A Study to Evaluate the Effect of a Potent Cytochrome P450 (CYP) 3A Inhibitor on Ipatasertib
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 11/11/2017 |
| Start Date: | July 18, 2017 |
| End Date: | September 6, 2017 |
Effect of a Potent CYP3A and P-gp Inhibitor (Itraconazole) on Ipatasertib Pharmacokinetics in Healthy Subjects
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).
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).
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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