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
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.
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.
Exclusion Criteria:
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
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
Oral tablets
Oral syrup
Oral tablets
Oral tablets
Oral tablets
Cohort 1: Maximum Observed Plasma Concentration (Cmax) of Midazolam
Time frame: Day 1 and Day 7
Cohort 1: Cmax of 1-hydroxymidazolam
Time frame: Day 1 and Day 7
Cohort 1: Cmax of Repaglinide
Time frame: Day 1 and Day 7
Cohort 2: Cmax of Digoxin
Time frame: Day 1 and Day 8
Cohort 2: Cmax of Rosuvastatin
Time frame: 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
Cohort 1: AUC0-t of 1-hydroxymidazolam
Time frame: Days 1-3 and Days 7-9
Cohort 1: AUC0-t of Repaglinide
Time frame: Days 1-3 and Days 7-9
Cohort 2: AUC0-t of Digoxin
Time frame: Days 1-5 and Days 8-12
Cohort 2: AUC0-t of Rosuvastatin
Time frame: 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
Cohort 1: AUC0-inf of 1-hydroxymidazolam
Time frame: Days 1-3 and Days 7-9
Cohort 1: AUC0-inf of Repaglinide
Time frame: Days 1-3 and Days 7-9
Cohort 2: AUC0-inf of Digoxin
Time frame: Days 1-5 and Days 8-12
Cohort 2: AUC0-inf of Rosuvastatin
Time frame: Days 1-5 and Days 8-12
Cohorts 1 and 2: Number of Participant who Experience an Adverse Event
Time frame: Up to a maximum 22 days
Plan to share: No
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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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DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company