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Completed

NCT Number: NCT04935112

A Study to Explore the Effect of Acid-reducing Agents

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit Inc.

Madison, Wisconsin, 53704, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sitravatinib

Drug

100 mg sitravatinib on Day 1

Other names: MGCD516

Pantoprazole

Drug

40 mg QD on Day 1 to Day 7 of Period 2 in Group 1

Other names: Protonix

Famotidine

Drug

40 mg PO 2 hrs after sitravatinib in Period 2 of Group 2

Other names: Pepcid

Primary outcomes

  1. Pharmacokinetics - Cmax (sitravatinib)

    Time frame: Up to Day 7 after dosing

    Maximum observed plasma concentration

  2. Pharmacokinetics - AUC∞ (sitravatinib)

    Time frame: Up to 72 hours after dosing

    Area under the plasma concentration-time curve from time zero extrapolated to infinity

  3. Pharmacokinetics - AUClast (sitravatinib)

    Time frame: Up to 72 hours after dosing

    Area under the curve from time zero to the last measured time point

Secondary outcomes

  1. Adverse Events (AEs)

    Time frame: Up to 9 weeks from screening

    Incidence and severity of AEs

Sponsors and collaborators

Lead sponsor

Mirati Therapeutics Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jun 22, 2021
Registry last updated
Aug 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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