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A Bioequivalence Study Between the Proposed and Current Talazoparib Capsule Formulation and Food Effect Study for the Proposed Talazoparib Capsule Formulation in Participants With Advanced Solid Tumors

ABSTRACT: This will be a Phase 1, open label, 2-sequence, crossover study to establish the BE of the current commercial formulation (Generation 3.1 talazoparib capsules) to the proposed talazoparib liquid-filled soft gelatin capsule (soft gel capsule) formulation after multiple dosing under fasting conditions in participants with advanced solid tumors. In addition, the effect of food on the PK of the proposed talazoparib soft gel capsule formulation will be evaluated in fixed sequence after the 2 BE assessment periods.

DISEASE(S): Ovarian Cancer,Nsclc,Advanced Solid Tumors,Colorectal Cancer,Prostate Cancer,Pancreatic Cancer,Breast Cancer,Neoplasms,Solid Tumors

PROVIDER: 2361056 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Unraveling capsule biosynthesis and signaling networks in Cryptococcus neoformans

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Nitrogen source-dependent capsule induction in human pathogenic Cryptococcus species.

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Comparative genomic hybridization to study capsule switching between serogroup C and W of Neisseria meningitidis strains

Project description:Changing antigenic structure such as capsule polysaccharide is a common strategy for bacterial pathogen to evade host immune system. In this regard, the recent emergence of an invasive W:2a:P1.7-2,4 ST-11 strain in New Zealand, which is an uncommon pathogenic serogroup, was investigated for its genetic origins. Molecular typing of 103 meningococcal isolates with similar serotyping characteristics was undertaken to determine genetic relationships. Results indicated that the W:2a:P1.7-2,4 strain had emerged via capsule switching from an existing group C strain (C:2a:P1.7 2,4). Neither of the upstream and downstream sites of recombination could be elucidate but sequence analysis demonstrated that at least 45 kb of DNA was involved in the recombination event. This included the entire capsule gene cluster. Genomic DNA isolated from serogroup C strains (n=4) and serogroup W strains (n=4) were compared using Pan-neisseria DNA microarray.

2009-06-03 | E-MEXP-1910 | biostudies-arrayexpress

Nitrogen source-dependent capsule induction in human pathogenic Cryptococcus species.

2013-09-25 | E-GEOD-46829 | biostudies-arrayexpress

Expression analysis of Klebsiella pneumoniae MGH 78578 and capsule deletion mutant

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2013-12-31 | E-GEOD-40011 | biostudies-arrayexpress

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Expression analysis of Klebsiella pneumoniae MGH 78578 and capsule deletion mutant

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Toward an integrated model of capsule regulation in Cryptococcus neoformans

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2011-12-10 | E-GEOD-32228 | biostudies-arrayexpress

Genome-wide investigation of Pasteurella multocida identifies the stringent response as a negative regulator of hyaluronic acid capsule production

Project description:Pasteurella multocida is a Gram-negative capsulated bacterium responsible for a range of diseases that cause severe morbidity and mortality in livestock animals. The hyaluronic acid (HA) capsule produced by P. multocida serogroup A strains is a critical virulence factor. In this study, we utilised transposon-directed insertion site sequencing (TraDIS) to identify genes essential for in vitro growth of P. multocida, and combined TraDIS with discontinuous density gradients (TraDISort) to identify genes required for HA capsule production and regulation in this pathogen. Analysis of mutants with a high cell density phenotype, indicative of the loss of extracellular capsule, led to the identification of 69 genes important for capsule production. These genes included all previously characterized genes in the capsule biosynthesis locus, and fis and hfq that encode known positive regulators of P. multocida capsule. Many of the other capsule-associated genes identified in this study were involved in regulation or activation of the stringent response, including spoT and relA that encode proteins that regulate the concentration of guanosine alarmones. Disruption of the autoregulatory domains in the C-terminal half of SpoT using insertional mutagenesis resulted in reduced expression of capsule biosynthesis genes and an acapsular phenotype. Overall, these findings have greatly increased the understanding of hyaluronic acid capsule production and regulation in P. multocida.

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