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

CompletedPhase 1

Sponsor: Hoffmann-La Roche

Conditions: Healthy Volunteers

Interventions: Ipatasertib, Itraconazole

Countries: United States

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 55 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (1)

Dallas, Texas, United States