In short
Clinical trials of "[14C] DC-806" are studying how the body removes it, how it moves through the body, and how it is broken down. The trial data describe a Phase 1 study in healthy male participants, with goals focused on excretion, mass balance, and pharmacokinetics after a single oral dose.
Key points
- [14C] DC-806 is being studied in a Phase 1 trial in healthy male participants. The main goal is to understand excretion balance, pharmacokinetics, and metabolism after a single oral dose. The study measures how much is recovered in urine and feces, and it also checks blood and plasma levels over time. The trial was completed and enrolled 8 participants. This research is focused on drug handling in the body, not on treating a disease.
Trial overview
This clinical research studied [14C] DC-806 in a Phase 1 setting.
The trial focused on healthy male participants and looked at how the study drug was removed from the body after one oral dose.
The brief summary says the study aimed to assess the rate and routes of excretion, including mass balance, and to assess pharmacokinetics in whole blood and plasma.
Study design and participants
This was an interventional study, which means researchers gave the study drug and then measured the body’s response.
The trial enrolled 8 participants and was completed.
The treatment listed in the source data was oral DC-806 and oral [14C]-DC-806, given as a single dose in the study summary.
What was measured
The main outcomes included how much of the total radioactive material and DC-806 was recovered in urine and feces.
The study also measured pharmacokinetic values in whole blood and plasma, including Cmax (the highest level), tmax (the time to reach the highest level), kel (the rate of removal), t1/2 (half-life), and AUC (total exposure over time).
For DC-806, the study also listed CL/F and Vz/F, which are measurements used to describe how the body clears a drug and how it spreads in the body.
For total radioactive material, the study measured whole blood to plasma ratios for Cmax and AUC0-inf, which help compare levels in different blood samples.
Trial status and size
The study status was Completed.
The enrollment was small, with only 8 healthy male participants, which is typical for an early Phase 1 study focused on how the body handles a substance rather than on disease treatment.
Patient-friendly terms
Excretion balance means checking where the study material goes after dosing and how much leaves the body through urine and feces.
Pharmacokinetics means how the body absorbs, moves, and removes the study drug over time.
Metabolism means how the body changes the study drug into other substances called metabolites.
Healthy participants are people without the disease being studied, used here so researchers can see the drug’s basic behavior in the body.