targeting mast cells and macrophages. 

The open-label, radiolabeled study involved six healthy male volunteers who received a single oral dose of 14C-masitinib. Using accelerator mass spectrometry (AMS) and UPLC-HRMS, researchers assessed mass balance, routes of elimination, and metabolite profiling. 

Results showed 69% recovery of the radioactive dose, primarily through fecal excretion. Several metabolites were identified, and findings suggested possible covalent binding of masitinib metabolites to plasma proteins.

This study provides critical insights into Masitinib’s pharmacokinetics, supporting its regulatory strategy and further early clinical development.

Download the poster to see detailed findings from the ADME program.

Safety, tolerability, and pharmacokinetics of the oligomer modulator anle138b: a first-in-human randomized, double-blind, placebo-controlled Phase 1 trial.