About this trial
The primary objective of this trial is to assess the effect of a known P-gp inhibitor, itraconazole, on the PK of engasertib in healthy adult participants.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age of 18 to 55 years (both inclusive), at the time of signing the informed consent.
Body weight ≥ 50 and < 120 kg and a body mass index (BMI) within the range 18 to 30 kg/m² (both inclusive) at screening.
Male and female participants are eligible to participate if they are not fertile or if they agree to either be abstinent from intercourse where pregnancy can occur or use contraception/barrier as detailed in the protocol.
Overtly healthy as determined by medical evaluation including medical history, physical examination, vital signs, electrocardiogram (ECG).
Disqualifiers
Any history or evidence of any clinically relevant cardiovascular, hepatic, renal, gastrointestinal, pancreatic, endocrinologic, hematologic, immunologic, metabolic, and/or other major disease or malignancy as determined by medical evaluation (including physical examination) 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.
Any clinically important illness, medical/surgical procedure, or condition, which, in the opinion of the investigator, is likely to interfere with the study conduct.
Known or suspected hypersensitivity to engasertib, or itraconazole, or any components of the formulation used.
History of significant or uncontrolled skin disorders, per the Investigator's judgement.
Trial design
Sequential
Treatments tested in this trial
Engasertib
DrugParticipants will take engasertib orally as capsules.
Itraconazole
DrugParticipants will take itraconazole as 20 mL of 10 mg/mL oral solution.
Treatment groups
Trial outcomes
Primary outcomes
Area Under the Concentration-time Curve (AUC) from Zero to the Last Quantifiable Concentration (AUC0-tlast) of Engasertib
AUC from Zero to Infinity (AUC0-inf) of Engasertib
Maximum Plasma Concentration (Cmax) of Engasertib
Locations
Sponsors and contacts
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