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CompletedNCT06045000Updated May 4, 2025

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

A Phase 1 interventional study of DC-806 and [14C]-DC-806 in Healthy Volunteers, sponsored by DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company. Completed at 1 site in Netherlands. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-04.

Sponsored by DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Primary completion was Oct 2023, 3 years ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Healthy Volunteers

Keywords

  • DC-806
  • Mass Balance
03

In context

Lead sponsor

DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company is the lead sponsor of 9 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 2 (22%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Sex: male.
  2. Age: 18 years to 55 years, inclusive, at screening.
  3. Body mass index: 18.0 kg/m\^2, inclusive, at screening.
  4. Weight: ≥50 kg at screening.
  5. Status: healthy participants.
  6. 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.
  7. All prescribed medication must have been stopped at least 14 days prior to admission to the clinical site on Day -1.
  8. 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.
  9. 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.
  10. 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.
  11. 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.
  12. 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.
  13. Willing and able to sign the Informed Consent Form.

Exclusion criteria

Exclusion Criteria:

  1. Employee of ICON or the Sponsor.
  2. History of relevant drug and/or food allergies, in the opinion of the Investigator.
  3. Irregular defecation pattern (less than once per 2 days on average), in the opinion of the Investigator.
  4. Smoking more than 5 cigarettes, 1 cigar, or 1 pipe daily.
  5. 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.
  6. History of alcohol abuse or drug addiction (including soft drugs like cannabis products) within 1 year prior to screening.
  7. 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.
  8. 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).
  9. Positive screen for hepatitis B surface antigen, hepatitis C antibodies, or human immunodeficiency virus 1 and 2 antibodies.
  10. 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.
  11. 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.
  12. Significant and/or acute illness within 5 days prior to study drug administration that may impact safety assessments, in the opinion of the Investigator.
  13. 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.
  14. 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.
  15. Unsuitable veins for infusion or blood sampling as determined by the Investigator or study staff.
  16. 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.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    [14C]-DC-806

    Participants 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.

    Drug: DC-806 · Drug: [14C]-DC-806

Interventions

  • DrugDC-806

    Oral tablets

  • Drug[14C]-DC-806

    Oral capsules

06

What researchers measure

Primary outcomes

  1. Renal Clearance (CLr) of DC-806

    Time frame: Day 1 to Day 11

  2. CLr of Total Radioactivity

    Time frame: Day 1 to Day 11

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

    Time frame: Day 1 to Day 11

  4. Aeurine of Total Radioactivity

    Time frame: Day 1 to Day 11

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

    Time frame: Day 1 to Day 11

  6. Feurine of Total Radioactivity

    Time frame: Day 1 to Day 11

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

    Time frame: Day 1 to Day 11

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

    Time frame: Day 1 to Day 11

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

    Time frame: Day 1 to Day 11

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

    Time frame: Day 1 to Day 11

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

    Time frame: Day 1 to Day 11

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

    Time frame: Day 1 to Day 11

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

    Time frame: Day 1 to Day 11

  14. Cmax of DC-806 in Plasma

    Time frame: Day 1 to Day 11

  15. Cmax of Total Radioactivity in Whole Blood

    Time frame: Day 1 to Day 11

  16. Cmax of Total Radioactivity in Plasma

    Time frame: Day 1 to Day 11

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

    Time frame: Day 1 to Day 11

  18. tmax of DC-806 in Plasma

    Time frame: Day 1 to Day 11

  19. tmax of Total Radioactivity in Whole Blood

    Time frame: Day 1 to Day 11

  20. tmax of Total Radioactivity in Plasma

    Time frame: 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

    Time frame: Day 1 to Day 11

  22. AUC0-t of DC-806 in Plasma

    Time frame: Day 1 to Day 11

  23. AUC0-t of Total Radioactivity in Whole Blood

    Time frame: Day 1 to Day 11

  24. AUC0-t of Total Radioactivity in Plasma

    Time frame: Day 1 to Day 11

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

    Time frame: Day 1 to Day 11

  26. AUC0-inf of DC-806 in Plasma

    Time frame: Day 1 to Day 11

  27. AUC0-inf of Total Radioactivity in Whole Blood

    Time frame: Day 1 to Day 11

  28. AUC0-inf of Total Radioactivity in Plasma

    Time frame: Day 1 to Day 11

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

    Time frame: Day 1 to Day 11

  30. λz of DC-806 in Plasma

    Time frame: Day 1 to Day 11

  31. λz of Total Radioactivity in Whole Blood

    Time frame: Day 1 to Day 11

  32. λz of Total Radioactivity in Plasma

    Time frame: Day 1 to Day 11

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

    Time frame: Day 1 to Day 11

  34. t1/2 of DC-806 in Plasma

    Time frame: Day 1 to Day 11

  35. t1/2 of Total Radioactivity in Whole Blood

    Time frame: Day 1 to Day 11

  36. t1/2 of Total Radioactivity in Plasma

    Time frame: Day 1 to Day 11

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

    Time frame: Day 1 to Day 11

  38. CL/F of DC-806 in Plasma

    Time frame: Day 1 to Day 11

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

    Time frame: Day 1 to Day 11

  40. Vz/F of DC-806 in Plasma

    Time frame: Day 1 to Day 11

  41. Cmax of Total Radioactivity Blood to Plasma Ratio

    Time frame: Day 1 to Day 11

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

    Time frame: Day 1 to Day 11

Secondary outcomes

  1. Number of Participants who Experience an Adverse Event

    Time frame: Up to a maximum of 25 days

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

    Time frame: Day 1 to Day 11

07

Study locations

1 site
  • ICON Phase 1 Clinic
    Groningen, 9728 NZ, Netherlands
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06045000
Lead sponsor
DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company
Responsible party
Sponsor
First posted
Sep 21, 2023
Start date
Sep 14, 2023
Primary completion
Oct 2, 2023
Completion
Oct 2, 2023
Last update
May 4, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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