General pharmacology and pharmacokinetics: phase 0 trial: practice question

A Pharmacology question in the style of the NEET PG paper. Answer it first, then read why the right option is right and why each of the others is wrong.

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Pharmacology · General pharmacology and pharmacokinetics: phase 0 trial

Sample item

A first-in-human study gives a very small, sub-therapeutic dose of a new compound to about ten volunteers to learn how it is absorbed and distributed, with no intention of showing a therapeutic or toxic effect. Which type of study is this?

Original practice item, not a recalled exam question. Nothing here is recorded.

The answer and the reasoning

D. Phase 0 (exploratory microdose) study

A phase 0 study uses a microdose, too small to cause pharmacological effects, to obtain early pharmacokinetic data in a few subjects. Phase I escalates the dose to find tolerability and safety. Phase IV follows a drug after marketing.

Option by option

  • A. Phase II proof-of-concept study

    Phase II tests efficacy in patients with the target disease.

  • B. Phase I dose-escalation safety study

    Phase I raises the dose stepwise to study safety and tolerability at pharmacologically active doses.

  • C. Phase IV post-marketing study

    Phase IV is post-marketing surveillance of an approved drug.

  • D. Phase 0 (exploratory microdose) study (correct)

    Correct. A sub-therapeutic microdose in a few volunteers defines phase 0.

Source note: Original NextPrep sample item — pending expert review. This item is original practice material awaiting independent expert review, so confirm important facts in a standard textbook.

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Questions about this Pharmacology question

What is the answer to this Pharmacology question?

The best answer is D, Phase 0 (exploratory microdose) study. A phase 0 study uses a microdose, too small to cause pharmacological effects, to obtain early pharmacokinetic data in a few subjects.

Why is "Phase II proof-of-concept study" not the answer?

Phase II tests efficacy in patients with the target disease.

Why is "Phase I dose-escalation safety study" not the answer?

Phase I raises the dose stepwise to study safety and tolerability at pharmacologically active doses.

Why is "Phase IV post-marketing study" not the answer?

Phase IV is post-marketing surveillance of an approved drug.

What concept does this question test?

It tests General pharmacology and pharmacokinetics: phase 0 trial in Pharmacology. Phase I escalates the dose to find tolerability and safety. Phase IV follows a drug after marketing.

How hard is this question?

We tag it as an application question: it asks you to use a fact on a patient or a finding. The tag is our own editorial judgement, not an official difficulty rating, so read the reason for every option, not only the answer.

How should I study General pharmacology and pharmacokinetics: phase 0 trial?

Learn drugs as classes, then the exception in each class that an examiner would pick. Then use the flashcards and the other Pharmacology questions on this site to test what stuck.

Is this a real NEET PG question?

No. It is an original practice item (editorial status: sample, version 1). NextPrep does not publish recalled or leaked questions, and independent faculty review of this item has not been completed yet, so confirm important facts in a standard textbook.