Drug X is a poorly water soluble BCS/DCS II small molecule drug. In order to reduce the Cmax related side effects observed from the immediate release formulation, development of a modified release tablet was required.

Drug release from hyrdophillic matrix modified release tablets can be affected by various factors such as drug properties, molecular weight (or viscosity) and level of release controlling polymer, drug to polymer ratio (DPR), surface area to volume ratio (SAVR) and properties of filler.

Nolasiban is an orally active oxytocin receptor antagonist under development by ObsEva S.A to enhance the receptivity of the endometrium to embryo implantation. As part of the development program an open-labelled, two-part radiolabelled study was performed in female subjects. The study assessed the absorption and disposition of nolasiban after oral and intravenous (IV) administrations and enabled the determination of mass balance, routes and rates of excretion and metabolism, and absolute bioavailability.

IPK1 (receptor-interacting serine/threonine kinase 1) mediates cell survival through NF-kB, or cell death through apoptosis or necroptosis downstream of TNF receptor activation. R552 is a potent and selective RIPK1 inhibitor that has been shown to block inflammatory cell death (necroptosis). R552 is being developed for the treatment of autoimmune and inflammatory disorders. Preclinical data suggested that solubility may limit exposure; alternative formulations were also assessed in this first-in-human (FIH) study.

One of the crucial requirements of the principles of Good Clinical Practice (GCP) is the need to ensure the integrity and secure retention of clinical trial documents and records for a period of time determined by legal, country regulations and business requirements. Essential documents serve to demonstrate the compliance of the investigator, sponsor, and Clinical Research Organization (CRO) with the standards of GCP, protocol, procedures and with all applicable regulatory agencies.

The purpose of this study is to analyze pharmaceutical and clinical data from multiple development programs to understand the drivers and outcomes of selecting and dosing different lipid formulations.

This study assessed the contribution of CYP2D6 to the metabolization of idalopirdine by comparing pharmacokinetics in CYP2D6 extensive metabolizers (EM) and poor metabolizers (PM) following multiple oral dosing. Comparison of pharmacokinetic (PK) parameters in PMs and EMs may substitute for an interaction study of the effect of CYP2D6 inhibition.

A Phase 1, Randomized, Double-Blind, PlaceboControlled, First-in-Human Study to Assess Safety, Tolerability & Pharmacokinetics (PK) of Amilo-5MER in Healthy Volunteers

"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.