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Tyrosine Kinase Inhibitor

Group 1 Treatment B for Healthy Adults

Phase 1

Waitlist Available

Research Sponsored by Mirati Therapeutics Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 168 hours after dosing

Awards & highlights

Study Summary

This trial looks at the effect of two drugs, itraconazole and rifampin, on the safety and how well sitravatinib works in healthy people.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 168 hours after dosing

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 168 hours after dosing

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 168 hours after dosing for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pharmacokinetics - AUClast (sitravatinib)

Pharmacokinetics - AUC∞ (sitravatinib)

Pharmacokinetics - CL/F (sitravatinib)

+4 more

Secondary outcome measures

Adverse Events (AEs)

Trial Design

4Treatment groups

Active Control

Group I: Group 1 Treatment BActive Control1 Intervention

On Days 9 to 11, itraconazole 200 mg will be administered QD in the morning. On Day 12, a single dose of sitravatinib malate 50 mg will be coadministered with itraconazole. Itraconazole QD dosing will continue on Days 13 to 18 to maintain steady state during the PK sample collection period.

Group II: Group 2 Treatment AActive Control1 Intervention

A single-dose administration of sitravatinib malate 100 mg on Day 1 will be followed by a 72-hour PK sample collection period. Subjects will be discharged from the CRU on Day 4 after collection of 72-hour postdose PK sample and completion of all required study procedures.

Group III: Group 1 Treatment AActive Control1 Intervention

A single-dose administration of sitravatinib malate 50 mg on Day 1. Day 12, a single dose of sitravatinib malate 50 mg will be will be followed by a 72-hour PK sample collection period. Subjects will be discharged from the CRU on Day 4 after collection of 72-hour postdose PK sample and completion of all required study procedures.

Group IV: Group 2 Treatment BActive Control1 Intervention

On Days 9 to 15, rifampin 600 mg will be administered QD in the morning. On Day 16, a single dose of sitravatinib malate 100 mg will be coadministered with rifampin followed by a 72 hour PK sample collection period. Rifampin QD dosing will continue on Days 17 to 22 to maintain steady state during the PK sample collection period.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Mirati Therapeutics Inc.Lead Sponsor

70 Previous Clinical Trials

8,219 Total Patients Enrolled

4 Trials studying Healthy Adults

85 Patients Enrolled for Healthy Adults

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still vacancies available for test subjects in this trial?

"While clinicaltrials.gov shows that this trial is no longer actively recruiting, with the initial posting on January 29th of 2022 and last update occurring November 17th of 2022, there are still 14 other studies currently looking for participants."

Answered by AI

To what demographic is this clinical trial open?

"Eligibility for this trial requires being a healthy adult aged between 18 and 55. Approximately 36 participants are needed to fulfil the criteria of the experiment."

Answered by AI

What risks are associated with Group 2 Treatment A for patients?

"Due to the limited evidence on safety and effectiveness, Group 2 Treatment A earned a score of 1."

Answered by AI

Will participants younger than seventy be considered for this medical research?

"This medical trial is restricted to individuals aged 18-55. If you are outside of this range, there may be other studies available; 1 for those under the age of 18 and 9 for people 65 or older."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PK Study to Assess Drug-drug Interaction Between Sitravatinib and a P-gp Inducer and an Inhibitor.

2022. "PK Study to Assess Drug-drug Interaction Between Sitravatinib and a P-gp Inducer and an Inhibitor.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05255276.