CCT EDD Research Services include:
GENERAL PHASE I EDD
BRIDGING STUDIES
DYNABRIDGING STUDIES
ETHNIC SENSITIVITY / ETHNOBRIDGING (learn more)

General Phase I EDD
As your dedicated partner in providing valuable research, we want you to get drugs to market quickly. Our Phase I services include:

• Discovery and Experimental Medicine
• Definitive Cardiac QTc Study in patients
• Traditional Phase I studies in special populations, patients, and healthy normal volunteers. Includes PK Studies such as bioequivalence, drug-drug interactions, food-drug interactions and more
• Scientific Support services, such as protocol development, assistance with IND filing, and connecting cutting-edge technology providers with Sponsors
• Real-time communications including regularly scheduled conference calls between the Sponsor and the CCT research team

We specialize in conducting studies that incorporate:

• Surrogate marker evaluations
• Proof of principle and concept trials
• Proof of CNS penetration
• Dose-response relationship determinations in target populations
• Full PK/PD characterizations in plasma, urine, and CSF
• Polysomnography in a sleep center
• Safety/tolerability, optimal dosing schedules and MTD in target populations
• Intensive and Definitive cardiac safety (QTc) evaluations For whatever your Phase I needs, CCT is ready to help

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Bridging Studies
The Bridging Study, pioneered by CCT, is a pharmacokinetic study in the target patient population designed to determine the doses needed for the drug's intended use. These studies identify possible drug differences in the target population compared to healthy volunteers. They provide tremendous opportunity for surrogate marker evaluations and identity of true maximum tolerated dose (MTD).

Our work has been widely published in peer-reviewed pharmacology journals and presented in many textbooks (FUTURE link to publications and selective online PDFs). This technique has assisted Sponsors in saving many drugs after Phase II studies failed to demonstrate efficacy.

Pharmacodynamic and behavioral measures provide a glimpse into the efficacy and safety of the compound at the earliest possible stage of drug development. The bridging protocol also allows for a complete evaluation of all potential doses.. CCT can conduct Bridging Studies as the first multiple ascending dose study, thereby providing a shortcut to Phase II.

Our therapeutic areas of expertise include, but are not limited to:

• Alzheimer's disease
• Affective disorders
• Anxiety disorders
• Migraine
• Parkinson's disease
• Schizophrenia
• Sleep disorders

Sponsors can confidently make early and accurate decisions to accelerate and prioritize the drug's development or terminate compound development prior to expensive multi-center Phase II trials. Many Sponsors take advantage of our bridging techniques to make informed, critical decisions that save them both time and money.

Contact us for additional information on CCT's Bridging Study.

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Dynabridging Studies
Available only at CCT, dynabridging studies are PK/PD studies that use proprietary continuous or timed interval CSF sampling collection techniques. They measure drug, drug metabolites, surrogate biomarkers, and proteomic and genomic targets.

To facilitate early drug development CCT uses CSF measurements in both patients and in healthy volunteers, acetyl and butyl cholinesterase, prostaglandins, interleukins, soluble APP, beta Amyloid and other Alzheimer marker proteins, glycine, biogenic amines, and additional biomarkers. Changes in CSF parameters over the time frame of a single dosage interval can confirm target doses and provide corroborative evidence for drug action. Of particular current interest is the potential for psychotropic medications to modulate neuroprotective and anti-apoptotic proteins in the brain. CCT dynabridging can be used to prove once-daily dosing effectiveness, despite short plasma half-lives, and to test clinically useful titration dosing schemes.

Our CSF dynabridge technology can demonstrate proof of principle, as well as compare differential responses for patients and healthy volunteers. We can also recommend collaborators in academia that perform these advanced analyses, or work with your lab.

To contact us for more information on assistance with your study design.

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