Question

Which of the following is false concerning a radiolabeled drug disposition study in humans?

Group of answer choices

a. May lead to separate toxicology studies on a drug metabolite if exposure to that metabolite during administration of the parent drug is much lower in animal toxicology studies than in human clinical trials.

b. Does not need to be conducted until after pivotal Phase 3 clinical trials are completed.

c. Identifies major routes of drug elimination in humans.

2. We are interested to investigate in a clinical trial whether a new diet plus exercise regimen can be used to manage hyperlipidemia as effective (non-inferior) as one of the lipid lowering agents (statins). Which of the following is NOT true?

Group of answer choices

a. The primary analysis will be performed on “intention to treat” basis

b. Subjects with hyperlipidemia (a total cholesterol level greater than or equal to 240 mg/dL) will be randomized in 1:1 ratio to either pravastatin or placebo + diet +exercise regimen

c. The study will utilize two-arm parallel group design

d. The study will be powered for efficacy (primary endpoint) but not safety

e. Two sample t-test will be used to test the null hypothesis of no difference in total cholesterol between the two treatment arms after 6 months of treatment

f. The primary endpoint is the total cholesterol level measured after 4 weeks of treatment

Answer 1

The FALSE statement in the first question is:

b. Does not need to be conducted until after pivotal Phase 3 clinical trials are completed.

The radiolabeled drug disposition studies, also known as ADME (Absorption, distribution, metabolism, and excretion) are frequently conducted in Phase 1 in order to avoid costly failures once the clinical trials are more advanced, by early increasing the knowledge of the pharmacological effects of an investigational drug in the human body.