A Study to Evaluate the Effect of Particle Size, Formulation and Food on the Pharmacokinetics of GDC-0032 in Healthy Volunteers

NCT ID: NCT01980953

Last Updated: 2017-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-07-31

Brief Summary

This 4-part study will assess the effect of formulation, food, and active pharmaceutical ingredient (API) lot on the pharmacokinetics of GDC-0032 in healthy volunteers. Part 1 is an open-label, 3-period, 6-sequence study, and Parts 2, 3, and 4 are open-label 2-period crossover studies. Participants will receive single doses of GDC-0032 capsule or tablet formulation, in the fasted or fed state.

Conditions

Healthy Volunteer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Part 1: Food Effect

GDC-0032 will be administered orally over 3-Treatment Period (TP) in 6-sequence as one 3 milligrams (mg) capsule in TP-A after 10 hour fasting from food, one 3 mg Phase III tablet in TP-B after 10 hour fasting from food and one 3 mg Phase III tablet in TP-C following the start of standard Food and Drug Administration (FDA) high-fat breakfast. Washout period o 14 to 20 days will be given between each TP.

Group Type: EXPERIMENTAL

GDC-0032 Phase III Tablet

Intervention Type: DRUG

Participants will receive 2 mg or 3 mg Phase III tablet after 10 hour fasting from food.

GDC-0032 Capsule

Intervention Type: DRUG

Participants will receive 3 mg GDC-0032 capsule formulation after 10 hour fasting from food.

Part 2: Tablet Formulation Comparison

Different formulations of tablets (Tablet A and Tablet B) of GDC-0032 will be administered orally over 2-TP having 10 hour fasting from food. Participants will receive one 3 mg Tablet A in TP-A and one 3 mg Tablet B in TP-B after 14 to 20 days washout period.

Group Type: EXPERIMENTAL

GDC-0032 Tablet

Intervention Type: DRUG

Participants will receive 3 mg Tablet A or Tablet B formulation after 10 hour fasting from food.

Part 3: Capsule API Lot Comparison

Two different lots of GDC-0032 active pharmaceutical ingredient (API) capsule formulation will be administered orally in crossover fashion over 2-TP to 20 participants having 10 hour fasting from food. Participants will receive one 3 mg capsule in TP-A and one 3 mg capsule in TP-B after 14 to 20 days washout period.

Group Type: EXPERIMENTAL

GDC-0032 Capsule

Intervention Type: DRUG

Participants will receive 3 mg GDC-0032 capsule formulation after 10 hour fasting from food.

Part 4: Tablet Relative Bioavailibity

GDC-0032 will be administered orally in crossover fashion over 2-TP to 20 participants having 10 hour fasting from food. Participants will receive one 3 mg capsule in TP-A and one 2 mg Phase III tablet in TP-B after 14 to 20 days washout period.

Group Type: EXPERIMENTAL

GDC-0032 Phase III Tablet

Intervention Type: DRUG

Participants will receive 2 mg or 3 mg Phase III tablet after 10 hour fasting from food.

GDC-0032 Capsule

Intervention Type: DRUG

Participants will receive 3 mg GDC-0032 capsule formulation after 10 hour fasting from food.

Interventions

GDC-0032 Phase III Tablet

Participants will receive 2 mg or 3 mg Phase III tablet after 10 hour fasting from food.

Intervention Type: DRUG

GDC-0032 Tablet

Participants will receive 3 mg Tablet A or Tablet B formulation after 10 hour fasting from food.

Intervention Type: DRUG

GDC-0032 Capsule

Participants will receive 3 mg GDC-0032 capsule formulation after 10 hour fasting from food.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Males or females of non-childbearing potential, between 18 and 55 years of age, inclusive; females will meet the following criteria: they will be non-pregnant, non-lactating, and either postmenopausal for at least 1 year or surgically sterile for at least 90 days.
• Body mass index (BMI) 18.5 to 32 kg/m^2, inclusive
• In good health, determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG), vital signs and clinical laboratory evaluations
• Negative test for selected drugs of abuse at Screening (does not include alcohol) and at each Check-in (Day -1; does include alcohol)
• Negative hepatitis panel (including hepatitis B surface antigen [HBsAg] and anti-hepatitis C virus [HCV]) and negative human immunodeficiency virus (HIV) antibody screens
• Males will either be sterile or agree to use approved methods of contraception as defined by protocol from Period 1 Check-in (Period 1, Day -1) until 90 days following the last dose of study drug

Exclusion Criteria

• Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder (as determined by the Investigator)
• 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 for appendectomy, hernia repair, and/or cholecystectomy
• History of alcoholism or drug addiction within 1 year prior to Period 1 Check-in (Period 1, Day -1)
• Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
• History of Type 1 or 2 diabetes mellitus and/or elevated fasting glucose (greater than [>] 120 milligrams per deciliter [mg/dL]) at baseline (as confirmed by repeat)
• History of Gilbert's Syndrome
• Evidence of malabsorption syndrome or other condition that would interfere with enteral absorption
• Inability or unwillingness to swallow pills or consume high-fat breakfast
• Use of any tobacco- or nicotine-containing products within 6 months prior to Period 1 Check-in (Period 1, Day -1) and during the entire study
• Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 5 half-lives or 30 days, whichever is longer, prior to Period 1 Check-in (Period 1, Day -1) and during the entire study duration

• 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

Covance Research Unit - Dallas

Dallas, Texas, United States

Countries

United States

Other Identifiers

GP28619

Identifier Type: -

Identifier Source: org_study_id