Healthy ParticipantsPhase 1NCT06092931

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 study testing DC-806, Midazolam and Repaglinide in people with Healthy Participants, run by DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company at 1 site in United States.

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 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… Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Participants
What is being tested?: DC-806, Midazolam and Repaglinide
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteUnited States
Study dates: 16 Oct 2023to 28 Nov 2023
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Sex: male or female; females must be of nonchildbearing potential, or postmenopausal.
Age: 18 to 55 years, inclusive, at screening.
Body mass index: 18.0 to 32.0 kg/m^2, inclusive, at screening.
Weight: ≥50 kg at screening.
Status: healthy participants.
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.

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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.
All prescribed medication must have been stopped at least 14 days prior to admission to the clinical site.
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.
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.
Willingness to abstain from any strenuous physical exercise from 96 hours (4 days) prior to admission and during confinement at the clinical site.
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.
Willing and able to sign the informed consent form.

Who cannot join

Employee of Contract Research Organization or the Sponsor.
History of relevant drug and/or food allergies, in the opinion of the Investigator.
Females who are currently breastfeeding.
Smoking more than 5 cigarettes, 1 cigar, or 1 pipe daily within 3 months prior to screening.
Unwilling or unable to abstain from tobacco products within the 48 hours (2 days) prior to admission 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.
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.
Positive screen for hepatitis B surface antigen, hepatitis C virus antibodies, or human immunodeficiency virus 1 and 2 antibodies.
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).
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.
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.
Plasma or platelet donation within 7 days of dosing and through follow-up.
Significant and/or acute illness within 5 days prior to study drug administration that may impact safety assessments, in the opinion of the Investigator.
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.

United States1 site

ICON Phase 1 Clinic
Salt Lake City, Utah, 84124

Other trials in United States

About this study

Official title: A Phase 1, Single-Center, Open-Label, Fixed-Sequence Study to Evaluate the Effect of DC-806 on the Single Dose Pharmacokinetics of CYP450 Enzyme and Transporter Substrates in Healthy Participants

Conditions: Healthy Participants
Being tested: DC-806, Midazolam, Repaglinide, Digoxin, Rosuvastatin
Keywords: DC-806, Drug-drug interaction, Midazolam, Repaglinide, Digoxin, Rosuvastatin

What participants receive

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

DC-806Drug
Oral tablets
MidazolamDrug
Oral syrup
RepaglinideDrug
Oral tablets
DigoxinDrug
Oral tablets
RosuvastatinDrug
Oral tablets

Study groups in NCT06092931
Study group	Role	What they receive
Cohort 1: DC-806 / Midazolam (CYP3A4 Substrate) + Repaglinide (CYP2C8 Substrate)	Experimental	* Participants were administered a single oral dose of the 2-probe CYP substrate cocktail consisting of 2 milligram (mg) midazolam and 0.5 mg repaglinide under fasted conditions in the morning on Day 1. * From Days 4 through 8, participants received oral doses of 800 mg DC-806 twice daily. A single oral dose of 2-probe CYP substrate cocktail consisting of 2 mg midazolam and 0.5 mg repaglinide was co-administered under fasted conditions 1.5 hours after DC-806 dosing in the morning of Day 7. Receives: Drug: DC-806; Drug: Midazolam; Drug: Repaglinide
Cohort 2: DC-806 / Digoxin (P-gp Substrate) + Rosuvastatin (BCRP/OATP1B1 Substrate)	Experimental	* Participants were administered a single oral dose of the 2-probe transporter substrate cocktail consisting of 0.25 mg digoxin and 5 mg rosuvastatin under fasted conditions in the morning on Day 1. * From Days 5 through 9, participants received oral doses of 800 mg of DC-806 twice daily. A single oral dose of the 2-probe transporter substrate cocktail consisting of 0.25 mg digoxin and 5 mg rosuvastatin was co-administered under fasted conditions 1.5 hours after DC-806 dosing in the morning of Day 8. Receives: Drug: DC-806; Drug: Digoxin; Drug: Rosuvastatin

What is being measured

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

Cohort 1: Maximum Observed Plasma Concentration (Cmax) of Midazolam
The timepoints mentioned in the timeframe were relative to the administration of the 2-probe CYP substrate cocktail.
Measured: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours postdose on Days 1 and 7
Cohort 1: Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Time t, Where t is the Last Point With Concentrations Above the Lower Limit of Quantification (AUC0-t) of Midazolam
Cohort 1: AUC0-t of Midazolam. The timepoints mentioned in the timeframe were relative to the administration of the 2-probe CYP substrate cocktail.
Measured: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours postdose on Days 1 and 7
Cohort 1: AUC From Time 0 to Infinity (AUC0-inf) of Midazolam
The timepoints mentioned in the timeframe were relative to the administration of the 2-probe CYP substrate cocktail.
Measured: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours postdose on Days 1 and 7
Cohort 1: Cmax of 1-hydroxymidazolam
Cohort 1: Cmax of 1-hydroxymidazolam, an active metabolite of midazolam. The timepoints mentioned in the timeframe were relative to the administration of the 2-probe CYP substrate cocktail.
Measured: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours postdose on Days 1 and 7
Cohort 1: AUC0-t of 1-hydroxymidazolam
Cohort 1: AUC0-t of 1-hydroxymidazolam, an active metabolite of midazolam. The timepoints mentioned in the timeframe were relative to the administration of the 2-probe CYP substrate cocktail.
Measured: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours postdose on Days 1 and 7
Cohort 1: AUC0-inf of 1-hydroxymidazolam
Cohort 1: AUC0-inf of 1-hydroxymidazolam, an active metabolite of midazolam. The timepoints mentioned in the timeframe were relative to the administration of the 2-probe CYP substrate cocktail.
Measured: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours postdose on Days 1 and 7
Cohort 1: Cmax of Repaglinide
The timepoints mentioned in the timeframe were relative to the administration of the 2-probe CYP substrate cocktail.
Measured: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours postdose on Days 1 and 7
Cohort 1: AUC0-t of Repaglinide
The timepoints mentioned in the timeframe were relative to the administration of the 2-probe CYP substrate cocktail.
Measured: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours postdose on Days 1 and 7
Cohort 1: AUC0-inf of Repaglinide
The timepoints mentioned in the timeframe were relative to the administration of the 2-probe CYP substrate cocktail.
Measured: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours postdose on Days 1 and 7
Cohort 2: Cmax of Digoxin
The timepoints mentioned in the timeframe were relative to the administration of the 2-probe transporter substrate cocktail.
Measured: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96 hours postdose on Days 1 and 8
Cohort 2: AUC0-t of Digoxin
The timepoints mentioned in the timeframe were relative to the administration of the 2-probe transporter substrate cocktail.
Measured: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96 hours postdose on Days 1 and 8
Cohort 2: AUC0-inf of Digoxin
The timepoints mentioned in the timeframe were relative to the administration of the 2-probe transporter substrate cocktail.
Measured: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96 hours postdose on Days 1 and 8
Cohort 2: Cmax of Rosuvastatin
The timepoints mentioned in the timeframe were relative to the administration of the 2-probe transporter substrate cocktail.
Measured: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96 hours postdose on Days 1 and 8
Cohort 2: AUC0-t of Rosuvastatin
The timepoints mentioned in the timeframe were relative to the administration of the 2-probe transporter substrate cocktail.
Measured: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96 hours postdose on Days 1 and 8
Cohort 2: AUC0-inf of Rosuvastatin
The timepoints mentioned in the timeframe were relative to the administration of the 2-probe transporter substrate cocktail.
Measured: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96 hours postdose on Days 1 and 8

Secondary outcomes (1)

Cohorts 1 and 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
A TEAE was defined as any adverse event that began on or after the first dose of study drug or began before the first dose of study drug and worsened on or after the first dose of study drug.
Measured: Cohort 1: Day 1 up to Day 16; Cohort 2: Day 1 up to Day 22

Timeline

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

16 Oct 202328 Nov 2023

First posted23 Oct 2023
Study start16 Oct 2023
Primary completion28 Nov 2023
Study completion28 Nov 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06092931
Sponsor's protocol ID: DCE806104
Other IDs: J5B-MC-FHAE
Status last verified: Jul 2026
First submitted: 16 Oct 2023
Last updated: 19 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Single-Center, Open-Label, Fixed-Sequence Study to Evaluate the Effect of DC-806 on the Single Dose Pharmacokinetics of CYP450 Enzyme and Transporter Substrates in Healthy Participants
ClinicalTrials.gov ID: NCT06092931
Acronym / sponsor ID: DCE806104
Conditions: Healthy Participants
Keywords: DC-806, Drug-drug interaction, Midazolam, Repaglinide, Digoxin, Rosuvastatin
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 16 Oct 2023 (actual)
Primary completion: 28 Nov 2023 (actual)
Study completion: 28 Nov 2023 (actual)
First posted: 23 Oct 2023 (actual)
Results: Posted 19 Oct 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Cohort 1: DC-806 / Midazolam (CYP3A4 Substrate) + Repaglinide (CYP2C8 Substrate)	Experimental	Drug: DC-806, Drug: Midazolam, Drug: Repaglinide* Participants were administered a single oral dose of the 2-probe CYP substrate cocktail consisting of 2 milligram (mg) midazolam and 0.5 mg repaglinide under fasted conditions in the morning on Day 1. * From Days 4 through 8, participants received oral doses of 800 mg DC-806 twice daily. A single oral dose of 2-probe CYP substrate cocktail consisting of 2 mg midazolam and 0.5 mg repaglinide was co-administered under fasted conditions 1.5 hours after DC-806 dosing in the morning of Day 7.
Cohort 2: DC-806 / Digoxin (P-gp Substrate) + Rosuvastatin (BCRP/OATP1B1 Substrate)	Experimental	Drug: DC-806, Drug: Digoxin, Drug: Rosuvastatin* Participants were administered a single oral dose of the 2-probe transporter substrate cocktail consisting of 0.25 mg digoxin and 5 mg rosuvastatin under fasted conditions in the morning on Day 1. * From Days 5 through 9, participants received oral doses of 800 mg of DC-806 twice daily. A single oral dose of the 2-probe transporter substrate cocktail consisting of 0.25 mg digoxin and 5 mg rosuvastatin was co-administered under fasted conditions 1.5 hours after DC-806 dosing in the morning of Day 8.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (13 listed)

Sex: male or female; females must be of nonchildbearing potential, or postmenopausal.
Age: 18 to 55 years, inclusive, at screening.
Body mass index: 18.0 to 32.0 kg/m^2, inclusive, at screening.
Weight: ≥50 kg at screening.
Status: healthy participants.

Key exclusion criteria (16 listed)

Employee of Contract Research Organization or the Sponsor.
History of relevant drug and/or food allergies, in the opinion of the Investigator.
Females who are currently breastfeeding.
Smoking more than 5 cigarettes, 1 cigar, or 1 pipe daily within 3 months prior to screening.
Unwilling or unable to abstain from tobacco products within the 48 hours (2 days) prior to admission and during confinement in the clinical site.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DC-806Oral tablets	Drug	Cohort 1: DC-806 / Midazolam (CYP3A4 Substrate) + Repaglinide (CYP2C8 Substrate), Cohort 2: DC-806 / Digoxin (P-gp Substrate) + Rosuvastatin (BCRP/OATP1B1 Substrate)
MidazolamOral syrup	Drug	Cohort 1: DC-806 / Midazolam (CYP3A4 Substrate) + Repaglinide (CYP2C8 Substrate)
RepaglinideOral tablets	Drug	Cohort 1: DC-806 / Midazolam (CYP3A4 Substrate) + Repaglinide (CYP2C8 Substrate)
DigoxinOral tablets	Drug	Cohort 2: DC-806 / Digoxin (P-gp Substrate) + Rosuvastatin (BCRP/OATP1B1 Substrate)
RosuvastatinOral tablets	Drug	Cohort 2: DC-806 / Digoxin (P-gp Substrate) + Rosuvastatin (BCRP/OATP1B1 Substrate)

Primary outcome

Cohort 1: Maximum Observed Plasma Concentration (Cmax) of Midazolam
Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours postdose on Days 1 and 7
The timepoints mentioned in the timeframe were relative to the administration of the 2-probe CYP substrate cocktail.
Cohort 1: Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Time t, Where t is the Last Point With Concentrations Above the Lower Limit of Quantification (AUC0-t) of Midazolam
Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours postdose on Days 1 and 7
Cohort 1: AUC0-t of Midazolam. The timepoints mentioned in the timeframe were relative to the administration of the 2-probe CYP substrate cocktail.
Cohort 1: AUC From Time 0 to Infinity (AUC0-inf) of Midazolam
Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours postdose on Days 1 and 7
The timepoints mentioned in the timeframe were relative to the administration of the 2-probe CYP substrate cocktail.
Cohort 1: Cmax of 1-hydroxymidazolam
Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours postdose on Days 1 and 7
Cohort 1: Cmax of 1-hydroxymidazolam, an active metabolite of midazolam. The timepoints mentioned in the timeframe were relative to the administration of the 2-probe CYP substrate cocktail.
Cohort 1: AUC0-t of 1-hydroxymidazolam
Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours postdose on Days 1 and 7
Cohort 1: AUC0-t of 1-hydroxymidazolam, an active metabolite of midazolam. The timepoints mentioned in the timeframe were relative to the administration of the 2-probe CYP substrate cocktail.
Cohort 1: AUC0-inf of 1-hydroxymidazolam
Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours postdose on Days 1 and 7
Cohort 1: AUC0-inf of 1-hydroxymidazolam, an active metabolite of midazolam. The timepoints mentioned in the timeframe were relative to the administration of the 2-probe CYP substrate cocktail.
Cohort 1: Cmax of Repaglinide
Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours postdose on Days 1 and 7
The timepoints mentioned in the timeframe were relative to the administration of the 2-probe CYP substrate cocktail.
Cohort 1: AUC0-t of Repaglinide
Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours postdose on Days 1 and 7
The timepoints mentioned in the timeframe were relative to the administration of the 2-probe CYP substrate cocktail.
Cohort 1: AUC0-inf of Repaglinide
Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours postdose on Days 1 and 7
The timepoints mentioned in the timeframe were relative to the administration of the 2-probe CYP substrate cocktail.
Cohort 2: Cmax of Digoxin
Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96 hours postdose on Days 1 and 8
The timepoints mentioned in the timeframe were relative to the administration of the 2-probe transporter substrate cocktail.
Cohort 2: AUC0-t of Digoxin
Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96 hours postdose on Days 1 and 8
The timepoints mentioned in the timeframe were relative to the administration of the 2-probe transporter substrate cocktail.
Cohort 2: AUC0-inf of Digoxin
Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96 hours postdose on Days 1 and 8
The timepoints mentioned in the timeframe were relative to the administration of the 2-probe transporter substrate cocktail.
Cohort 2: Cmax of Rosuvastatin
Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96 hours postdose on Days 1 and 8
The timepoints mentioned in the timeframe were relative to the administration of the 2-probe transporter substrate cocktail.
Cohort 2: AUC0-t of Rosuvastatin
Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96 hours postdose on Days 1 and 8
The timepoints mentioned in the timeframe were relative to the administration of the 2-probe transporter substrate cocktail.
Cohort 2: AUC0-inf of Rosuvastatin
Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96 hours postdose on Days 1 and 8
The timepoints mentioned in the timeframe were relative to the administration of the 2-probe transporter substrate cocktail.

1 secondary outcome

Cohorts 1 and 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Cohort 1: Day 1 up to Day 16; Cohort 2: Day 1 up to Day 22

Results and safety

Results posted to the registry on 19 Oct 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1: DC-806 / Midazolam (CYP3A4 Substrate) + Repaglinide (CYP2C8 Substrate)	14	14
Cohort 2: DC-806 / Digoxin (P-gp Substrate) + Rosuvastatin (BCRP/OATP1B1 Substrate)	14	12

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

Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours postdose on Days 1 and 7. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms per milliliter (ng/mL)

Measure	Cohort 1: DC-806 / Midazolam (CYP3A4 Substrate) + Repaglinide (CYP2C8 Substrate) n = 14
Day 1	8.27 (27.9)
Day 7	24.9 (29.4)

Population analysed: All cohort 1 participants who had received at least 1 dose of study drug and had evaluable data for this outcome.

Primary outcome: Cohort 1: Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Time t, Where t is the Last Point With Concentrations Above the Lower Limit of Quantification (AUC0-t) of Midazolam

Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours postdose on Days 1 and 7. Geometric mean (Geometric Coefficient of Variation). Unit: hour*nanograms per milliliter (h*ng/mL)

Measure	Cohort 1: DC-806 / Midazolam (CYP3A4 Substrate) + Repaglinide (CYP2C8 Substrate) n = 14
Day 1	18.4 (27.4)
Day 7	82.6 (36.9)

Population analysed: All cohort 1 participants who had received at least 1 dose of study drug and had evaluable data for this outcome.

Primary outcome: Cohort 1: AUC From Time 0 to Infinity (AUC0-inf) of Midazolam

Measure	Cohort 1: DC-806 / Midazolam (CYP3A4 Substrate) + Repaglinide (CYP2C8 Substrate) n = 9
Day 1	21.4 (24.5)
Day 7	97.1 (35.8)

Population analysed: All cohort 1 participants who had received at least 1 dose of study drug and had evaluable data for this outcome.

Primary outcome: Cohort 1: Cmax of 1-hydroxymidazolam

Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours postdose on Days 1 and 7. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms per milliliter (ng/mL)

Measure	Cohort 1: DC-806 / Midazolam (CYP3A4 Substrate) + Repaglinide (CYP2C8 Substrate) n = 14
Day 1	2.94 (64.5)
Day 7	2.95 (37.9)

Population analysed: All cohort 1 participants who had received at least 1 dose of study drug and had evaluable data for this outcome.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Cohort 1: Day 1 up to Day 16; Cohort 2: Day 1 up to Day 22.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1: Midazolam + Repaglinide (Days 1 to 3)	0 of 14 (0%)	0 of 14 (0%)	0 of 14
Cohort 1: DC-806 (Days 4 to 6)	0 of 14 (0%)	2 of 14 (14.3%)	0 of 14
Cohort 1: DC-806 + Midazolam + Repaglinide (From Day 7)	0 of 14 (0%)	2 of 14 (14.3%)	0 of 14
Cohort 1: Overall [(DC-806 / Midazolam (CYP3A4 Substrate) + Repaglinide (CYP2C8 Substrate)]	0 of 14 (0%)	2 of 14 (14.3%)	0 of 14
Cohort 2: Digoxin + Rosuvastatin (Days 1 to 4)	0 of 14 (0%)	2 of 14 (14.3%)	0 of 14
Cohort 2: DC-806 (Days 5 to 7)	0 of 13 (0%)	2 of 13 (15.4%)	0 of 13
Cohort 2: DC-806 + Digoxin + Rosuvastatin (From Day 8)	0 of 13 (0%)	1 of 13 (7.7%)	0 of 13
Cohort 2: Overall [(DC-806 / Digoxin (P-gp Substrate) + Rosuvastatin (BCRP/OATP1B1 Substrate)]	0 of 14 (0%)	5 of 14 (35.7%)	0 of 14

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 19 Oct 2026. 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 United States. 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?

Yes. Results are posted in the registry (first posted 19 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Cohort 1: Maximum Observed Plasma Concentration (Cmax) of Midazolam (time frame: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours postdose on Days 1 and 7). The study lists 15 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 NCT06092931.

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 19 Oct 2026; AzTrials last refreshed its copy on 5 Nov 2026.