A PK Study to Assess the Drug-drug Interaction of a Strong CYP2C8 Inhibitor on Adagrasib
A Phase 1, Open-label, Multiple-dose, One-sequence Crossover Study to Investigate the Effect of Repeated Oral Doses of a Strong CYP2C8 Inhibitor on the Steady-state Pharmacokinetics of Adagrasib in Healthy Adult Subjects
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Contact
Study Contact
- Name: Mirati Study Locator
- Phone Number: 844-893-5530
- Email: MiratiStudyLocator@careboxhealth.com
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75247
- Labcorp Clinical Research Unit Inc
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Males or females, of any race, between 18 and 60 years of age, inclusive, at Screening.
- Body mass index between 18.0 and 32.0 kg/m2, inclusive, at Screening.
- 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.
- 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 informed consent form (ICF) and to abide by the study restrictions.
Exclusion Criteria:
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, 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 investigational product (IP), or other substance (not including seasonal allergies).
- 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.
- Significant history or clinical manifestation of any hepatic disease.
- History or current diagnosis of uncontrolled or significant cardiac disease.
- Ventricular dysfunction or history of risk factors for Torsades de Pointes.
- History of allergic reaction to fibric acid derivatives.
- History of drug abuse within 2 years prior to Screening.
- History of alcohol abuse within 12 months prior to Screening.
- Use of tobacco- or nicotine-containing products within 3 months prior to Check-in.
- Use of any drugs or substances known or suspected to alter drug absorption, distribution, metabolism, or elimination.
- Use or intend to use any prescription medications/products within 14 days prior to Check-in.
- Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations.
- Use or intend to use slow-release medications/products considered to still be active within 14 days prior to Check-in.
- Participation in a clinical study involving administration of an investigational drug in the past 30 days or 5 half-lives prior to dosing, whichever is longer.
- Have previously completed or withdrawn from this study or any other study investigating adagrasib, and have previously received the IP.
- Receipt of blood products within 3 months prior to Check-in.
- Donation of blood from 56 days prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening.
- Subjects who, in the opinion of the Investigator, should not participate in this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pharmacokinetics - AUC (adagrasib)
Time Frame: Days 1, 8, and 18
|
Area under the plasma concentration time curve (AUC) during a dosage interval (AUCtau)
|
Days 1, 8, and 18
|
|
Pharmacokinetics - Cmax (adagrasib)
Time Frame: Days 1, 8, and 18
|
Maximum observed plasma concentration
|
Days 1, 8, and 18
|
|
Pharmacokinetics - Tmax (adagrasib)
Time Frame: Days 1, 8, and 18
|
Time to reach Cmax (tmax)
|
Days 1, 8, and 18
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adverse Events (AEs)
Time Frame: Up to 9 weeks from screening
|
Incidence and severity of AEs
|
Up to 9 weeks from screening
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- 849-024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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