- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06092931
A Drug-Drug Interaction Study Evaluating the Perpetrator Potential of DC-806 on Cocktails of CYP450 Enzyme and Transporter Substrates in Healthy Participants
January 10, 2024 updated by: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: DICE Therapeutics, Inc Clinical Trial Contact
- Phone Number: Please email
- Email: clinicaltrials@dicetx.com
Study Locations
-
-
Utah
-
Salt Lake City, Utah, United States, 84124
- ICON Phase 1 Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Oral tablets
Oral syrup
Oral tablets
|
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.
|
Oral tablets
Oral tablets
Oral tablets
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cohort 1: Maximum Observed Plasma Concentration (Cmax) of Midazolam
Time Frame: Day 1 and Day 7
|
Day 1 and Day 7
|
Cohort 1: Cmax of 1-hydroxymidazolam
Time Frame: Day 1 and Day 7
|
Day 1 and Day 7
|
Cohort 1: Cmax of Repaglinide
Time Frame: Day 1 and Day 7
|
Day 1 and Day 7
|
Cohort 2: Cmax of Digoxin
Time Frame: Day 1 and Day 8
|
Day 1 and Day 8
|
Cohort 2: Cmax of Rosuvastatin
Time Frame: Day 1 and Day 8
|
Day 1 and Day 8
|
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
|
Days 1-3 and Days 7-9
|
Cohort 1: AUC0-t of 1-hydroxymidazolam
Time Frame: Days 1-3 and Days 7-9
|
Days 1-3 and Days 7-9
|
Cohort 1: AUC0-t of Repaglinide
Time Frame: Days 1-3 and Days 7-9
|
Days 1-3 and Days 7-9
|
Cohort 2: AUC0-t of Digoxin
Time Frame: Days 1-5 and Days 8-12
|
Days 1-5 and Days 8-12
|
Cohort 2: AUC0-t of Rosuvastatin
Time Frame: Days 1-5 and Days 8-12
|
Days 1-5 and Days 8-12
|
Cohort 1: AUC from Time 0 to Infinity (AUC0-inf) of Midazolam
Time Frame: Days 1-3 and Days 7-9
|
Days 1-3 and Days 7-9
|
Cohort 1: AUC0-inf of 1-hydroxymidazolam
Time Frame: Days 1-3 and Days 7-9
|
Days 1-3 and Days 7-9
|
Cohort 1: AUC0-inf of Repaglinide
Time Frame: Days 1-3 and Days 7-9
|
Days 1-3 and Days 7-9
|
Cohort 2: AUC0-inf of Digoxin
Time Frame: Days 1-5 and Days 8-12
|
Days 1-5 and Days 8-12
|
Cohort 2: AUC0-inf of Rosuvastatin
Time Frame: Days 1-5 and Days 8-12
|
Days 1-5 and Days 8-12
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cohorts 1 and 2: Number of Participant who Experience an Adverse Event
Time Frame: Up to a maximum 22 days
|
Up to a maximum 22 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 16, 2023
Primary Completion (Actual)
November 28, 2023
Study Completion (Actual)
November 28, 2023
Study Registration Dates
First Submitted
October 16, 2023
First Submitted That Met QC Criteria
October 16, 2023
First Posted (Actual)
October 23, 2023
Study Record Updates
Last Update Posted (Actual)
January 11, 2024
Last Update Submitted That Met QC Criteria
January 10, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Enzyme Inhibitors
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Antimetabolites
- Protective Agents
- Cardiotonic Agents
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Tranquilizing Agents
- Psychotropic Drugs
- Hypnotics and Sedatives
- Adjuvants, Anesthesia
- Anti-Anxiety Agents
- GABA Modulators
- GABA Agents
- Digoxin
- Midazolam
- Rosuvastatin Calcium
- Repaglinide
Other Study ID Numbers
- DCE806104
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy Participants
-
PfizerRecruitingHealthy Subjects | Healthy ParticipantsUnited States
-
Insmed IncorporatedRecruitingHealthy ParticipantsUnited States
-
Aeovian Pharmaceuticals, Inc.RecruitingHealthy ParticipantsAustralia
-
Suzhou Zelgen Biopharmaceuticals Co.,LtdRecruitingHealthy ParticipantsChina
-
CelgeneNot yet recruitingHealthy ParticipantsUnited States
-
Bristol-Myers SquibbRecruiting
-
AstraZenecaParexelRecruiting
-
ProMis Neurosciences, IncRecruiting
-
Novo Nordisk A/SRecruitingHealthy ParticipantsCanada
-
Novo Nordisk A/SRecruiting
Clinical Trials on DC-806
-
DICE Therapeutics, Inc.CompletedHealthy VolunteersNetherlands
-
DICE Therapeutics, Inc., a wholly owned subsidiary...Active, not recruitingPlaque PsoriasisCanada, Hungary, Germany, Spain, United States, Poland, United Kingdom, Czechia
-
AbbVie (prior sponsor, Abbott)CompletedAdvanced Solid TumorsUnited States, Australia
-
Aptose Biosciences Inc.Active, not recruitingNon-Hodgkin's Lymphoma | Chronic Lymphocytic Leukemia | Small Lymphocytic LymphomaUnited States
-
AbbVie (prior sponsor, Abbott)Completed
-
Aptose Biosciences Inc.Active, not recruitingAcute Myeloid Leukemia | Myelodysplastic SyndromesUnited States
-
AbbVie (prior sponsor, Abbott)Completed
-
Institut National de la Santé Et de la Recherche...Completed
-
Pusan National UniversityUnknown
-
Qingdao UniversityUnknown