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Breast CancerPhase 1NCT02621957

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

A Phase 1 study testing GDC-0810 and Pravastatin in people with Breast Cancer, run by Genentech, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Cancer
What is being tested?
GDC-0810 and Pravastatin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
Dec 2015to Feb 2016
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Study site

    Daytona Beach, Florida, 32117

Other trials in United States

About this study

Official 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

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
Being tested
GDC-0810, Pravastatin
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GDC-0810Drug

    Also called ARN-810

    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).

  • PravastatinDrug

    Also called Pravachol

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

Study groups in NCT02621957
Study groupRoleWhat they receive
Female Healthy VolunteersExperimentalHealthy 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.
Receives: Drug: GDC-0810; Drug: Pravastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Observed Concentration (Cmax) of Pravastatin

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

  2. Time to Maximum Concentration (Tmax) of Pravastatin

    Measured: 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

    Measured: 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

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

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

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

  6. Apparent Clearance (CL/F) of Pravastatin

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

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

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

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

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

  9. Amount of Pravastatin Excreted in Urine (Ae)

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

  10. Renal Clearance (CLR) of Pravastatin

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

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

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

  12. Plasma Concentrations of Pravastatin

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

Secondary outcomes (15)

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

    Measured: Days 7-10 (Period 2)

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

    Measured: 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

    Measured: Days 7-10 (Period 2)

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

    Measured: Days 7-10 (Period 2)

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

    Measured: Days 7-10 (Period 2)

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

    Measured: Days 7-10 (Period 2)

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

    Measured: Days 7-10 (Period 2)

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

    Measured: Days 7-10 (Period 2)

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

    Measured: Day 7 (Period 2)

  10. Renal Clearance (CLr) of GDC-0810

    Measured: Day 7 (Period 2)

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

    Measured: Day 7 (Period 2)

  12. Percentage of Participants with Adverse Events (AEs)

    Measured: From baseline to study completion up to Day 28

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

    Measured: 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.

    Measured: From baseline to study completion up to Day 28

  15. Plasma Concentrations of GDC-0810

    Measured: Days 7-10 (Period 2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2015 (estimated)
  2. Study startDec 2015
  3. Primary completionFeb 2016
  4. Study completionFeb 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02621957
Sponsor's protocol ID
GP29825
Status last verified
Nov 2016
First submitted
2 Dec 2015
Last updated
2 Nov 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GDC-0810 and Pravastatin in people with Breast Cancer, run by Genentech, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Observed Concentration (Cmax) of Pravastatin (time frame: Days 1-3 (Period 1) and Days 7-10 (Period 2)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02621957.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.

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