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Phase 1Completed

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

Sponsor
DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company (Industry)
Enrollment
33 enrolled
Conditions
Healthy Volunteers
Interventions
DC-806; Itraconazole; Carbamazepine
Ages
adults
Registry
NCT05994807

Full record on ClinicalTrials.gov

From the registry

The primary objective of this study was 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.

Primary outcomes

  • Cohort 1: Maximum Observed Plasma Concentration (Cmax) of DC-806
  • Cohort 1: Area Under the Concentration-Time Curve From Time Zero to the Last Measurable Concentration (AUC0-t) of DC-806
  • Cohort 1: Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of DC-806
  • Cohort 2: Maximum Observed Plasma Concentration (Cmax) of DC-806

History

  1. Results first posted

  2. Last registry update

  3. Primary completion

  4. Registered

  5. Started