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

• Status: Completed
• Trial end date: 2017-09-06
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Hydroxyitraconazole; Itraconazole

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