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Completed

NCT Number: NCT02621957

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Daytona Beach, Florida, 32117, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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).

Other names: ARN-810

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.

Other names: Pravachol

Primary outcomes

  1. Maximum Observed Concentration (Cmax) of Pravastatin

    Time frame: Days 1-3 (Period 1) and Days 7-10 (Period 2)

  2. Time to Maximum Concentration (Tmax) of Pravastatin

    Time frame: Days 1-3 (Period 1) and Days 7-10 (Period 2)

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

    Time frame: Days 1-3 (Period 1) and Days 7-10 (Period 2)

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

    Time frame: Days 1-3 (Period 1) and Days 7-10 (Period 2)

  5. Apparent Volume of Distribution (Vz/F) of Pravastatin

    Time frame: Days 1-3 (Period 1) and Days 7-10 (Period 2)

  6. Apparent Clearance (CL/F) of Pravastatin

    Time frame: Days 1-3 (Period 1) and Days 7-10 (Period 2)

  7. Apparent Terminal Elimination Rate Constant (lambda z) of Pravastatin

    Time frame: Days 1-3 (Period 1) and Days 7-10 (Period 2)

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

    Time frame: Days 1-3 (Period 1) and Days 7-10 (Period 2)

  9. Amount of Pravastatin Excreted in Urine (Ae)

    Time frame: Day 1 (Period 1) and Day 7 (Period 2)

  10. Renal Clearance (CLR) of Pravastatin

    Time frame: Day 1 (Period 1) and Day 7 (Period 2)

  11. Percentage of Pravastatin Excreted in Urine (%Excreted)

    Time frame: Day 1 (Period 1) and Day 7 (Period 2)

  12. Plasma Concentrations of Pravastatin

    Time frame: Days 1-3 (Period 1) and Days 7-10 (Period 2)

Secondary outcomes

  1. Maximum Observed Concentration (Cmax) of GDC-0810

    Time frame: Days 7-10 (Period 2)

  2. Time to Maximum Concentration (Tmax) of GDC-0810

    Time frame: Days 7-10 (Period 2)

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

    Time frame: Days 7-10 (Period 2)

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

    Time frame: Days 7-10 (Period 2)

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

    Time frame: Days 7-10 (Period 2)

  6. Apparent Clearance (CL/F) of GDC-0810

    Time frame: Days 7-10 (Period 2)

  7. Apparent Terminal Elimination Rate Constant (lambda z) of GDC-0810

    Time frame: Days 7-10 (Period 2)

  8. Apparent Terminal Elimination Half-Life (t1/2) of GDC-0810

    Time frame: Days 7-10 (Period 2)

  9. Amount of GDC-0810 Excreted in Urine (Ae)

    Time frame: Day 7 (Period 2)

  10. Renal Clearance (CLr) of GDC-0810

    Time frame: Day 7 (Period 2)

  11. Percentage of GDC-0810 Excreted in Urine (%Excreted)

    Time frame: Day 7 (Period 2)

  12. Percentage of Participants with Adverse Events (AEs)

    Time frame: From baseline to study completion up to Day 28

  13. Percentage of Participants with Serious Adverse Events (SAEs)

    Time frame: From baseline to study completion up to Day 28

  14. Percentage of Participants with Clinically Significant Changes in Safety Measurements, Including Vital Signs, Electrocardiograms (ECGs), Physical Examination Findings and Clinical Laboratory Results.

    Time frame: From baseline to study completion up to Day 28

  15. Plasma Concentrations of GDC-0810

    Time frame: Days 7-10 (Period 2)

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

A Phase 1, Open-Label Study to Evaluate the Effect of GDC-0810 on the Pharmacokinetics of Pravastatin in Healthy Female Subjects of Non-Childbearing Potential

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 4, 2015
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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