A Study to Evaluate the Effect of a Potent Cytochrome P450 (CYP) 3A Inhibitor on Ipatasertib

  • Healthy Volunteers
Trial Status:

Completed

This trial runs in
Countries
  • United States
Trial Identifier:

NCT03222310 GP30057

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

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      Trial Summary

      This study will be a single center, open-label, 2-period, fixed-sequence, Phase 1 drug-drug interaction study in healthy subjects. The primary purpose of this study is to evaluate the effect of itraconazole on the PK of ipatasertib and its primary metabolite (G-037720).

      Hoffmann-La Roche Sponsor
      Phase 1 Phase
      NCT03222310 , GP30057 Trial Identifier
      Ipatasertib, Itraconazole Treatments
      Healthy Volunteers Condition
      Official Title

      Effect of a Potent CYP3A and P-gp Inhibitor (Itraconazole) on Ipatasertib Pharmacokinetics in Healthy Subjects

      Eligibility Criteria

      All Gender
      ≥ 18 Years & ≤ 55 Years Age
      Accepts Healthy Volunteers Healthy Volunteers
      Inclusion Criteria
      • Within body mass index (BMI) range 18.5 to 32.0 kg/m2, inclusive
      • In good health, determined by no clinically significant findings from medical history, 12-lead ECG, and vital signs
      • Clinical laboratory evaluations (including chemistry panel [fasted at least 8 hours], hematology, and urinalysis [UA] with complete microscopic analysis within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator)
      • Negative test for selected drugs of abuse at Screening (does not include alcohol) and at Check-in (Day -2)
      • Negative hepatitis panel (hepatitis B surface antigen and hepatitis C virus antibody) and negative human immunodeficiency virus (HIV) antibody screens
      Exclusion Criteria
      • Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, GI, neurological, or psychiatric disorder (as determined by the Investigator)
      • History of diabetes requiring insulin or fasting glucose ≥160 mg/dL
      • History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator
      • history of stomach or intestinal surgery or resection, or other GI disorder that would potentially alter absorption and/or excretion of orally administered drugs, except that appendectomy, hernia repair, and/or cholecystectomy will be allowed
      • history or presence of an abnormal ECG, which, in the Investigator's opinion, is clinically significant

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