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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2071230049

Enrollment

Registered

2023-08-04

Start date

2023-08-18

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Interventions

Oral administration of ensitrelvir tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Japanese healthy adult male and female participants

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
-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	—

Contacts

Public ContactCorporate Communications Department

Shionogi & Co., Ltd.

shionogiclintrials-admin@shionogi.co.jp+81-6-6209-7885

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026