A Drug-Drug Interaction Study Evaluating the Perpetrator Potential of DC-806 on Cocktails of CYP450 Enzyme and Transporter Substrates in Healthy Participants
NCT06092931 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28
Last updated 2024-01-11
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
- DRUG
-
DC-806
Oral tablets
- DRUG
-
Midazolam
Oral syrup
- DRUG
-
Repaglinide
Oral tablets
- DRUG
-
Digoxin
Oral tablets
- DRUG
-
Rosuvastatin
Oral tablets
Sponsors & Collaborators
-
DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-10-16
- Primary Completion
- 2023-11-28
- Completion
- 2023-11-28
- FDA Drug
- Yes
Countries
- United States
Study Locations
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