A Phase 1 Drug-drug Interaction Study of Ensitrelvir with Itraconazole or Carbamazepine in Healthy Adult Participants

JRCT ID: jRCT2071230049

Registered date:04/08/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: COVID-19
• Date of first enrollment: 18/08/2023
• Target sample size: 28
• Study type: Interventional
• Intervention(s): Oral administration of ensitrelvir tablet

Outcome(s)

Primary Outcome

-Ensitrelvir: Cmax, Tmax, AUC0-tau, C24
-Itraconazole: Cmax, Tmax, AUC0-tau
-Carbamazepine: Cmax, Tmax, AUC0-tau
-Adverse events, physical examination, laboratory tests, vital signs, 12-lead ECG

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 55age old
• Gender: Both
• Include criteria: Japanese healthy adult male and female participants
• Exclude criteria: Past or current medical history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data

Related Information

• Primary Sponsor: Gomez Juan Carlos