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Food Effect Related information

Phase I Healthy Volunteers

FIH (First-in-Human), SAD/MAD Trials

As a global CRO with over 35 years of experience in conducting FIH studies, Biotrial has a team of experienced early-phase study experts, who are well-versed in the design, conduct, and interpretation factors.

We have conducted FIH studies for a wide range of drugs, including small molecules, biologics, and gene therapies as well as in a variety of therapeutic areas, including oncology, cardiovascular disease, and neurodegenerative disorders.

Our phase 1 units in the US and France are located close to nearby hospital sites, which allows us to quickly and easily access medical care, equipment, and KOLs.

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Several early investigations can be conducted, as stand-alone or combined protocols such as:

  • Dose effect assessments
    • Single Ascending Dose (SAD)
    • Multiple Ascending Dose (MAD)
  • Evaluation of food (FE)
  • Drug-Drug Interaction (DDI) and drug-alcohol interactions
  • Combined complex adaptive trials can be conducted under one protocol, such as SAD-MAD+FE/DDI/QT/POC/specific populations (age, gender)
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Food Effect (FE)

Food effect studies are essential to understanding how food affects the absorption, distribution, metabolism, and excretion of orally administered drugs. Biotrial has a team of experienced clinical pharmacologists who are experts in the design, conduct, and interpretation of FE studies.

Our FE studies are conducted in healthy volunteers under the supervision of experienced clinical trial pharmacologists. We use a variety of methods to assess the food effect of drugs, including:

  • Plasma concentration monitoring: We measure the concentration of the drug in the blood to track its absorption, distribution, metabolism, and excretion.
  • Urinary excretion: We collect and analyze urine samples to measure the amount of drug that is excreted in the urine.
  • Metabolism studies: We use in vitro and in vivo techniques to study how the drug is metabolized by the body.
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Drug-Drug Interaction (DDI) Studies

Mitigating the Risk of Harmful Drug Interactions

Patients often take more than one medication simultaneously, and these medications can interact with each other in ways that can be harmful to patients and can lead to decreased efficacy or increased toxicity.

Biotrial has extensive experience in designing and conducting DDI studies. We have a team of experts who have conducted studies for a wide range of drugs, including small molecules, biologics, and gene therapies in a variety of therapeutic areas, including oncology, cardiovascular disease, and neurodegenerative disorders.

Our DDI studies are conducted in healthy volunteers or patients following FDA and EMA guidance. We use a variety of methods to assess the drug’s potential, including:

  • Prospective DDI studies
  • P450 (CYP) enzyme index studies
  • Transporter-mediated DDIs
  • Cocktail studies

Our studies can identify potential DDIs early in the drug development process, develop strategies to mitigate the risk of DDIs and assess the safety and efficacy of drugs in different populations

Proof-of-concept (POC) Studies

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Proof-of-concept (POC) studies are essential for making timely “Go/No Go” decisions in the drug development process. Small and emerging biotech companies need prompt insights into their drug potential.

Biotrial has the expertise to conduct POC clinical trials with healthy volunteers and specific patient populations when there is no relevant model for healthy participants.

Our POC studies provide valuable information on the safety, tolerability, and efficacy of new drugs in early development. This information can be used to make informed decisions about whether to continue the development of a drug or to abandon it.

We have conducted POC studies in a variety of therapeutic areas (non-exhaustive list), including:

  • Central Nervous System (CNS): Alzheimer’s disease, Parkinson’s disease, schizophrenia, depression, and epilepsy.
  • Dermatology: Atopic dermatitis, psoriasis, and acne.
  • Metabolic disorders: Diabetes, obesity, and hypercholesterolemia.
  • Inflammation: Rheumatoid arthritis, asthma, and ulcerative colitis.

BA/BE/PK Trials

Bioavailability (BA) and bioequivalence (BE) studies ensure that new drugs are safe and effective. BA studies measure the rate and extent of absorption of a drug from a test formulation, while BE studies compare the BA of two different formulations of the same drug. Pharmacokinetic studies evaluate the pharmacokinetics of a drug, which is the way the drug is absorbed, distributed, metabolized, and excreted by the body.

Our operational capacity, including a 260-bed unit and scalable facilities, combined with our extensive database of volunteers, enables us to effectively conduct these trials. Our clinical staff is skilled at managing high volumes of PK samples, both for small and large molecules, in a secure and controlled environment and with the ability to accommodate rapid study start-up and execution, and timelines expedition when necessary.

Our BA, BE, and PK studies provide valuable information that can be used to ensure the safety and efficacy of each new treatment. 

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Pharmacodynamic (PD) Studies

Our Clinical Pharmacology Scientific Services are numerous given our focus on Early Clinical Development and Translational research. Some of the scientific services are listed below:

Cognitive Function Assessments, PSG, wake EEG, signal acquisition, data processing and interpretation, QTc – PK analysis (non-compartmental/compartmental), PK/PD modeling and simulations, dose selection, Imaging (PET, MRI, CT, Sonography), Hematology including coagulation and Platelet aggregation and numerous tests in different areas such as dermatology, ophthalmology, and gynecology.

Human models

CNS:

  • Panic attack (CCK challenge), GAD (CO2 model), sleep disorders/insomnia (noise)
  • Cognitive disorders (Scopolamine challenge), Schizophrenia (Ketamine challenge)
  • Daytime sleepiness (Sleep deprivation)

Others:

  • Respiratory challenges (e.g., capsaicin-induced cough)
  • Cutaneous (e.g., Histamine challenge)

Pain:

  • Acute (thermal, cold pressor)
  • Inflammatory (UV-induced erythema)
  • Neuropathic (capsaicin alone or with UV)

PD STUDIES

Cognition tests and models

Cognition tests and models are used to assess the impact of drugs on cognitive function. These tests measure a variety of cognitive abilities, such as attention, memory, and decision-making.

  • qEEG measures in high-frequency bands: qEEG measures the electrical activity of the brain in high-frequency bands. These bands are associated with cognitive functions such as attention and memory.
  • ERP: P300 or SART+P300: ERP measures the brain’s response to a stimulus. The P300 component of the ERP is associated with attention and memory.
  • Information processing tests: Information processing tests measure the speed and accuracy of information processing. These tests include the DSST, RVIP, Stroop Test, and Simon Task.
  • Attention/vigilance tests: Attention/vigilance tests measure the ability to pay attention and maintain focus over time. These tests include the CFF, SRT/CRT, DAT, PVT, CPT, TMT A and B, and DV.
  • Memory tests: Memory tests measure the ability to store and retrieve information. These tests include the SWM, NWM, LMT, and N-back.

PD STUDIES

Neuropsychiatric questionnaires

Neuropsychiatric questionnaires are used to assess the impact of drugs on mental health. These questionnaires measure a variety of mental health symptoms, such as depression, anxiety, and psychosis.

  • MINI (Mini International Neuropsychiatric Interview): The MINI is a brief diagnostic interview that can be used to assess a variety of mental health disorders.
  • MADRS (Montgomery & Asberg Depression Rating Scale): The MADRS is a scale that measures the severity of depression.
  • C-SSRS (Columbia Suicide Severity Rating Scale): The C-SSRS is a scale that measures the risk of suicide.
  • PANSS (Positive And Negative Symptom Scale): The PANSS is a scale that measures the severity of symptoms of schizophrenia.
  • BPRS (Brief Psychiatric Rating Scale): The BPRS is a scale that measures the severity of symptoms of a variety of mental health disorders.
  • STAI (State Trait Anxiety Inventory): The STAI is a scale that measures the severity of anxiety.
  • CDR (Clinical Dementia Rating Scale): The CDR is a scale that measures the severity of dementia.
  • NPI (Neuropsychiatric Inventory): The NPI is a scale that measures the severity of neuropsychiatric symptoms in patients with dementia.

Large & specific recruitment capabilities

Biotrial has a network of recruitment centers in Europe and the USA that are responsible for creating substantial active pools of volunteers. These centers are easily accessible via public transportation and major roadways, ensuring access to diverse populations.

We have specific systems in place to conduct generic recruitment and study-specific advertising, which prioritize subject safety and prevent dual enrollment. Ensuring the safety and well-being of our volunteers throughout their trial participation is one of our top priorities.

Biotrial’s recruitment centers have specific systems in place to prioritize subject safety and prevent dual enrollment such as : 

  • Screening volunteers
  • Monitoring volunteers
  • Reporting adverse events
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Added values

Hopital

STATE-OF-THE-ART FACILITIES

2 units (260 beds), Europe and USA based, located close to nearby hospitals

Avis Client

Experience

Dedicated staff with over three decades of experience in designing and conducting a broad range of clinical trials.

Circle

Full-Service Solutions

Scientific advice, Regulatory submissions, protocol development, Pharmacovigilance, Clinical and Medical monitoring, Core lab, Bioanalysis, Statistics, Clinical Study Report (CSR) writing…

Schedule

Quality & Timelines

We deliver high-quality services within tight timelines, leveraging our expertise to optimize study design and maintain rigorous quality standards.

Participate in a clinical trial

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