NCT05994807

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, 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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (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 primary objective of this study is 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

Interventions

Type	Name	Description
DRUG	DC-806	Oral tablets
DRUG	Itraconazole	Oral capsules
DRUG	Carbamazepine	Oral tablets

Timeline

• Start date: 2023-08-08
• Primary completion: 2023-09-20
• Completion: 2023-09-20
• First posted: 2023-08-16
• Last updated: 2023-10-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study