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Healthy VolunteersPhase 1NCT06045000

Mass Balance and Pharmacokinetics (PK) of [14C]-DC-806 in Healthy Male Participants

A Phase 1 study testing DC-806 and [14C]-DC-806 in people with Healthy Volunteers, run by DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of this study is to investigate the rate and routes of excretion, including the mass balance, after single oral dose administration of DC-806 containing 3.7 MBq (100 μCi) of [14C]-DC-806 in urine and feces. Read more about this study

Who is it for?
Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
DC-806 and [14C]-DC-806
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteNetherlands
Study dates
14 Sep 2023to 2 Oct 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Sex: male.
  • Age: 18 years to 55 years, inclusive, at screening.
  • Body mass index: 18.0 kg/m^2, inclusive, at screening.
  • Weight: ≥50 kg at screening.
  • Status: healthy participants.
  • Participants must agree to use adequate contraception as described in the protocol and not donate sperm from admission to the clinical site on Day -1 until 90 days after study drug administration.
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  • All prescribed medication must have been stopped at least 14 days prior to admission to the clinical site on Day -1.
  • All over-the-counter medication, vitamin preparations and other food supplements, or herbal medications (eg, St John's wort) must have been stopped at least 7 days (or 5 half-lives for certain medications, whichever is longer) prior to admission to the clinical site on Day -1. Occasional use of acetaminophen/paracetamol (eg, up to 2 grams per day) is permitted during this period and throughout the study.
  • Ability and willingness to abstain from alcohol from 48 hours (2 days) prior to screening and admission to the clinical site (including the 24-hour stay, as applicable), and during confinement at the clinical site.
  • Ability and willingness to abstain from methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, and energy drinks), and grapefruit (juice) from 48 hours (2 days) prior to admission to the clinical site on Day -1, and during confinement at the clinical site.
  • Willingness to abstain from any strenuous physical exercise from 96 hours (4 days) prior to admission on Day -1 and during confinement at the clinical site.
  • Good physical and mental health on the basis of medical history, physical examination, clinical laboratory, 12-lead electrocardiogram, and vital signs, as judged by the Investigator.
  • Willing and able to sign the Informed Consent Form.

Who cannot join

  • Employee of ICON or the Sponsor.
  • History of relevant drug and/or food allergies, in the opinion of the Investigator.
  • Irregular defecation pattern (less than once per 2 days on average), in the opinion of the Investigator.
  • Smoking more than 5 cigarettes, 1 cigar, or 1 pipe daily.
  • Unwilling or unable to abstain from tobacco products within the 48 hours (2 days) prior to screening, admission on Day -1, and during confinement in the clinical site.
  • History of alcohol abuse or drug addiction (including soft drugs like cannabis products) within 1 year prior to screening.
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  • Positive drug and/or alcohol screen (opiates, methadone, cocaine, amphetamines [including ecstasy], cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants, and alcohol) at screening or admission to the clinical site on Day -1.
  • Average intake of more than 24 units of alcohol per week (clinical site standard: 1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits).
  • Positive screen for hepatitis B surface antigen, hepatitis C antibodies, or human immunodeficiency virus 1 and 2 antibodies.
  • Participation in a drug study within 30 days prior to study drug administration in the current study. Participation in 4 or more other drug studies in the 12 months prior to study drug administration in the current study.
  • Donation or loss of more than 450 mL of blood within 60 days prior to study drug administration. Donation or loss of more than 1.5 liters of blood in the 10 months prior to study drug administration in the current study.
  • Significant and/or acute illness within 5 days prior to study drug administration that may impact safety assessments, in the opinion of the Investigator.
  • For a study with a radiation burden of >0.1 mSv, the participant will be excluded if he participated in another study with a radiation burden of >0.1 mSv and ≤1 mSv in the period of 1 year prior to screening; a radiation burden of >1.1 mSv and ≤2 mSv in the period of 2 years prior to screening; a radiation burden of >2.1 mSv and ≤3 mSv in the period of 3 years prior to screening, etc.
  • Exposure to radiation for diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton [excluding spinal column]), during work, or during participation in a clinical study in the period of 1 year prior to screening.
  • Unsuitable veins for infusion or blood sampling as determined by the Investigator or study staff.
  • Any other condition or prior therapy that, in the Investigator's opinion, would confound or interfere with the evaluation of safety, tolerability, or PK of the study drug, interfere with study compliance, or preclude informed consent.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • ICON Phase 1 Clinic

    Groningen, 9728 NZ

Other trials in Netherlands

About this study

Official title: A Phase 1 Study to Assess the Excretion Balance, Pharmacokinetics, and Metabolism of [14C]-DC-806 in Healthy Male Participants

The primary objective of this study is to investigate the rate and routes of excretion, including the mass balance, after single oral dose administration of DC-806 containing 3.7 MBq (100 μCi) of [14C]-DC-806 in urine and feces.

Being tested
DC-806, [14C]-DC-806
Keywords
DC-806, Mass Balance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DC-806Drug

    Oral tablets

  • [14C]-DC-806Drug

    Oral capsules

Study groups in NCT06045000
Study groupRoleWhat they receive
[14C]-DC-806ExperimentalParticipants will receive a single oral dose of unlabeled DC-806 tablets followed by DC-806 capsule containing 3.7 MBq (100 μCi) of [14C]-DC-806 on Day 1.
Receives: Drug: DC-806; Drug: [14C]-DC-806

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Renal Clearance (CLr) of DC-806

    Measured: Day 1 to Day 11

  2. CLr of Total Radioactivity

    Measured: Day 1 to Day 11

  3. Cumulative Amount Excreted in Urine (Aeurine) of DC-806

    Measured: Day 1 to Day 11

  4. Aeurine of Total Radioactivity

    Measured: Day 1 to Day 11

  5. Percentage of the Dose Administered Excreted in Urine (Feurine) of DC-806

    Measured: Day 1 to Day 11

  6. Feurine of Total Radioactivity

    Measured: Day 1 to Day 11

  7. Cumulative Amount Excreted in Feces (Aefeces) of Total Radioactivity

    Measured: Day 1 to Day 11

  8. Cumulative Amount Excreted in Vomitus (Aevomitus) of Total Radioactivity

    Measured: Day 1 to Day 11

  9. Percentage of the Dose Administered Excreted in Feces (Fefeces) of Total Radioactivity

    Measured: Day 1 to Day 11

  10. Percentage of the Dose Administered Excreted in Vomitus (Fevomitus) of Total Radioactivity

    Measured: Day 1 to Day 11

  11. Total Amount Excreted in Urine, Feces, and Vomitus (Aeurine + Aefeces + Aevomitus) of Total Radioactivity

    Measured: Day 1 to Day 11

  12. Total Percentage of the Dose Administered Excreted in Urine, Feces, and Vomitus (Feurine + Fefeces + Fevomitus) of Total Radioactivity

    Measured: Day 1 to Day 11

  13. Maximum Observed Concentration (Cmax) of DC-806 in Whole Blood

    Measured: Day 1 to Day 11

  14. Cmax of DC-806 in Plasma

    Measured: Day 1 to Day 11

  15. Cmax of Total Radioactivity in Whole Blood

    Measured: Day 1 to Day 11

  16. Cmax of Total Radioactivity in Plasma

    Measured: Day 1 to Day 11

  17. Time to Cmax (tmax) of DC-806 in Whole Blood

    Measured: Day 1 to Day 11

  18. tmax of DC-806 in Plasma

    Measured: Day 1 to Day 11

  19. tmax of Total Radioactivity in Whole Blood

    Measured: Day 1 to Day 11

  20. tmax of Total Radioactivity in Plasma

    Measured: Day 1 to Day 11

  21. Area Under the Concentration-time Curve (AUC) up to Time t, where t is the Last Point with Concentrations Above the Lower Limit of Quantification (AUC0-t) of DC-806 in Whole Blood

    Measured: Day 1 to Day 11

  22. AUC0-t of DC-806 in Plasma

    Measured: Day 1 to Day 11

  23. AUC0-t of Total Radioactivity in Whole Blood

    Measured: Day 1 to Day 11

  24. AUC0-t of Total Radioactivity in Plasma

    Measured: Day 1 to Day 11

  25. AUC from time 0 to infinity (AUC0-inf) of DC-806 in Whole Blood

    Measured: Day 1 to Day 11

  26. AUC0-inf of DC-806 in Plasma

    Measured: Day 1 to Day 11

  27. AUC0-inf of Total Radioactivity in Whole Blood

    Measured: Day 1 to Day 11

  28. AUC0-inf of Total Radioactivity in Plasma

    Measured: Day 1 to Day 11

  29. Apparent Terminal Elimination Rate Constant (λz) of DC-806 in Whole Blood

    Measured: Day 1 to Day 11

  30. λz of DC-806 in Plasma

    Measured: Day 1 to Day 11

  31. λz of Total Radioactivity in Whole Blood

    Measured: Day 1 to Day 11

  32. λz of Total Radioactivity in Plasma

    Measured: Day 1 to Day 11

  33. Apparent Terminal Elimination Half-life (t1/2) of DC-806 in Whole Blood

    Measured: Day 1 to Day 11

  34. t1/2 of DC-806 in Plasma

    Measured: Day 1 to Day 11

  35. t1/2 of Total Radioactivity in Whole Blood

    Measured: Day 1 to Day 11

  36. t1/2 of Total Radioactivity in Plasma

    Measured: Day 1 to Day 11

  37. Apparent Total Clearance (CL/F) of DC-806 in Whole Blood

    Measured: Day 1 to Day 11

  38. CL/F of DC-806 in Plasma

    Measured: Day 1 to Day 11

  39. Apparent Volume of Clearance (Vz/F) of DC-806 in Whole Blood

    Measured: Day 1 to Day 11

  40. Vz/F of DC-806 in Plasma

    Measured: Day 1 to Day 11

  41. Cmax of Total Radioactivity Blood to Plasma Ratio

    Measured: Day 1 to Day 11

  42. AUC0-inf of Total Radioactivity Blood to Plasma Ratio

    Measured: Day 1 to Day 11

Secondary outcomes (2)

  1. Number of Participants who Experience an Adverse Event

    Measured: Up to a maximum of 25 days

  2. Plasma, Whole Blood, Urine, and Feces Concentrations of DC-806 Major Metabolites

    Measured: Day 1 to Day 11

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2023
  2. Study start14 Sep 2023
  3. Primary completion2 Oct 2023
  4. Study completion2 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06045000
Sponsor's protocol ID
DCE806102
Other IDs
2023-505367-36-00, J5B-MC-FHAF, 2023
Status last verified
May 2025
First submitted
13 Sep 2023
Last updated
4 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DC-806 and [14C]-DC-806 in people with Healthy Volunteers, run by DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Renal Clearance (CLr) of DC-806 (time frame: Day 1 to Day 11). The study lists 42 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06045000.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2025.

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