Phase I Clinical Trials
Phase I Clinical Trials are the first stage of testing in human subjects. Typically, a small group of 20 to 100 participants will be selected for the trial. This phase of the trials is designed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of a drug.
Phase I trials are often conducted in an inpatient clinic, whereas the subject can be observed by a full time staff. The subjects receiving the drug is usually observed until several half-lives of the drug have passed. Phase I trials typically include dose-ranging studies, also referred as dose escalation, in order that the appropriate dose for therapeutic use can be found. The tested range of doses will usually be a fraction of the dose that causes harm in animal testing.
Phase I trials typically use healthy participants. However, there are circumstances when real patients are used, for example, patients who have HIV, terminal cancer or other illnesses with limited treatment options. Volunteers are paid a fee for their time spent in the volunteer center. Payment can range from a small amount of money for a short period of residence, to a larger amount of up to $6000 depending on length of participation.
There are Different Kinds of Phase I Trials:
SAD
Single Ascending Dose studies are those in which small groups of subjects are given a single dose of the drug while they are observed and tested for a period of time. If they do not exhibit any adverse side effects, and the pharmacokinetic data is roughly in line with predicted safe values, the dose is escalated, and a new group of subjects is then given a higher dose. This is continued until pre-calculated pharmacokinetic safety levels are reached, or intolerable side effects start showing up (at which point the drug is said to have reached the Maximum tolerated dose (MTD).
MAD
Multiple Ascending Dose studies are conducted to better understand the pharmacokinetics & pharmacodynamics of multiple doses of the drug. In these studies, a group of patients receives multiple low doses of the drug, while samples (of blood, and other fluids) are collected at various time points and analyzed to understand how the drug is processed within the body. The dose is subsequently escalated for further groups, up to a predetermined level.
Food Effect
A short trial designed to investigate any differences in absorption of the drug by the body, caused by eating before the drug is given. These studies are usually run as a crossover study, with volunteers being given two identical doses of the drug on different occasions; one while fasted, and one after being fed.
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