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GDC-0810

Phase 1

Breast Cancer | Small molecule | Oncology |Roche Holding AG|Last Updated: Nov 2, 2016

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment15

FDA Designations

No designations recorded

Clinical trial landscape

GDC-0810 · 2 trials · 2 indications

Phase 1 2
NCT02802670A Pharmacokinetic Study of [14C]-GDC-0810 After Single Oral Administration in Healthy Female ParticipantsHealthy Volunteers
COMPLETED7 Analytics
NCT02621957Effect of GDC-0810 on the Pharmacokinetics of Pravastatin in Healthy Female Subjects of Non-Childbearing PotentialBreast Cancer
COMPLETED15 Analytics
PHASE1COMPLETED
A Pharmacokinetic Study of [14C]-GDC-0810 After Single Oral Administration in Healthy Female Participants
Healthy Volunteers
NCT028026707
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PHASE1COMPLETED
Effect of GDC-0810 on the Pharmacokinetics of Pravastatin in Healthy Female Subjects of Non-Childbearing Potential
Breast Cancer
NCT0262195715
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Study Endpoints

Primary Endpoints

Cmax for [14C]-GDC-0810
Pre-dose (0 hr), 10, 30, 45 mins, 1, 2, 3, 4, 6, 8, 12 hrs post-dose on Day 1, Day 2 (24, 36 hrs post-dose), Days 3, 4, 5, 6, and 7 post-dose
Time to maximum concentration (Tmax) for GDC-0810
Pre-dose (0 hr), 10, 30, 45 mins, 1, 2, 3, 4, 6, 8, 12 hrs post-dose on Day 1, Day 2 (24, 36 hrs post-dose), Days 3, 4, 5, 6, and 7 post-dose
Tmax for [14C]-GDC-0810
Pre-dose (0 hr), 10, 30, 45 mins, 1, 2, 3, 4, 6, 8, 12 hrs post-dose on Day 1, Day 2 (24, 36 hrs post-dose), Days 3, 4, 5, 6, and 7 post-dose
Area under the Concentration-Time Curve (AUC) from Hour 0 to Last Measurable Concentration (AUC0-t) for GDC-0810
Pre-dose (0 hr), 10, 30, 45 mins, 1, 2, 3, 4, 6, 8, 12 hrs post-dose on Day 1, Day 2 (24, 36 hrs post-dose), Days 3, 4, 5, 6, and 7 post-dose
AUC0-t for [14C]-GDC-0810
Pre-dose (0 hr), 10, 30, 45 mins, 1, 2, 3, 4, 6, 8, 12 hrs post-dose on Day 1, Day 2 (24, 36 hrs post-dose), Days 3, 4, 5, 6, and 7 post-dose
AUC Extrapolated to Infinity (AUC0-inf) for GDC-0810
Pre-dose (0 hr), 10, 30, 45 mins, 1, 2, 3, 4, 6, 8, 12 hrs post-dose on Day 1, Day 2 (24, 36 hrs post-dose), Days 3, 4, 5, 6, and 7 post-dose
AUC0-inf for [14C]-GDC-0810
Pre-dose (0 hr), 10, 30, 45 mins, 1, 2, 3, 4, 6, 8, 12 hrs post-dose on Day 1, Day 2 (24, 36 hrs post-dose), Days 3, 4, 5, 6, and 7 post-dose
Apparent Terminal Rate Elimination Constant for GDC-0810
Pre-dose (0 hr), 10, 30, 45 mins, 1, 2, 3, 4, 6, 8, 12 hours post-dose on Day 1, Day 2 (24, 36 hours post-dose), Days 3, 4, 5, 6, and 7 post-dose
Maximum Observed Concentration (Cmax) for GDC-0810
Pre-dose [0 hour (hr)], 10, 30, 45 minutes (min), 1, 2, 3, 4, 6, 8, 12 hrs post-dose on Day 1, Day 2 (24, 36 hrs post-dose), Days 3, 4, 5, 6, and 7 post-dose
Apparent Terminal Elimination Constant for [14C]-GDC-0810
Pre-dose (0 hr), 10, 30, 45 mins, 1, 2, 3, 4, 6, 8, 12 hours post-dose on Day 1, Day 2 (24, 36 hours post-dose), Days 3, 4, 5, 6, and 7 post-dose
Apparent Terminal Elimination Half-Life (t1/2) for GDC-0810
Pre-dose (0 hr), 10, 30, 45 mins, 1, 2, 3, 4, 6, 8, 12 hrs post-dose on Day 1, Day 2 (24, 36 hrs post-dose), Days 3, 4, 5, 6, and 7 post-dose
t1/2 for [14C]-GDC-0810
Pre-dose (0 hr), 10, 30, 45 mins, 1, 2, 3, 4, 6, 8, 12 hrs post-dose on Day 1, Day 2 (24, 36 hrs post-dose), Days 3, 4, 5, 6, and 7 post-dose
Apparent Oral Clearance (CL/F) for GDC-0810
Pre-dose (0 hr), 10, 30, 45 mins, 1, 2, 3, 4, 6, 8, 12 hrs post-dose on Day 1, Day 2 (24, 36 hrs post-dose), Days 3, 4, 5, 6, and 7 post-dose
Apparent Volume of Distribution (Vz/F) for GDC-0810
Pre-dose (0 hr), 10, 30, 45 mins, 1, 2, 3, 4, 6, 8, 12 hrs post-dose on Day 1, Day 2 (24, 36 hrs post-dose), Days 3, 4, 5, 6, and 7 post-dose
Amount of Total Radioactivity Excreted in Urine Over the Sampling Interval (Aeu) for [14C]-GDC-0810 (Whenever Possible)
Pre-dose (0 hr), 0 to 12 and 12 to 24 hrs post-dose on Day 1, Days 2 (24 to 48 hrs), 3 (48 to 72 hrs), 4 (72 to 96 hrs), 5 (96 to 120 hrs), 6 (120 to 144 hrs) post-dose, and at 24-hr interval from Days 7-14 or until clinical discharge criteria met
Cumulative Aeu (Total Aeu) of [14C]-GDC-0810 (Whenever Possible)
Pre-dose (0 hr), 0 to 12 and 12 to 24 hrs post-dose on Day 1, Days 2 (24 to 48 hrs), 3 (48 to 72 hrs), 4 (72 to 96 hrs), 5 (96 to 120 hrs), 6 (120 to 144 hrs) post-dose, and at 24-hr interval from Days 7-14 or until clinical discharge criteria met
Renal Clearance (CLR) for [14C]-GDC-0810 (Whenever Possible)
Pre-dose (0 hr), 0 to 12 and 12 to 24 hrs post-dose on Day 1, Days 2 (24 to 48 hrs), 3 (48 to 72 hrs), 4 (72 to 96 hrs), 5 (96 to 120 hrs), 6 (120 to 144 hrs) post-dose, and at 24-hr interval from Days 7-14 or until clinical discharge criteria met
Percent of Total radioactivity Excreted in Urine Over Sampling (% Feu) for [14C]-GDC-0810 (Whenever Possible)
Pre-dose (0 hr), 0 to 12 and 12 to 24 hrs post-dose on Day 1, Days 2 (24 to 48 hrs), 3 (48 to 72 hrs), 4 (72 to 96 hrs), 5 (96 to 120 hrs), 6 (120 to 144 hrs) post-dose, and at 24-hr interval from Days 7-14 or until clinical discharge criteria met
Cumulative % Feu (Total % Feu) for [14C]-GDC-0810 (Whenever Possible)
Pre-dose (0 hr), 0 to 12 and 12 to 24 hrs post-dose on Day 1, Days 2 (24 to 48 hrs), 3 (48 to 72 hrs), 4 (72 to 96 hrs), 5 (96 to 120 hrs), 6 (120 to 144 hrs) post-dose, and at 24-hr interval from Days 7-14 or until clinical discharge criteria met
Amount of Total Radioactivity Excreted in Feces Over the Sampling Interval (Aef) for [14C]-GDC-0810 (Whenever Possible)
Pre-dose (0 hr), 0 to 24 hrs post-dose on Day 1, Days 2 (24 to 48 hrs), 3 (48 to 72 hrs), 4 (72 to 96 hrs), 5 (96 to 120 hrs), 6 (120 to 144 hrs) post-dose, and at 24-hr interval from Days 7-14 post-dose or until clinical discharge criteria met
Cumulative Aef (Total Aef) for [14C]-GDC-0810 (Whenever Possible)
Pre-dose (0 hr), 0 to 24 hrs post-dose on Day 1, Days 2 (24 to 48 hrs), 3 (48 to 72 hrs), 4 (72 to 96 hrs), 5 (96 to 120 hrs), 6 (120 to 144 hrs) post-dose, and at 24-hr interval from Days 7-14 post-dose or until clinical discharge criteria met
Percent of Total radioactivity Excreted in Feces Over Sampling (% Fef) for [14C]-GDC-0810 (Whenever Possible)
Pre-dose (0 hr), 0 to 24 hrs post-dose on Day 1, Days 2 (24 to 48 hrs), 3 (48 to 72 hrs), 4 (72 to 96 hrs), 5 (96 to 120 hrs), 6 (120 to 144 hrs) post-dose, and at 24-hr interval from Days 7-14 post-dose or until clinical discharge criteria met
Cumulative % Fef (Total % Fef) for [14C]-GDC-0810 (Whenever Possible)
Pre-dose (0 hr), 0 to 24 hrs post-dose on Day 1, Days 2 (24 to 48 hrs), 3 (48 to 72 hrs), 4 (72 to 96 hrs), 5 (96 to 120 hrs), 6 (120 to 144 hrs) post-dose, and at 24-hr interval from Days 7-14 post-dose or until clinical discharge criteria met
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 Endpoints

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)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
GDC-0810EXPERIMENTALGDC-0810 300-mg dose administered as oral solution, containing approximately 100 microcuries of \[14C\]-labeled GDC-0810.
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.

Interventions

NameTypeDescription
[14C]-GDC-0810DRUGParticipants will receive a single 300-mg dose of GDC-0810 containing approximately 100 microcuries of \[14C\]-labeled GDC-0810 on Day 1.
GDC-0810DRUGDuring 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).
PravastatinDRUGSubjects will receive a single oral dose of 10 mg pravastatin on Day 1 in Period 1 and Day 7 in Period 2.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy participants with non-child bearing potential, non-pregnant, non-lactating and either post-menopausal or surgically sterile. * Negative pregnancy test result at Screening and at Day -1. * Body mass index of 18.5 to 29.9 kilogram per square meter. * Healthy condition do...

Countries:United States
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Competitive Landscape -Breast Cancer 402 trials

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Puma Biotechnology, Inc.PBYI3PHASE2Neratinib, Loperamide, Colesevelam
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Frequently asked questions about GDC-0810

What is GDC-0810 used for?

GDC-0810 is an investigational small molecule being studied for use in breast cancer and in healthy volunteers. It is being developed by Roche Holding AG (ticker: RHHBY) and is currently in Phase 1 clinical development. The drug has been evaluated in clinical trials involving healthy female subjects.

Who makes GDC-0810?

GDC-0810 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The drug is a small molecule in Phase 1 clinical development for oncology, specifically for breast cancer. Roche has conducted clinical trials of GDC-0810 in the United States.

What phase is GDC-0810 in?

GDC-0810 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials have been completed, including studies in healthy volunteers and in patients with breast cancer, but the drug remains in early-stage development.

What clinical trials is GDC-0810 in?

GDC-0810 has been studied in two completed Phase 1 clinical trials. NCT02621957 evaluated the effect of GDC-0810 on the pharmacokinetics of pravastatin in healthy female subjects, and NCT02802670 was a pharmacokinetic study of [14C]-GDC-0810 after single oral administration in healthy female participants. Both trials were conducted in the United States.

Is GDC-0810 the same as any other drug?

No alternative names for GDC-0810 have been disclosed. The drug is identified by its code name GDC-0810 in clinical trials and is being developed by Roche. It is a small molecule investigational agent studied in Phase 1 trials for breast cancer and healthy volunteer studies.