Healthy VolunteersPhase 1NCT05994807
A Drug-Drug Interaction Study to Assess the Pharmacokinetics of DC-806 When Orally Administered Alone, When Coadministered With Itraconazole, and When Coadministered With Carbamazepine in Healthy Adult Participants
A Phase 1 study testing DC-806, Itraconazole and Carbamazepine in people with Healthy Volunteers, run by DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company at 1 site in United States.
Trial summary
The primary objective of this study was to assess the effect of a cytochrome P450 3A4 (CYP3A4) inhibitor (itraconazole) and CYP3A4 inducer (carbamazepine) on the single dose pharmacokinetics (PK) of DC-806 coadministered with itraconazole or carbamazepine in healthy male and female participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- DC-806, Itraconazole and Carbamazepine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2023to 20 Sep 2023
- Phase
- Phase 1
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 non-childbearing potential, or postmenopausal.
- Age : 18 to 55 years, inclusive, at screening.
- Body mass index (BMI) : 18.0 to 32.0 kg/m^2, inclusive, at screening.
- Weight : ≥50 kg, inclusive, at screening.
- Status : healthy participants. Healthy status as defined by the absence of evidence of any clinically significant, in the opinion of the investigator, active, or chronic disease.
- Male participants and female participants of childbearing potential must agree to use protocol specified methods of contraception and comply with pregnancy precautions as described in the protocol.
Show all 12Show fewer
- 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 electrocardiogram (ECG), Columbia-Suicide Severity Rating Scale (C-SSRS) (Cohort 2 only) and vital signs, as judged by the Investigator.
- Willing and able to sign the informed consent form (ICF).
Who cannot join
- Employee of ICON 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 at the clinical site.
- History of alcohol abuse or drug addiction (including soft drugs like cannabis products) within 1 year prior to screening.
Show all 23Show fewer
- 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 facility and until discharge in the study period.
- Positive screen for hepatitis B surface antigen, hepatitis C virus (HCV) antibodies, or human immunodeficiency virus (HIV) 1 and 2 antibodies.
- Consumption of any nutrients known to modulate cytochrome P450 (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 pharmacokinetics (PK) of the study drug, interfere with study compliance, or preclude informed consent.
- Cohort 2 Only:
- Individuals who have Asian ancestry (including those who have one or more Asian grandparents).
- Presence of active suicidal ideation or positive suicide behavior using the "Baseline/Screening" version of the C-SSRS and with either of the following criteria:
- History of a suicide attempt within the 5 years prior to the Screening Visit. Participants with a history of a suicide attempt more than 5 years ago should be evaluated by a mental healthcare professional (e.g., locally licensed psychiatrist, psychologist, or master's level therapist) before enrolling into the study.
- Suicidal ideation in the past month prior to the Screening Visit as indicated by a positive response ("Yes") to either Question 4 or 5 of the "Baseline/Screening" version of the C-SSRS.
- History of epilepsy.
- Leukopenia (white blood cell count <lower limit of normal [LLN]), neutropenia (neutrophil count <LLN), or thrombocytopenia (platelet count <LLN), at screening or admission (Day -1).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Single-Center, Open-Label, 2-Cohort, Fixed-Sequence, Drug-Drug Interaction Study to Assess the Pharmacokinetics of DC-806 When Orally Administered Alone, When Coadministered With Itraconazole, and When Coadministered With Carbamazepine in Healthy Adult Participants
The primary objective of this study was to assess the effect of a cytochrome P450 3A4 (CYP3A4) inhibitor (itraconazole) and CYP3A4 inducer (carbamazepine) on the single dose pharmacokinetics (PK) of DC-806 coadministered with itraconazole or carbamazepine in healthy male and female participants.
- Conditions
- Healthy Volunteers
- Being tested
- DC-806, Itraconazole, Carbamazepine
- Keywords
- DC-806, Drug-Drug Interaction, Itraconazole, Carbamazepine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DC-806Drug
Also called LY4100504
Oral tablets
ItraconazoleDrug
Oral capsules
CarbamazepineDrug
Oral tablets
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (DC-806 200 mg / Itraconazole) | Experimental | Participants received:
Period 1: A single oral dose of 200 milligram (mg) DC-806 under fasted conditions on Day 1.
Period 2: Multiple oral doses of 200 mg itraconazole once daily (QD) under fed conditions on Days 4 to 6.
Period 3:
Day 7: A single oral dose of 200 mg DC-806 was administered 2 hours after a single oral dose of 200 mg itraconazole under fasted conditions, in the morning on Day 7.
Day 8 to Day 10: QD dosing of itraconazole 200 mg was continued until Day 10 under fed conditions. Receives: Drug: DC-806; Drug: Itraconazole |
| Cohort 2 (DC-806 800 mg / Carbamazepine) | Experimental | Participants received:
Period 1: A single oral dose of 800 mg DC-806 on Day 1 under fasted conditions.
Period 2: Multiple ascending oral doses of twice daily (BID) carbamazepine, under fed conditions, as follows:
Day 4 to Day 5: BID doses of 100 mg carbamazepine. Day 6 to Day 7: BID doses of 200 mg carbamazepine. Day 8 to Day 17: BID doses of 300 mg carbamazepine.
Period 3:
Day 18, morning dosing: a single oral dose of 800 mg DC-806 was coadministered with 300 mg carbamazepine under fasted conditions.
Day 18, Evening dosing: a single oral dose of 300 mg carbamazepine were administered under fed conditions.
Day 19 to Day 20: BID administration of 300 mg carbamazepine was continued until Day 20, under fed conditions.
Day 21 to Day 22: BID doses of 200 mg carbamazepine, under fed conditions. Day 23 to Day 24: BID doses of 100 mg carbamazepine, under fed conditions. Receives: Drug: DC-806; Drug: Carbamazepine |
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 DC-806
Cmax of DC-806 alone on Day 1 and when coadministered with itraconazole on Day 7.
Measured: Day 1 (Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 18, 24, 36, 48, 72 hours postdose), Day 7 (Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96 hours postdose)
Cohort 1: Area Under the Concentration-Time Curve From Time Zero to the Last Measurable Concentration (AUC0-t) of DC-806
AUC0-t of DC-806 alone on Day 1 and when coadministered with itraconazole on Day 7.
Measured: Day 1 (Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 18, 24, 36, 48, 72 hours postdose), Day 7 (Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96 hours postdose)
Cohort 1: Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of DC-806
AUC0-inf of DC-806 alone on Day 1 and when coadministered with itraconazole on Day 7.
Measured: Day 1 (Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 18, 24, 36, 48, 72 hours postdose), Day 7 (Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96 hours postdose)
Cohort 2: Maximum Observed Plasma Concentration (Cmax) of DC-806
Cmax of DC-806 alone on Day 1 and when coadministered with carbamazepine on Day 18.
Measured: Day 1 (Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 18, 24, 36, 48, 72 hours postdose), Day 18 (Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96 hours postdose)
Cohort 2: Area Under the Concentration-Time Curve From Time Zero to the Last Measurable Concentration (AUC0-t) of DC-806
AUC0-t of DC-806 alone on Day 1 and when coadministered with carbamazepine on Day 18.
Measured: Day 1 (Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 18, 24, 36, 48, 72 hours postdose), Day 18 (Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96 hours postdose)
Cohort 2: Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of DC-806
AUC0-inf of DC-806 alone on Day 1 and when coadministered with carbamazepine on Day 18.
Measured: Day 1 (Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 18, 24, 36, 48, 72 hours postdose), Day 18 (Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96 hours postdose)
Secondary outcomes (1)
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 23; Cohort 2: Day 1 up to Day 33.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start8 Aug 2023
- Primary completion20 Sep 2023
- Study completion20 Sep 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 VolunteersStudies 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05994807
- Sponsor's protocol ID
- DCE806103
- Other IDs
- J5B-MC-FHAD
- Status last verified
- Jul 2026
- First submitted
- 9 Aug 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