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

Genentech

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Itraconazole; Drug: Cobimetinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01929876

GP28620

Details and patient eligibility

About

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 participants. Participants will receive multiple repeating doses of cobimetinib and itraconazole.

Enrollment: 16 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adult participants
• Within body mass index (BMI) range 18.5 to 32 kilogram per meter square (kg/m^2), inclusive
• Creatine phosphokinase levels below 2.5 times the upper limit of normal (ULN) and if elevated, not clinically significant
• Liver function tests for aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase below 2 times the ULN; bilirubin below 1.5 times the ULN; and all liver function test elevations not clinically significant
• In good health, determined by no clinically significant findings from medical history, 12-lead electrocardiogram (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 hepatitis B surface antigen [HBsAg] and anti-hepatitis C virus [HCV]) and negative human immunodeficiency virus (HIV) antibody screens
• Females non-pregnant or non-lactating
• Males and females (of child-bearing potential) to use two forms of adequate contraception

Exclusion criteria

• Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, 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 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

Trial design

16 participants in 1 patient group

Cobimetinib + Itraconazole

Experimental group

Treatment:

Drug: Itraconazole

Drug: Cobimetinib