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NCT04118842 · ClinicalTrials.gov registry record · Phase 1
A Study in Healthy Subjects to Assess the Pharmacokinetics of Savolitinib When Administered Alone and in Combination With Rifampicin
A Phase 1 study of Solid Tumors, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT04118842: Completed Phase 1 study of Solid Tumors, sponsored by AstraZeneca.
NCT04118842 is a Phase 1 study of Solid Tumors that has completed, run by AstraZeneca. The registered enrollment target is 40 participants, below the 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04118842, a Phase 1 study of Solid Tumors, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a phase I, open-label, 3 treatment period, fixed-sequence study in healthy non-Japanese male subjects, aged 18 to 65 years (inclusive), performed at a single study centre. Treatment Period 1 will establish the single dose pharmacokinetic (PK) profile of savolitinib. Dosing of daily rifampicin during Treatment Period 2 will result in maximal induction of the CYP450 enzymes including CYP3A4. Treatment Period 3 will then establish the single dose PK profile of savolitinib under maximum CYP450 induction conditions. Comparison of the PK profile of savolitinib between Treatment Period 1 and Treatment Period 3 will quantify the effect of CYP450 enzyme induction.
Primary Outcome
To assess the effect of rifampicin on the PK of savolitinib
Conditions Studied
Interventions
- DRUG Savolitinib
- DRUG Rifampicin
Study Locations (1)
Maryland
- Research Site - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2019-10-17 |
| Est. Completion | 2020-02-26 |
| Phase | Phase 1 |
What the finished NCT04118842 record still lists
NCT04118842 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 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Solid Tumors appearing as the primary indexed condition, and to 2 interventions - of which Savolitinib is the first listed.
NCT04118842 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04118842 about?
NCT04118842 is a clinical study titled "A Study in Healthy Subjects to Assess the Pharmacokinetics of Savolitinib When Administered Alone and in Combination With Rifampicin". This is a phase I, open-label, 3 treatment period, fixed-sequence study in healthy non-Japanese male subjects, aged 18 to 65 years (inclusive), performed at a single study centre. Treatment Period 1 will establish the single dose pharmacokinetic (PK) profile of savolitinib. Dosing of daily rifampici...
What is the current status of trial NCT04118842?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2019-10-17. Estimated completion is 2020-02-26.
What conditions does trial NCT04118842 study?
This clinical trial studies the following conditions: Solid Tumors.
What interventions are being tested in trial NCT04118842?
The interventions under investigation include: Savolitinib (DRUG), Rifampicin (DRUG).
Who is sponsoring clinical trial NCT04118842?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04118842 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Solid Tumors
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04118842's enrollment target sits among peer trials
40 96th of 125 higher than 26 of 125 other Solid Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Solid Tumors 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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A Study of XB371 Administered in Participants With Locally Advanced or Metastatic Solid Tumors
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A First-in-Human Study of BG-C0902 Alone and in Combination With Other Therapeutic Agents in Patients With Advanced Solid Tumors
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JAB-2485 Activity in Adult Patients With Advanced Solid Tumors
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A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
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-
Study of AUBE00 in Patients With Solid Tumors
RECRUITING · Phase 1
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