ONO-7018-02: Phase 1 study drug-drug interaction study with itraconazole for evaluating safety, tolerability and pharmacokinetics of ONO-7018 in healthy Japanese adult male subjects

JRCT ID: jRCT2071240038

Registered date:22/07/2024

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: TBD
• Date of first enrollment: 22/08/2024
• Target sample size: 64
• Study type: Interventional

Intervention(s)

1) Single agent administration Part
Subjects receive single oral dose of ONO-7018 or placebo.
2) Concomitant administration part
Subjects receive single oral dose of ONO-7018 with or without itraconazole.

Outcome(s)

Primary Outcome

-Adverse events that occurred after administration of ONO-7018 until the end of final examination
-Summary Statistics of Plasma ONO-7018 Concentrations and Pharmacokinetic Parameters
-Geometric mean ratios and 90% confidence intervals of Cmax and AUC of ONO-7018 in the concomitant use with itraconazole to those in the administration of ONO-7018 alone

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 45age old
• Gender: Male

Include criteria

1) Japanese healthy adult male subjects
2) Age at the time of informed consent: 18 to 45
3) BMI (at screening): 18.5 kg/m2 to less than 25.0 kg/m2

Exclude criteria

1) Subjects who are on a treatment for or with a history of respiratory, cardiovascular, psychiatric, neurologic, gastrointestinal, immunologic, hepatic, renal, hematopoietic or endocrine and/or other disease.
2) Subjects with current or with a history of severe allergy to drugs or foods
3) Subjects with current or with a history of drug or alcohol abuse

Related Information

• Primary Sponsor: Hirashima Yoshinori