Solutions for Early Phase Challenges


Where our accuracy and speed meets your complex challenge…and wins

Early Clinical Development Solutions

Through our purpose-built clinics and concentration on new technologies and processes focused on assisting you, we are able to offer solutions across a broad range of therapeutic areas and specialty testing. Our experience in early phase clinical development ensures that there is not much we haven’t seen and conquered. We are ready to help you with your early phase challenges.

Celerion has developed specific expertise in several therapeutic indications that are commonly evaluated in early phase clinical studies in association with the drug under study. The specialty areas include: cardiovascular safety studies; respiratory studies; and metabolic studies. In addition to these, Celerion has developed specialty testing techniques and processes to handle your most complex early phase study requirements.

 


Human Radiolabeled ADME Studies

Celerion has the capabilities to manage all aspects of human radiolabeled ADME studies from synthesis and formulation of an appropriate radiolabeled drug through dosimetry assessment and clinical conduct to final isolation, identification and quantification of metabolites in the samples collected. Celerion has access to a skilled radiochemical synthesis group as well as to specialists in metabolite isolation and identification from biomatrices. Radiolabel dosage forms suitable for administration to humans can be readily prepared at Celerion’s purpose-built pharmacy clean room at our Lincoln facility. Our Lincoln clinic is one of the few global organizations that can conduct specialized human ADME studies to regulatory standards, including micro-radiotracer studies.

 


Ophthalmic Studies

In association with Queen’s University in Belfast, Celerion has expanded its expertise in performing precise ophthalmologic measurements as part of assessing the safety of new drug candidates. Moving beyond clinical safety assessment, we have the ability to focus on a variety of eye diseases such as diabetic retinopathy, age-related macular degeneration, glaucoma, and retinal vein occlusions.

Additionally, the evolution of accelerator mass spectrometry (AMS) applications in the life sciences over the past 10 years has driven new innovations in deploying very small doses of 14C-labeled drugs to answer key questions that often emerge during early clinical drug development. We have taken advantage of these innovations to deliver solutions to a variety of drug development challenges:

  • Assessment of absolute bioavailability for an oral drug:  micro tracer dose of intravenous radiolabeled drug given after administration of normal oral dose of cold drug.  AMS follows intravenous PK.  LCMS follows oral PK.
    • Eliminates the need to create GMP intravenous formulation and associated animal safety testing to get measure of absolute bioavailability
  • Assessment of ADME profile:  micro tracer dose added to cold dose provides answers to mass balance of drug elimination and metabolic profiles in excreta during the First-In-Human (FIH) studies
    • Provides evidence for MIST regulatory guidance
  • Assessment of distribution into human tissue fluids (e.g. CSF fluid for CNS, arthritic joint fluid, sputum/pulmonary lavage, saliva, tears, semen, milk, sweat)
    • Detects presence of drug/metabolites in tiny sample volumes or at low concentrations at or near site of drug action or to define potential exposure for assessment of human drug safety
  • Perform human ADME for long half-life drugs/metabolites by using micro tracer amounts as the standard mass balance radioactivity dose given is too high for healthy subjects
    • Avoids need for long-term confinements of study subjects
    • Allows for a safe dose of radioactivity
  • Obtain ADME information in patients who cannot be studied in a Phase I clinic
  • Low level radioactivity allows for dosing in a hospital or outpatient setting
  • Micro-dosing approach in getting early PK data under an Exploratory IND in the US (Phase 0 studies)
    • Ideal for selecting go-forward clinical drug from several candidates

Practical Regulatory Insight

Update and trends on pharmacokinetic studies in patients with impaired renal function

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