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[14C] DC-806

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.

Table of contents

Trial overview

This clinical research studied [14C] DC-806 in a Phase 1 setting.[1]

The trial focused on healthy male participants and looked at how the study drug was removed from the body after one oral dose.[1]

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.[1]

Study design and participants

This was an interventional study, which means researchers gave the study drug and then measured the body’s response.[1]

The trial enrolled 8 participants and was completed.[1]

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.[1]

What was measured

The main outcomes included how much of the total radioactive material and DC-806 was recovered in urine and feces.[1]

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).[1]

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.[1]

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.[1]

Trial status and size

The study status was Completed.[1]

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.[1]

Patient-friendly terms

Excretion balance means checking where the study material goes after dosing and how much leaves the body through urine and feces.[1]

Pharmacokinetics means how the body absorbs, moves, and removes the study drug over time.[1]

Metabolism means how the body changes the study drug into other substances called metabolites.[1]

Healthy participants are people without the disease being studied, used here so researchers can see the drug’s basic behavior in the body.[1]

Trial IDPhaseCondition studiedStatusEnrollment
2023-505367-36-00Phase 1HealthyCompleted8

FAQ

  • What is being studied in the clinical trial of [14C] DC-806? The study is looking at excretion balance, pharmacokinetics, and metabolism after a single oral dose. In simple terms, it checks where the study drug goes in the body and how much leaves through urine and feces.
  • Who can take part in the trial? The trial enrolled healthy male participants. The source data do not describe other eligibility details.
  • What phase is the [14C] DC-806 trial? This is a Phase 1 trial. Phase 1 studies are early studies that often focus on how the body handles a drug rather than on treating a disease.
  • What condition is being studied? The condition listed is healthy, meaning the study was done in people without a disease condition in the trial record. The goal was to understand drug handling in healthy volunteers.
  • What results were measured in the study? The study measured how much of the drug and related material was recovered in urine and feces, plus blood and plasma measures such as peak level, time to peak, half-life, and total exposure. These are standard ways to describe how a drug is absorbed, moved, and removed.

Ongoing Clinical Trials on [14C] DC-806

  • A study to examine how the body processes and removes DC-806 in healthy male volunteers

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

Glossary

  • Phase 1: An early stage of clinical research. It usually looks at how the body handles a study drug and may include a small number of participants.
  • Healthy male participants: Men without the condition being studied in the trial record. They are often used in early studies to understand basic drug handling.
  • Excretion: The process of removing a substance from the body, mainly through urine or feces.
  • Mass balance: A way to measure how much of a dose is found in urine, feces, and other samples. It helps show where the drug goes after it is taken.
  • Pharmacokinetics: The study of how a drug moves through the body over time, including absorption, distribution, breakdown, and removal.
  • Metabolism: The body’s process of changing a substance into other compounds, called metabolites.
  • Urine recovery: The amount of study material found in urine after dosing.
  • Feces recovery: The amount of study material found in stool after dosing.
  • Cmax: The highest measured level of a drug in blood or plasma.
  • AUC: A measure of total drug exposure over time. It shows how much drug the body sees during the study period.
  • Half-life: The time it takes for the amount of a drug in the body to drop by half.

References

  1. https://clinicaltrials.gov/study/2023-505367-36-00