The purpose of First-In-Human (FIH) trials is to study the human pharmacology, pharmacokinetics (PK) and pharmacodynamics (PD), tolerability, and safety of an investigational medicinal product (IMP) having already gone through preclinical studies, and to evaluate how the effects translate from animals to humans. They allow sponsors to determine potential risks associated to the drug at each step of its development and determine the safe dose range in the course of its clinical progression.

In this issue of The Altascientist, we discuss:

• Advantages of working with one CRO from preclinical to clinical
• Key aspects in designing a successful FIH trial
• The importance of having quick access to special and patient populations
• How adaptive trial designs in FIH studies can save drug developers significant time and millions in program costs
• Case study: Adaptive, FIH trial to assess safety, tolerability, PK, and food effect of single and multiple ascending doses (SAD/MAD) of a novel small molecule

Altasciences has designed and conducted a large number of renal and hepatic impaired studies and provides a flexible approach that allows for customization depending on your unique study needs. We partner with leading external sites to ensure that our renal and hepatic impaired patients have the specialized clinical oversight needed, and we leverage their databases to ensure we access the patient populations your studies require.

Altasciences' clinical pharmacology services involving patients and special populations include a scientific/medical and operational set-up that enables us to perform studies within one of our own Phase I/II centers or in collaboration with an extensive network of investigators. Over the past 25 years, our approach has demonstrated proven advantages and has resulted in delivery of faster and better patient pharmacology data to our clients.

Recruitment

Altasciences has a full-time, in-house recruitment team and call centers at each of their clinical facilities. We design effective and efficient recruitment strategies to reliably meet your targeted milestones. We keep up with constantly changing web technologies and look for new ways to connect and interact with our participants. The strategic use of online media allows us to target segments to a specific demographic.

Our online participant portal is unique in the industry. Participants can schedule a screening appointment for studies that match their profile, track screening results, and confirm their presence for the start of a trial. We also have a robust relationship management system that allows us to reach out to a targeted list of participants with our database throughout a study's progress.

Phase I/II Capabilities

Altasciences partners with local research teams and hospitals to expand our Phase I/II capabilities.

We offer a flexible set-up that allows us to identify the appropriate operational strategy according to project-specific requirements. We create tailor-made solutions based on three core elements:

• Altasciences' Phase I/II Centers: Study performance in one of our own Phase I centers in Kansas City or Montreal.
• Altasciences – hospital relationships: Altasciences medical and clinical operational staff supports study conduct at external hospitals thereby enabling a Phase I/II setting at sites with direct access to patient populations.
• Altasciences-managed sites: Management of independent specialized investigational sites in North America.

Altasciences has conducted over 40 HAP studies since 2008 and has been awarded repeated multi-year contracts with the NIH and the FDA. Our

studies evaluate the safety of both New Chemical Entities (NCEs) that are CNS-active, chemically or pharmacologically similar to other drugs with known abuse potential, or produce psychoactive effects such as sedation or euphoria. We also evaluate the effectiveness of abuse-deterrent formulations (ADFs) to assess the ability of the new formulation to be tampered with and abused. Well-controlled studies are critical in ensuring effective scheduling decisions for NCEs and labeling claims for ADFs.

Our fully integrated offering includes comprehensive

clinical studies in healthy normal human volunteers and patient populations. Our specially designed smoking rooms also allow for the controlled evaluation of abuse potential for tobacco and nicotine products.

Sponsors choose Altasciences as their preferred partner for HAP and ADF studies because of our unique expertise:

If you have questions on your HAP or ADF studies, our experts will be happy to chat with you and guide you in the best strategic approach for your drug development program.

Contact us