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NCT04887194 · ClinicalTrials.gov registry record · Phase 1

PK Study to Assess Drug-drug Interaction and QTc Between Sitravatinib and a Cocktail of Substrates

A Phase 1 study, sponsored by Mirati Therapeutics.

Completed
Registry status
Phase 1
Development phase
40
Enrollment target

NCT04887194: Completed Phase 1 study, sponsored by Mirati Therapeutics.

NCT04887194 is a Phase 1 study that has completed, run by Mirati Therapeutics. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04887194, a Phase 1 study, has completed, sponsored by Mirati Therapeutics.

COMPLETED
Registry status
Phase 1
Development phase
40 participants
Enrollment target

Study Summary

Study 516-010 is an open-label Phase 1, drug-drug interaction and QTc study evaluating the effect of sitravatinib on probe substrates for CYP450 enzymes and BCRP and P-gp transporters.

Primary Outcome

(warfarin, dextromethorphan, midazolam, digoxin, and rosuvastatin) derived from the plasma concentration time profile before and after oral administration of sitravatinib

Interventions

  • DRUG Midazolam
  • DRUG Digoxin
  • DRUG Warfarin
  • DRUG Dextromethorphan
  • DRUG Sitravatinib

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2021-04-08
Est. Completion 2022-12-22
Phase Phase 1
Mirati Therapeutics

49 total trials

What the finished NCT04887194 record still lists

NCT04887194 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).

The record links to 0 conditions, and to 5 interventions - of which Midazolam is the first listed.

NCT04887194 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04887194 about?

NCT04887194 is a clinical study titled "PK Study to Assess Drug-drug Interaction and QTc Between Sitravatinib and a Cocktail of Substrates". Study 516-010 is an open-label Phase 1, drug-drug interaction and QTc study evaluating the effect of sitravatinib on probe substrates for CYP450 enzymes and BCRP and P-gp transporters.

What is the current status of trial NCT04887194?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2021-04-08. Estimated completion is 2022-12-22.

What interventions are being tested in trial NCT04887194?

The interventions under investigation include: Midazolam (DRUG), Digoxin (DRUG), Warfarin (DRUG), Dextromethorphan (DRUG), Sitravatinib (DRUG).

Who is sponsoring clinical trial NCT04887194?

This trial is sponsored by Mirati Therapeutics, which has 49 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04887194's enrollment target sits among peer trials

40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04887194, the US trial registry maintained by the National Library of Medicine. NCT04887194 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.