A Study to Explore the Effect of Acid-reducing Agents

NCT ID: NCT04935112

Last Updated: 2022-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-07
• Study Completion Date: 2022-07-12

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.

Conditions

Healthy Adults

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Group 1 Treatment A (sitravatinib only)

Period 1: A single oral dose of 100 mg sitravatinib on Day 1

Group Type: EXPERIMENTAL

Sitravatinib

Intervention Type: DRUG

100 mg sitravatinib on Day 1

Group 1 Treatment B (sitravatinib and pantoprazole)

Period 2: Oral pantoprazole once daily for 7 days (Days 1 to 7) and a single oral dose of 100 mg sitravatinib on Day 7

Group Type: EXPERIMENTAL

Sitravatinib

Intervention Type: DRUG

100 mg sitravatinib on Day 1

Pantoprazole

Intervention Type: DRUG

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

Group 2 Treatment C (sitravatinib only)

Period 1: A single oral dose of 100 mg sitravatinib on Day 1

Group Type: EXPERIMENTAL

Sitravatinib

Intervention Type: DRUG

100 mg sitravatinib on Day 1

Group 2 Treatment D (sitravatinib and famotidine)

Period 2: A single oral dose of 100 mg sitravatinib followed by a single oral dose of famotidine 40 mg approximately 2 hours after sitravatinib dose on Day 1

Group Type: EXPERIMENTAL

Sitravatinib

Intervention Type: DRUG

100 mg sitravatinib on Day 1

Famotidine

Intervention Type: DRUG

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

Interventions

Sitravatinib

100 mg sitravatinib on Day 1

Intervention Type: DRUG

Pantoprazole

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

Intervention Type: DRUG

Famotidine

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

Intervention Type: DRUG

Other Intervention Names

MGCD516; Protonix; Pepcid

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mirati Therapeutics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Curtis Chin, MD

Role: STUDY_DIRECTOR

Mirati Therapeutics Inc.

Locations

Covance Clinical Research Unit Inc.

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

516-011

Identifier Type: -

Identifier Source: org_study_id