Effect of a Known P-glycoprotein (P-gp) Inhibitor, Itraconazole, on the Pharmacokinetics (PK) of Engasertib

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorVaderis Therapeutics AG

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 volunteers

Qualifiers

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

Design model

Sequential

Treatments tested in this trial

  • Engasertib

    Drug

    Participants will take engasertib orally as capsules.

  • Itraconazole

    Drug

    Participants will take itraconazole as 20 mL of 10 mg/mL oral solution.

Treatment groups

27 Participants
are divided into 1 treatment group
Group A: Engasertib 40 mg + Itraconazole 200 mgExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Area Under the Concentration-time Curve (AUC) from Zero to the Last Quantifiable Concentration (AUC0-tlast) of Engasertib

Time frame
Day 1 up to Day 26
2

AUC from Zero to Infinity (AUC0-inf) of Engasertib

Time frame
Day 1 up to Day 26
3

Maximum Plasma Concentration (Cmax) of Engasertib

Time frame
Day 1 up to Day 26

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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