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Phase I

Being focused on early clinical development, CRO is able to undertake the widest possible range of Phase I and Phase I/II type studies. It goes without saying that this includes routine PK work in healthy volunteers and other related studies, such as food-effect and drug-drug interaction studies. With a fully equipped GE MUSE network and the latest GE MAC systems, we are able to perform TQTc studies using our own validated resources, transferring data via the MUSE network to our own ECG core lab partners for evaluation. Alternatively, we can of course work with any ECG core lab of your choice.

We are also able to undertake exploratory Phase I type studies in patients and other special populations. The experience we bring to this pre-POC stage is extensive and includes work in Asthma, COPD, HIV, HCV, RA, Psoriasis, IBD, MS, Parkinson’s, Alzheimer’s, Schizophrenia, Diabetes, Hypertension and Heart Failure.

As with our FTIH work, we benefit from considerable internal expertise and resources. Once again we can supplement this with our ability to harness additional resources and expertise through our collaboration with Charité - Universitätsmedizin Berlin.

For instance, CRO operates one of the most modern respiratory function laboratories available. Facilities include body plethysmography, spiroergometry, exNO and allergen challenge, enabling us to routinely undertake complex asthma and COPD protocols using internal resources.

Our ability to integrate additional resources and expertise from within Charité - Universitätsmedizin Berlin can be witnessed in the elegant implementation of a healthy volunteer study utilizing expertise and diagnostics across the four distinct disciplines of neurology, ophthalmology, dermatology and hematology.

Summary

Healthy Volunteers

FTIH studies
SAD studies
MAD studies
Thorough QTc studies
PK / PD studies with inclusion of biomarkers and/or imaging
Interaction studies (e.g. Midazolam)
Food effect
Bioavailability / Bioequivalence studies

Special Populations

Hepatic impairment
Renal impairment (including renal replacement)
Genotyped subjects
Post menopausal women
Healthy elderly

Patients

Allergy & Respiratory

Mild, Moderate and Persistent Asthma
Mild, Moderate and Severe COPD
Allergic Asthma
Allergic Rhinitis
Dermatitis
Contact Allergies

Cardiovascular & Metabolic

Type I Diabetes
Type II Diabetes
Hyperlipidemia
Hypertension
Heart Failure
Obesity
Peripheral Arterial Disease

Infectious Diseases

Hepatitis C
HIV

Inflammation & Immunology

Inflammatory Bowel Disease
Innate Immunity
Multiple Sclerosis
Psoriasis
Psoriatic Arthritis
Rheumatoid Arthritis
Systemic Lupus Erythematosus

Neurosciences

Addition
Alzheimer’s
Anxiety
Chronic Depression
Epilepsy
Migraine
Multiple Sclerosis
Parkinson’s
Schizophrenia

Ophthalmology

Dry Eye Disease
Glaucoma
Macular Degeneration

Pain

Chronic Pain
Headache
Neuropathic Pain
Rheumatic Pain

Adaptive Design Studies

Phase I studies combining multiple parts and variable design elements can be undertaken. Such studies benefit from Charité Research Organisation’s experience in handling both ethics and regulatory submissions for such studies. For example, a Phase I PK/PD study in HCV patients in which early cohorts incorporated fixed 7 day dosing at specified levels, while the design of later cohorts was variable – foreseeing either 7 or 14 day dosing – and dependent on ongoing analysis of PK data and viral response seen in earlier cohorts.

PK/PD Studies

Phase I PK/PD studies can be undertaken in a range of populations. This could include healthy volunteers in which specific diagnostics are used to address changes that can equally be seen in this population or patients. Alternatively such studies could include patients in which specific diagnostics, biomarkers and clinical evaluations can be employed to evaluate changes in the patient. For example, a healthy volunteer study in which technologies and expertise across four disciplines was used to address a specific question.

Drug/Drug Interaction Studies

Classical studies evaluating interactions or assessing the impact of inhibitors or inducers are undertaken. For example, a multiple dose study investigating the impact of Midazolam on the pharmacokinetics of an investigational product.

Food Effect Studies

Food effect can be evaluated in classical stand alone studies, or by incorporating investigation of food effect into other studies.

Vaccine Studies

A wide range of prophylactic and therapeutic vaccine studies can be undertaken. These range from short duration FTIH and Phase I studies evaluating safety, tolerability and response over a limited time period (e.g. 28 days), through to longer duration (1-2 years) POC studies

Model Validation Studies

Charité Research Organisation is working with translational medicine groups to develop “model validation studies”. Such studies are designed to evaluate a particular model hypothesis, usually using licensed compounds. If successful such models and trial designs can subsequently be deployed in the development process for new investigational products.

TQTc Studies

Thorough QTc (TQTc) studies are undertaken as standalone studies or with intensive QTc evaluation incorporated into planned Phase I studies. CRO GE MAC550 equipment and MUSE network can be used to capture data and transfer it to the ECG CORE lab of choice (including CROs partner labs). Alternative, pre-validated ECG equipment supplied by the chosen CORE lab can be used.

Bioequivalence/Bioavailability Studies

Typical bioequivalence and bioavailability studies are undertaken. Where these studies are defined as “not time critical” they may become eligible to reduced rate pricing.

Nutritional Intervention Studies

Charité Research Organisation is able to utilize its extensive experience and resources to also services the needs of the functional food and nutrition market. CRO is able to design and undertake studies to help sponsors objectively evaluate health benefits in support of health claims applications with bodies such as EFSA. Such studies benefit extensively from CRO’s ability to access scientific knowledge to utilize extremely sensitive biomarkers and diagnostic technologies.

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