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CompletedNCT06092931Updated Jan 11, 2024

A Drug-Drug Interaction Study Evaluating the Perpetrator Potential of DC-806 on Cocktails of CYP450 Enzyme and Transporter Substrates in Healthy Participants

A Phase 1 interventional study of DC-806 and Midazolam in Healthy Participants, sponsored by DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-11.

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 Nov 2023, 2 years 10 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
28
Allocation
Non-randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

The main objective of this study is to assess the effect of DC-806 on the pharmacokinetics (PK) of cytochrome 3A4 (CYP3A4) substrate, midazolam and its active metabolite, 1-hydroxymidazolam, cytochrome 2C8 (CYP2C8) substrate repaglinide, P-glycoprotein (P-gp) transporter substrate digoxin, and breast cancer resistant protein (BCRP)/ organic anion transporter protein-1B1 (OATP1B1) transporter substrate rosuvastatin in healthy participants.

02

Conditions studied

  • Healthy Participants

Keywords

  • DC-806
  • Drug-drug interaction
  • Midazolam
  • Repaglinide
  • Digoxin
  • Rosuvastatin
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
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Sex: male or female; females must be of nonchildbearing potential, or postmenopausal.
  2. Age: 18 to 55 years, inclusive, at screening.
  3. Body mass index: 18.0 to 32.0 kg/m\^2, inclusive, at screening.
  4. Weight: ≥50 kg at screening.
  5. Status: healthy participants.
  6. At screening, females must be of nonchildbearing potential (defined as at least 12 consecutive months with no menses prior to screening, a serum follicle-stimulating hormone test to confirm postmenopausal status, or being surgically sterilized); nonpregnancy will be confirmed for all females by a serum pregnancy test conducted at screening, and by a urine pregnancy test at admission and at follow-up.
  7. Male participants, if not permanently surgically sterilized, must inform all sexual partners of their participation in a research study and agree to use a highly effective method of contraception and not donate sperm from admission to the clinical site until 30 days after the last study drug administration.
  8. All prescribed medication must have been stopped at least 14 days prior to admission to the clinical site.
  9. All over-the-counter medication, vitamin preparations and other food supplements, or herbal medications (e.g., 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. Occasional use of acetaminophen/paracetamol (e.g., up to 2 grams per day) is permitted during this period and throughout the study.
  10. Ability and willingness to abstain from alcohol-, caffeine-, and methylxanthine- containing beverages or food (e.g., coffee, tea, cola, chocolate, energy drinks) from 48 hours (2 days) prior to admission to the clinical site and during confinement at the clinical site.
  11. Willingness to abstain from any strenuous physical exercise from 96 hours (4 days) prior to admission and during confinement at the clinical site.
  12. Good physical and mental health on the basis of medical history, physical examination, clinical laboratory assessments, 12-lead electrocardiograms, 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 Contract Research Organization or the Sponsor.
  2. History of relevant drug and/or food allergies, in the opinion of the Investigator.
  3. Females who are currently breastfeeding.
  4. Smoking more than 5 cigarettes, 1 cigar, or 1 pipe daily within 3 months prior to screening.
  5. Unwilling or unable to abstain from tobacco products within the 48 hours (2 days) prior to admission 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.
  8. History within the previous 12 months of alcohol consumption exceeding 2 standard drinks per day on average. Alcohol consumption will be prohibited 48 hours prior to admission to the clinical site and during confinement at the clinical site.
  9. Positive screen for hepatitis B surface antigen, hepatitis C virus antibodies, or human immunodeficiency virus 1 and 2 antibodies.
  10. Consumption of any nutrients known to modulate CYP450 enzymes activity (e.g., grapefruit or grapefruit juice, pomelo juice, star fruit, or Seville [blood] orange products) within 14 days prior to the first administration of study drug and during the study (including washout period/clinic furlough until after discharge in the last study period).
  11. 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.
  12. History of donation of more than 450 mL of blood within 60 days prior to dosing in the clinical site or planned donation before 30 days has elapsed since intake of study drug.
  13. Plasma or platelet donation within 7 days of dosing and through follow-up.
  14. Significant and/or acute illness within 5 days prior to study drug administration that may impact safety assessments, in the opinion of the Investigator.
  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
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    Cohort 1: DC-806 + Midazolam (CYP3A4 substrate) + Repaglinide (CYP2C8 substrate)

    Participants will receive a single oral dose of the 2-probe substrate cocktail (midazolam and repaglinide) on Day 1. From Day 4 through Day 8, participants will receive twice-daily (BID) oral doses of DC-806 and a single oral dose of the 2-probe substrate cocktail on Day 7. DC-806 BID dosing will continue until the end of Day 8.

    Drug: DC-806 · Drug: Midazolam · Drug: Repaglinide

  • Experimental
    Cohort 2: DC-806 + Digoxin (P-gp substrate) + Rosuvastatin (BCRP/OATP1B1 substrate)

    Participants will receive a single oral dose of the 2-probe substrate cocktail (digoxin and rosuvastatin) on Day 1. From Day 5 through Day 9, participants will receive twice daily oral doses of DC-806 and a single oral dose of the 2-probe substrate cocktail on Day 8. DC-806 BID dosing will continue until the end of Day 9.

    Drug: DC-806 · Drug: Digoxin · Drug: Rosuvastatin

Interventions

  • DrugDC-806

    Oral tablets

  • DrugMidazolam

    Oral syrup

  • DrugRepaglinide

    Oral tablets

  • DrugDigoxin

    Oral tablets

  • DrugRosuvastatin

    Oral tablets

06

What researchers measure

Primary outcomes

  1. Cohort 1: Maximum Observed Plasma Concentration (Cmax) of Midazolam

    Time frame: Day 1 and Day 7

  2. Cohort 1: Cmax of 1-hydroxymidazolam

    Time frame: Day 1 and Day 7

  3. Cohort 1: Cmax of Repaglinide

    Time frame: Day 1 and Day 7

  4. Cohort 2: Cmax of Digoxin

    Time frame: Day 1 and Day 8

  5. Cohort 2: Cmax of Rosuvastatin

    Time frame: Day 1 and Day 8

  6. Cohort 1: Area Under the Plasma 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 Midazolam

    Time frame: Days 1-3 and Days 7-9

  7. Cohort 1: AUC0-t of 1-hydroxymidazolam

    Time frame: Days 1-3 and Days 7-9

  8. Cohort 1: AUC0-t of Repaglinide

    Time frame: Days 1-3 and Days 7-9

  9. Cohort 2: AUC0-t of Digoxin

    Time frame: Days 1-5 and Days 8-12

  10. Cohort 2: AUC0-t of Rosuvastatin

    Time frame: Days 1-5 and Days 8-12

  11. Cohort 1: AUC from Time 0 to Infinity (AUC0-inf) of Midazolam

    Time frame: Days 1-3 and Days 7-9

  12. Cohort 1: AUC0-inf of 1-hydroxymidazolam

    Time frame: Days 1-3 and Days 7-9

  13. Cohort 1: AUC0-inf of Repaglinide

    Time frame: Days 1-3 and Days 7-9

  14. Cohort 2: AUC0-inf of Digoxin

    Time frame: Days 1-5 and Days 8-12

  15. Cohort 2: AUC0-inf of Rosuvastatin

    Time frame: Days 1-5 and Days 8-12

Secondary outcomes

  1. Cohorts 1 and 2: Number of Participant who Experience an Adverse Event

    Time frame: Up to a maximum 22 days

07

Study locations

1 site
  • ICON Phase 1 Clinic
    Salt Lake City, Utah 84124, United States
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 Jan 11, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06092931
Lead sponsor
DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company
Responsible party
Sponsor
First posted
Oct 23, 2023
Start date
Oct 16, 2023
Primary completion
Nov 28, 2023
Completion
Nov 28, 2023
Last update
Jan 11, 2024

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 Jan 2024. You cannot join it, but the record below documents what was studied.

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