A Study to Explore the Effect of Acid-reducing Agents

Sponsor

Mirati Therapeutics Inc. (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04935112

Collaborator

(none)

Enrollment

Location

Arms

10.8

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Adults	Drug: Sitravatinib Drug: Pantoprazole Drug: Famotidine	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

2 period crossover2 period crossover

Masking:

None (Open Label)

Primary Purpose:

Other

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

Actual Study Start Date :

Jul 7, 2021

Actual Primary Completion Date :

Aug 12, 2021

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 Treatment A (sitravatinib only) Period 1: A single oral dose of 100 mg sitravatinib on Day 1	Drug: Sitravatinib 100 mg sitravatinib on Day 1 Other Names: MGCD516
Experimental: 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	Drug: Sitravatinib 100 mg sitravatinib on Day 1 Other Names: MGCD516 Drug: Pantoprazole 40 mg QD on Day 1 to Day 7 of Period 2 in Group 1 Other Names: Protonix
Experimental: Group 2 Treatment C (sitravatinib only) Period 1: A single oral dose of 100 mg sitravatinib on Day 1	Drug: Sitravatinib 100 mg sitravatinib on Day 1 Other Names: MGCD516
Experimental: 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	Drug: Sitravatinib 100 mg sitravatinib on Day 1 Other Names: MGCD516 Drug: Famotidine 40 mg PO 2 hrs after sitravatinib in Period 2 of Group 2 Other Names: Pepcid

Outcome Measures

Primary Outcome Measures

Pharmacokinetics - Cmax (sitravatinib) [Up to Day 7 after dosing]
Maximum observed plasma concentration
Pharmacokinetics - AUC∞ (sitravatinib) [Up to 72 hours after dosing]
Area under the plasma concentration-time curve from time zero extrapolated to infinity
Pharmacokinetics - AUClast (sitravatinib) [Up to 72 hours after dosing]
Area under the curve from time zero to the last measured time point

Secondary Outcome Measures

Adverse Events (AEs) [Up to 9 weeks from screening]
Incidence and severity of AEs

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Covance Clinical Research Unit Inc.	Madison	Wisconsin	United States	53704

Sponsors and Collaborators

Mirati Therapeutics Inc.

Investigators

Study Director: Curtis Chin, MD, Mirati Therapeutics Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mirati Therapeutics Inc.

ClinicalTrials.gov Identifier:

NCT04935112

Other Study ID Numbers:

516-011

First Posted:

Jun 22, 2021

Last Update Posted:

Dec 8, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pantoprazole

Famotidine

Study Results

No Results Posted as of Dec 8, 2021