Clinical trial · Interventional
Effect of GDC-0810 on the Pharmacokinetics of Pravastatin in Healthy Female Subjects of Non-Childbearing Potential
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GDC-0810 | Drug | — | UNRESOLVED |
| Pravastatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Female Healthy Volunteers
- description
- 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.
- interventionNames
- Drug: GDC-0810
- Drug: Pravastatin
Primary outcomes (12)
- measure
- Maximum Observed Concentration (Cmax) of Pravastatin
- timeFrame
- Days 1-3 (Period 1) and Days 7-10 (Period 2)
- measure
- Time to Maximum Concentration (Tmax) of Pravastatin
- timeFrame
- Days 1-3 (Period 1) and Days 7-10 (Period 2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
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