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

Healthy Volunteer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01929876
• Other study ID #: GP28620
• Status: Completed
• Phase: Phase 1
• First received: August 22, 2013
• Last updated: May 4, 2016
• Start date: August 2013
• Est. completion date: September 2013

Study information

• Verified date: May 2016
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 volunteers. Volunteers will receive multiple repeating doses of cobimetinib and itraconazole. The anticipated time on study treatment is approximately one month.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• Cobimetinib
Treatment 1: single 10 mg dose of cobimetinib on day 1; Treatment 2: single 20 mg dose of cobimetinib on day 4
• itraconazole
Treatment 2: Itraconazole 200 mg once daily from Day 1 to Day 14

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma concentration versus time curve from zero to infinity ( Plasma AUCinf) of cobimetinib given alone or with Itraconazole		Approximately 1 month	No
Secondary	Safety: Incidence of adverse events		Approximately 1 month	No