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NCT03614455 · ClinicalTrials.gov registry record · Early Phase 1
Pharmacokinetics (PK) Drug Interaction Study of Milademetan and Itraconazole or Posaconazole in Healthy Participants
A Early Phase 1 study of Pharmacokinetics, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT03614455: Completed Early Phase 1 study of Pharmacokinetics, sponsored by Daiichi Sankyo.
NCT03614455 is a Early Phase 1 study of Pharmacokinetics that has completed, run by Daiichi Sankyo. The registered enrollment target is 36 participants, below the 61-participant average among 37 other Pharmacokinetics trials with a reported enrollment target (41% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03614455, a Early Phase 1 study of Pharmacokinetics, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
This will be an open-label, randomized, 3-treatment, 2-period, 2-sequence study in healthy subjects to evaluate the single-dose PK of milademetan when given as monotherapy and when administered with steady-state levels of the strong CYP3A4 inhibitors itraconazole or posaconazole. The duration of the study for each individual subject will be approximately 49 days from the start of Screening through Study Discharge. Subjects will remain in-house for up to 23 days, including 22 overnight stays.
Primary Outcome
Categories: alone (A), in sequence AB, in sequence AC
Conditions Studied
Interventions
- DRUG Itraconazole
- DRUG Posaconazole
- DRUG Milademetan
Study Locations (1)
Texas
- Covance Clinical Research Unit, Inc. - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2018-07-13 |
| Est. Completion | 2018-10-01 |
| Phase | Early Phase 1 |
What the finished NCT03614455 record still lists
NCT03614455 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 61-participant average among 37 other Pharmacokinetics trials with a reported enrollment target (41% lower).
The record links to 1 condition, with Pharmacokinetics appearing as the primary indexed condition, and to 3 interventions - of which Itraconazole is the first listed.
NCT03614455 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03614455 about?
NCT03614455 is a clinical study titled "Pharmacokinetics (PK) Drug Interaction Study of Milademetan and Itraconazole or Posaconazole in Healthy Participants". This will be an open-label, randomized, 3-treatment, 2-period, 2-sequence study in healthy subjects to evaluate the single-dose PK of milademetan when given as monotherapy and when administered with steady-state levels of the strong CYP3A4 inhibitors itraconazole or posaconazole. The duration of th...
What is the current status of trial NCT03614455?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 36 participants. The study started on 2018-07-13. Estimated completion is 2018-10-01.
What conditions does trial NCT03614455 study?
This clinical trial studies the following conditions: Pharmacokinetics.
What interventions are being tested in trial NCT03614455?
The interventions under investigation include: Itraconazole (DRUG), Posaconazole (DRUG), Milademetan (DRUG).
Who is sponsoring clinical trial NCT03614455?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03614455 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT03614455's enrollment target sits among peer trials
36 14th of 37 higher than 24 of 37 other Pharmacokinetics trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pharmacokinetics 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.
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