A Study to Evaluate of Itraconazole on the Pharmacokinetics of Cobimetinib in Healthy Volunteers



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 55
Updated:5/6/2016
Start Date:August 2013
End Date:September 2013

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A Phase 1, Open-Label Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of Cobimetinib in Healthy Subjects

This open-label, 2-period, fixed sequence, drug interaction study will investigate the
effect of co-administration of itraconazole on the pharmacokinetics of cobimetinib in
healthy volunteers. Volunteers will receive multiple repeating doses of cobimetinib and
itraconazole. The anticipated time on study treatment is approximately one month.


Inclusion Criteria:

- Healthy adult volunteers

- Within BMI range 18.5 to 32 kg/m2, inclusive

- Creatine phosphokinase levels must be below 2.5 times the upper limit of normal (ULN)
and if elevated, must not be clinically significant

- Liver function tests for aspartate aminotransferase, alanine aminotransferase, and
alkaline phosphatase must be below 2 times the ULN; bilirubin must be below 1.5 times
the ULN; and all liver function test elevations must not be clinically significant

- In good health, determined by no clinically significant findings from medical
history, 12-lead ECG, and vital signs

- Clinical laboratory evaluations 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 and at each Check-in

- Negative hepatitis panel (including HBsAg and anti-HCV) and negative HIV antibody
screens

- Females must not be pregnant or lactating

- Males and females (of child-bearing potential) must use two forms of adequate
contraception

Exclusion Criteria:

- Significant history or clinical manifestation of any metabolic, allergic,
dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, GI,
neurological, or psychiatric disorder

- 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 that would potentially alter
absorption and/or excretion of orally administered drugs; except that appendectomy,
hernia repair, and/or cholecystectomy will be allowed

- History of diabetes mellitus and/or elevated fasting glucose at baseline

- History or presence of an abnormal ECG, which, in the Investigator's opinion, is
clinically significant

- History of alcoholism or drug addiction within 1 year prior to study start

- Use of any tobacco- or nicotine-containing products (within 6 months prior to study
start and during the entire study

- Participation in any other investigational study drug or biologic agent trial in
which receipt of an investigational study drug occurred within 5 half-lives or 30
days, whichever is longer, or exposure to any biological therapy or investigational
biological agent within 90 days prior to study entry and during the entire study from
study start to Study Completion, inclusive
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