NCT06092931

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, 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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	DC-806	Oral tablets
DRUG	Midazolam	Oral syrup
DRUG	Repaglinide	Oral tablets
DRUG	Digoxin	Oral tablets
DRUG	Rosuvastatin	Oral tablets

Timeline

• Start date: 2023-10-16
• Primary completion: 2023-11-28
• Completion: 2023-11-28
• First posted: 2023-10-23
• Last updated: 2024-01-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study