A Study to Explore the Effect of Acid-reducing Agents

Healthy Adults Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04935112
• Other study ID #: 516-011
• Status: Completed
• Phase: Phase 1
• Start date: July 7, 2021
• Est. completion date: July 12, 2022

Study information

• Verified date: August 2022
• Source: Mirati Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 12, 2022
• Est. primary completion date: August 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Adults

Intervention

Drug:
• Sitravatinib
100 mg sitravatinib on Day 1
• Pantoprazole
40 mg QD on Day 1 to Day 7 of Period 2 in Group 1
• Famotidine
40 mg PO 2 hrs after sitravatinib in Period 2 of Group 2

Locations

Country	Name	City	State
United States	Covance Clinical Research Unit Inc.	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Mirati Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics - Cmax (sitravatinib)	Maximum observed plasma concentration	Up to Day 7 after dosing
Primary	Pharmacokinetics - AUC8 (sitravatinib)	Area under the plasma concentration-time curve from time zero extrapolated to infinity	Up to 72 hours after dosing
Primary	Pharmacokinetics - AUClast (sitravatinib)	Area under the curve from time zero to the last measured time point	Up to 72 hours after dosing
Secondary	Adverse Events (AEs)	Incidence and severity of AEs	Up to 9 weeks from screening