Effect of GDC-0810 on the Pharmacokinetics of Pravastatin in Healthy Female Subjects of Non-Childbearing Potential

NCT02621957 | Completed Phase 1

• 1 other identifier: GP29825
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to assess the pharmacokinetics (PK) of a single dose of pravastatin with and without concomitant GDC-0810 administration in healthy female subjects of non-childbearing potential. During Period 1 (Day -1 to Day 4) PK parameters of pravastatin will be determined in the absence of GDC-0810. During Period 2 (Days 5-28) PK parameters of pravastatin will be determined in the presence of GDC-0810.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (12)

• Maximum Observed Concentration (Cmax) of Pravastatin

  Days 1-3 (Period 1) and Days 7-10 (Period 2)

• Time to Maximum Concentration (Tmax) of Pravastatin

  Days 1-3 (Period 1) and Days 7-10 (Period 2)

• Area Under the Concentration-Time Curve from Hour 0 to the Last Measurable Concentration (AUC0-t) of Pravastatin

  Days 1-3 (Period 1) and Days 7-10 (Period 2)

• Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of Pravastatin

  Days 1-3 (Period 1) and Days 7-10 (Period 2)

• Apparent Volume of Distribution (Vz/F) of Pravastatin

  Days 1-3 (Period 1) and Days 7-10 (Period 2)

• Apparent Clearance (CL/F) of Pravastatin

  Days 1-3 (Period 1) and Days 7-10 (Period 2)

• Apparent Terminal Elimination Rate Constant (lambda z) of Pravastatin

  Days 1-3 (Period 1) and Days 7-10 (Period 2)

• Apparent Terminal Elimination Half-Life (t1/2) of Pravastatin

  Days 1-3 (Period 1) and Days 7-10 (Period 2)

• Amount of Pravastatin Excreted in Urine (Ae)

  Day 1 (Period 1) and Day 7 (Period 2)

• Renal Clearance (CLR) of Pravastatin

  Day 1 (Period 1) and Day 7 (Period 2)

• Percentage of Pravastatin Excreted in Urine (%Excreted)

  Day 1 (Period 1) and Day 7 (Period 2)

• Plasma Concentrations of Pravastatin

  Days 1-3 (Period 1) and Days 7-10 (Period 2)

Secondary Outcomes (15)

• Maximum Observed Concentration (Cmax) of GDC-0810

  Days 7-10 (Period 2)

• Time to Maximum Concentration (Tmax) of GDC-0810

  Days 7-10 (Period 2)

• Area Under the Concentration-Time Curve from Hour 0 to the Last Measurable Concentration (AUC0-t) of GDC-0810

  Days 7-10 (Period 2)

• Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of GDC-0810

  Days 7-10 (Period 2)

• Apparent Volume of Distribution (Vz/F) of GDC-0810

  Days 7-10 (Period 2)

Study Arms (1)

Female Healthy Volunteers

EXPERIMENTAL

Healthy volunteer female subjects of non-childbearing potential will be administered pravastatin once on Day 1 during Period 1 (Day -1 to Day 4). During Period 2 (Days 5-28) GDC-0810 will be administered daily on Days 5-8. Pravastatin will be co-administered on Day 7.

Drug: GDC-0810; Drug: Pravastatin

Interventions

GDC-0810 DRUG

During Period 2 subjects will be administered an oral 600 mg dose GDC-0810 daily beginning on Day 5 for 4 consecutive days (from Days 5 to 8, inclusive).

Also known as: ARN-810

Female Healthy Volunteers

Pravastatin DRUG

Subjects will receive a single oral dose of 10 mg pravastatin on Day 1 in Period 1 and Day 7 in Period 2.

Also known as: Pravachol

Female Healthy Volunteers

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female subjects between 18 and 65 years of age, inclusive.
• Female subjects of non-childbearing potential including non-pregnant, non-lactating, and either postmenopausal or surgically sterile for at least 45 days post procedure.
• Within BMI range 18.5 to \</= 29.9 kg/m\^2, inclusive.
• In good health, as determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), vital signs, and clinical laboratory evaluations.
• Receive an explanation of the mandatory pharmacogenomic (PgX) component of the study.

You may not qualify if:

• Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder.
• Previous history of adverse reaction to statins.
• Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 30 days or 5 half-lives, whichever is longer, prior to Check-in (Day -1) in Period 1.
• Use of systemic hormone replacement therapy within 1 year prior to Check-in (Day -1).
• History of use of tamoxifen, aromatase inhibitor or any other endocrine agent for treatment of breast cancer.
• Female subject is pregnant lactating, or breast feeding.

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (1)

Unknown Facility

Daytona Beach, Florida, 32117, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

3-(4-(2-(2-chloro-4-fluorophenyl)-1-(1H-indazol-5-yl)but-1-en-1-yl)phenyl)acrylic acid; Pravastatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2015
• First Posted: December 4, 2015
• Study Start: December 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

US (1)