Healthy Adults
Conditions
Brief summary
A Phase 1 Study of the Effect of Acid-reducing Agents on the Pharmacokinetics of a Single Oral Dose of Sitravatinib in Healthy Adult Subjects. The study is a single-center, open-label, 2-period, 2-treatment, fixed-sequence crossover, parallel-group study.
Interventions
DRUGSitravatinib
100 mg sitravatinib on Day 1
DRUGPantoprazole
40 mg QD on Day 1 to Day 7 of Period 2 in Group 1
DRUGFamotidine
40 mg PO 2 hrs after sitravatinib in Period 2 of Group 2
Sponsors
Mirati Therapeutics Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
2 period crossover
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * Body mass index between 18.0 and 32.0 kg/m2, inclusive. * In good health, determined by no clinically significant findings from medical history, physical examination, 12 lead ECG, vital sign measurements, and clinical laboratory evaluations at screening and/or check-in, as assessed by the investigator (or qualified designee). * Females of childbearing potential will not be pregnant or lactating and must have a negative result on an approved pregnancy test at screening and check-in. Females of childbearing potential must agree to use contraception. * Male subjects must agree to use contraception. * Able to comprehend and willing to sign an ICF and to abide by the study restrictions. Key
Exclusion criteria
* Significant history of clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator. * History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, any components of the IMP, or other substance (not including seasonal allergies), unless approved by the investigator. * History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions (eg, uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study treatment or result in inability to swallow oral medications. (Uncomplicated appendectomy and hernia repair are allowed. Cholecystectomy is not allowed.) * History of Gilbert's syndrome or suspicion of Gilbert's syndrome based on elevated total and indirect bilirubin (may be confirmed by repeat). * Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to study drug administration on Day 1 of Period 1.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics - Cmax (sitravatinib) | Up to Day 7 after dosing | Maximum observed plasma concentration |
| Pharmacokinetics - AUC∞ (sitravatinib) | Up to 72 hours after dosing | Area under the plasma concentration-time curve from time zero extrapolated to infinity |
| Pharmacokinetics - AUClast (sitravatinib) | Up to 72 hours after dosing | Area under the curve from time zero to the last measured time point |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events (AEs) | Up to 9 weeks from screening | Incidence and severity of AEs |
Countries
United States
Outcome results
None listed