Recommended Followup Testing for an Ames-Positive Drug (Active Ingredient) or Metabolite To Support First-in-Human Clinical Trials With Healthy Subjects

Issue Date: November 27, 2024
Issued by: Center for Drug Evaluation and Research
Topic(s): Pharmacology/Toxicology
Status: Draft

Recommended Followup Testing for an Ames-Positive Drug (Active Ingredient) or Metabolite To Support First-in-Human Clinical Trials With Healthy Subjects

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Recommended Followup Testing for an Ames-Positive Drug (Active Ingredient) or Metabolite To Support First-in-Human Clinical Trials With Healthy Subjects.” This draft guidance makes recommendations on followup testing for Ames-positive active ingredients in circumstances when a sponsor decides to continue development. The guidance recommends a consistent process of followup testing and evaluation that first should be conducted for an Ames-positive active ingredient before proceeding with first-in-human (FIH) trials in healthy human subjects. These recommendations are intended to potentially help address and lower safety concerns before proceeding with FIH trials in healthy human subjects.

Download the Guidance Document