Phase I - Types of Studies for Healthy Volunteers
Clinical trials in Phase I are used to determine the safety, tolerability, and pharmacokinetics (how your body absorbs, metabolizes, and excretes) of a drug.
There are a variety of study types that are conducted at our clinics. Sometimes, a study is a combination of multiple study types. These study types include;
- The rate and extent to which a drug is absorbed or is otherwise available to the treatment site in the body.
- Drugs with the same active ingredient(s) are compared at the same dosage under similar conditions.
- A modification of the effect of a drug when administered with another drug. Drugs with the same active ingredient(s) are compared at the same dosage under similar conditions.
- The first Phase I study in which the test product is administered to human beings. These usually have a small group dosed followed by a larger group after safety is assessed.
- Single Ascending Dose: subjects are dosed in small groups. Each member of the group will receive either the drug or placebo. The first group will start with a very low dose, each following group will receive an escalated dose depending on the safety and tolerability of the drug. The dose escalation will stop once maximum tolerability and/or safety has been reached.
- Multiple Ascending Dose: Similar to ascending except subjects will receive multiple doses of the drug or placebo instead of just one.
- Assessing the effects of food on the rate of absorption of a drug when the drug product is administered shortly after a meal as compared to fasted conditions.
- Studies the biochemical and physiologic effects of the drug
- Desired activity (Main use of drug)
- Undesirable effects
- Therapeutic window
- Duration of action of the drug on the body
- Assessing the body’s absorption, distribution, metabolism, and excretion of the drug. In other words, how your body affects the drug.
- The QT interval is a measure of the time between the start of Q wave and the end of the T wave in the hearts electrical cycle. QT studies assess the drug’s effect on the QT interval under a strictly controlled environment. To analyze the affects, frequent electrocardiogram (ECG) recordings are collected to monitor QT changes.
- These studies assess radioactivity levels through absorption, metabolism, and excretion. These components are measured through collection of blood, fecal, and urine samples.
- Read more on Radiolabeled AMEs
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