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

NCT ID: NCT01929876

Last Updated: 2016-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2013-10-31

Brief Summary

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.

Conditions

Healthy Participants

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Cobimetinib + Itraconazole

Group Type: EXPERIMENTAL

Cobimetinib

Intervention Type: DRUG

10 milligram (mg) (2\* 5 mg capsules) will be administered orally on Day 1 of Period 1 and Day 4 of Period 2

Itraconazole

Intervention Type: DRUG

200 mg oral solution will be administered once daily from Day 1 to Day 14 of Period 2

Interventions

Cobimetinib

10 milligram (mg) (2\* 5 mg capsules) will be administered orally on Day 1 of Period 1 and Day 4 of Period 2

Intervention Type: DRUG

Itraconazole

200 mg oral solution will be administered once daily from Day 1 to Day 14 of Period 2

Intervention Type: DRUG

Other Intervention Names

GDC-0973

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Genentech, Inc.

Locations

Dallas, Texas, United States

Countries

United States

Other Identifiers

GP28620

Identifier Type: -

Identifier Source: org_study_id