Healthy Adults
Conditions
Brief summary
A Phase 1, Open-label, One-sequence Crossover Study to Investigate the Effect of a Breast Cancer Resistance Protein Inhibitor on the Single-dose Pharmacokinetics of Adagrasib in Healthy Adult Subjects
Interventions
DRUGAdagrasib
Adagrasib
DRUGEltrombopag + adagrasib
Eltrombopag + adagrasib
Sponsors
Mirati Therapeutics Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
One-sequence Crossover Study
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Males or females, of any race, between 18 and 60 years of age, inclusive, at Screening. 2. Body mass index between 18.0 and 32.0 kg/m2, inclusive, at Screening. 3. In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, or clinical laboratory evaluations at Screening and Check-in as assessed by the Investigator. 4. 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. 5. Male subjects must agree to use contraception. 6. Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions.
Exclusion criteria
1. Significant history or clinical manifestation of any metabolic, allergic, dermatological, renal, hematological, thrombotic, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator. 2. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, any components of the investigational product (IP), or other substance (not including seasonal allergies). 3. History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions (eg, uncontrolled nausea, vomiting, malabsorption syndrome). 4. Significant history or clinical manifestation of any hepatic disease, as determined by laboratory abnormalities. 5. History or current diagnosis of uncontrolled or significant cardiac disease indicating significant risk of safety for participation in the study. 6. Ventricular dysfunction or history of risk factors for Torsades de Pointes. 7. History of drug abuse within 2 years prior to Screening. 8. History of alcohol abuse within 12 months prior to Screening. 9. Positive serology test results for hepatitis B surface antigen, hepatitis C antibody, and/or human immunodeficiency virus (HIV) 1/2. 10. Use of tobacco- or nicotine-containing products within 3 months prior to Check-in. 11. Use of any drugs or substances known or suspected to alter drug absorption, distribution, metabolism, or elimination. 12. Use or intend to use any prescription medications/products within 14 days prior to Check-in. 13. Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations. 14. Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days. 15. Subjects who, in the opinion of the Investigator, should not participate in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics - Tmax (adagrasib) | Days 1 and 8 | Time to reach Cmax (tmax) |
| Pharmacokinetics - AUC (adagrasib) | Days 1 and 8 | Area under the plasma concentration-time curve (AUC) from time zero to infinity (AUC∞) |
| Pharmacokinetics - Cmax (adagrasib) | Days 1 and 8 | Maximum observed plasma concentration (Cmax) |
| Pharmacokinetics - Vz/F (adagrasib) | Days 1 and 8 | Apparent volume of distribution (Vz/F) |
| Pharmacokinetics - t1/2 (adagrasib) | Days 1 and 8 | Elimination half-life (t1/2) |
| Pharmacokinetics - CL/F (adagrasib) | Days 1 and 8 | Apparent total plasma clearance (CL/F) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events (AEs) | Up to 8 weeks from screening | Incidence and severity of AEs |
Countries
United States
Outcome results
None listed