Overview

Beside the respiratory expertise, INAMED is known for the planning and conduct of dedicated safety trials (e.g., FIM or cardiac safety trials), pharmacokinetic and pharmacodynamics trials in healthy subjects or patients, and clinical studies with complex endpoints such as Proof-of-Concept (PoC) trials. At our facilities in Munich-Gauting, highly-controlled clinical studies in early clinical development are conducted by a qualified team of several physicians and study nurses under the direction of a board-accredited clinical pharmacologist. Beyond this INAMED’s Clinical Operations Department is able to organize even large-scale, multicenter trials in collaboration with a well-established network of clinical experts, study monitors and experienced study sites. A highly qualified team of project managers, regulatory affairs managers, data managers and biostatisticians bring the scope of services offered by INAMED and its early-phase branch down to a round figure.

Early Phase Clinical Trials

The continuous monitoring of safety parameters (e.g., pulse rate, 3-lead ECG, oxygen saturation in peripheral blood) in combination with an alarm system and storage of data is nowadays mandatory for certain studies in early clinical development, e.g., First-in-Man (FIM) trials.

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FIM Trials as a very special type of early clinical safety trials are mentioned above, but there are more questions that might have to be answered in dedicated safety studies in healthy subjects or patients.

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Inamed’s clinical pharmacology experts and CU staff has a special expertise in conducting TQT trials. Background: A drug-induced delay in cardiac repolarisation can lead to cardia arrhythmia.

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The clinical facilities and infrastructure of Inamed’s clinical unit are appropriately staffed and equipped to conduct all kind of pharmacokinetic (PK) trials. Dedicated laboratory facilities, temperature-controlled working rooms, refrigerators and deep freezers connected with alarm systems and an emergency power generator are also available.

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DDI trials are special PK trials. Background: Drug-drug interactions can occur at any of the following levels: absorption, distribution, binding at the receptor, metabolization, or elimination. Clinically relevant interactions may occur as a result of induction or inhibition of an enzyme system by a certain drug, while another substrate is being metabolized via that enzyme system.

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In early clinical development, the term “large-scale trials” refers to mono-centre trials with a sample size of more than 80 subjects. The combination of Inamed’s in-house clinical unit with an outpatient clinic for ambulant visits and the company’s human resources pool allows the conduct of even large-scale trials within a reasonable period of time.

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Early Phase Clinical Trials in Patients

The first clinical trial in patients is always a safety study in a general sense. More specifically, a dedicated safety study in patients under highly controlled conditions may be required to investigate some special objectives.

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That kind of PK trials in patients is usually conducted to investigate whether the PK in patients is comparable to that in healthy subjects. Any differences in the pharmacokinetics of the investigational compound between patients and healthy subjects may either be caused by the pathophysiology of the disease, for example, in case of inflammation, or the metabolism or excretion of the study drug may be influenced by hepatic or renal impairment which is not the situation in healthy subjects.

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Proof-of-Concept trials in patients using adequate pharmacodynamic endpoints should not be initiated before an adequate phase-I program has been completed in healthy subjects and all safety and exposure data in healthy subjects have been thoroughly reviewed.

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Additional Services

In addition to the clinical trial services, Inamed's Clinical Operations Unit provides supportive services related to the conduct of clinical trials, such as protocol development, medical writing, evaluation and more.

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