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NCT03498170 · ClinicalTrials.gov registry record · Phase 1
The Effect of Itraconazole on BCT197 Exposure in Healthy Male Participants
A Phase 1 study of Interaction, sponsored by Mereo BioPharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT03498170: Completed Phase 1 study of Interaction, sponsored by Mereo BioPharma.
NCT03498170 is a Phase 1 study of Interaction that has completed, run by Mereo BioPharma. The registered enrollment target is 16 participants, below the 23-participant average among 3 other Interaction trials with a reported enrollment target (30% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03498170, a Phase 1 study of Interaction, has completed, sponsored by Mereo BioPharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
An Open-label, 2-period, Single-sequence, Crossover Study to Evaluate the Effect of Multiple Oral Dosing of Itraconazole on BCT197 Systemic Exposure in Healthy Male Participants.
Primary Outcome
Period 1: Pre-dose and 1, 2, 4, 6, 12, 24, 36, 48, 72, 96, 144 and 168 hours post BCT197 dose on Day 1. Period 2: Pre-dose and 1, 2, 4, 6, 12, 24, 36, 48, 72, 96, 144, 168 and 192 hours post BCT197 dose on Day 7.
Conditions Studied
Interventions
- DRUG Itraconazole 200 mg
- DRUG BCT197
Study Locations (1)
Florida
- inVentiv Health Clinical Research Services LLC - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2018-03-19 |
| Est. Completion | 2018-05-09 |
| Phase | Phase 1 |
What the finished NCT03498170 record still lists
NCT03498170 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 23-participant average among 3 other Interaction trials with a reported enrollment target (30% lower).
The record links to 1 condition, with Interaction appearing as the primary indexed condition, and to 2 interventions - of which Itraconazole 200 mg is the first listed.
NCT03498170 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT03498170 about?
NCT03498170 is a clinical study titled "The Effect of Itraconazole on BCT197 Exposure in Healthy Male Participants". An Open-label, 2-period, Single-sequence, Crossover Study to Evaluate the Effect of Multiple Oral Dosing of Itraconazole on BCT197 Systemic Exposure in Healthy Male Participants.
What is the current status of trial NCT03498170?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2018-03-19. Estimated completion is 2018-05-09.
What conditions does trial NCT03498170 study?
This clinical trial studies the following conditions: Interaction.
What interventions are being tested in trial NCT03498170?
The interventions under investigation include: Itraconazole 200 mg (DRUG), BCT197 (DRUG).
Who is sponsoring clinical trial NCT03498170?
This trial is sponsored by Mereo BioPharma, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03498170 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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