A Study to Explore the Effect of Acid-reducing Agents

NCT04935112 | Completed Phase 1 FDA Drug

• 1 other identifier: 516-011
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetics - Cmax (sitravatinib)

  Maximum observed plasma concentration

  Up to Day 7 after dosing

• Pharmacokinetics - AUC∞ (sitravatinib)

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

  Up to 72 hours after dosing

• Pharmacokinetics - AUClast (sitravatinib)

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

  Up to 72 hours after dosing

Secondary Outcomes (1)

• Adverse Events (AEs)

  Up to 9 weeks from screening

Study Arms (4)

Group 1 Treatment A (sitravatinib only)

EXPERIMENTAL

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

Drug: Sitravatinib

Group 1 Treatment B (sitravatinib and pantoprazole)

EXPERIMENTAL

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

Drug: Sitravatinib; Drug: Pantoprazole

Group 2 Treatment C (sitravatinib only)

EXPERIMENTAL

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

Drug: Sitravatinib

Group 2 Treatment D (sitravatinib and famotidine)

EXPERIMENTAL

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

Drug: Sitravatinib; Drug: Famotidine

Interventions

Sitravatinib DRUG

100 mg sitravatinib on Day 1

Also known as: MGCD516

Group 1 Treatment A (sitravatinib only); Group 1 Treatment B (sitravatinib and pantoprazole); Group 2 Treatment C (sitravatinib only); Group 2 Treatment D (sitravatinib and famotidine)

Pantoprazole DRUG

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

Also known as: Protonix

Group 1 Treatment B (sitravatinib and pantoprazole)

Famotidine DRUG

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

Also known as: Pepcid

Group 2 Treatment D (sitravatinib and famotidine)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mirati Therapeutics Inc.: lead

Study Sites (1)

Covance Clinical Research Unit Inc.

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Interventions

sitravatinib; Pantoprazole; Famotidine

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Thiazoles; Azoles

Study Officials

• Curtis Chin, MD

  Mirati Therapeutics Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 2 period crossover

Study Record Dates

• First Submitted: June 10, 2021
• First Posted: June 22, 2021
• Study Start: July 7, 2021
• Primary Completion: August 12, 2021
• Study Completion: July 12, 2022
• Last Updated: August 26, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)