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NCT03250182 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the PK and Safety of PT010 in Subjects With COPD Following Single and Repeat Dose
A Phase 1 study, sponsored by Pearl Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT03250182 is a Phase 1 study that has completed, run by Pearl Therapeutics. The registered enrollment target is 30 participants.
The verdict
NCT03250182, a Phase 1 study, has completed, sponsored by Pearl Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
This is a Phase I open-label, single center study to assess the PK and safety of BGF MDI 320/14.4/9.6 µg in subjects with moderate to severe COPD. Pharmacokinetics will be assessed following a single dose administration on the first treatment day (Day 1) and will be assessed again after 7 days of repeat dosing. This study includes a Screening Period of up to 28 days and a single Treatment Period of 8 days. A follow-up phone call will be conducted at least 5 days but no longer than 7 days after the last dose of study drug.
Interventions
- DRUG PT010
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2017-08-11 |
| Est. Completion | 2017-12-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03250182
The ClinicalTrials.gov registry entry for NCT03250182 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pearl Therapeutics, which has 31 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which PT010 is the first listed.
NCT03250182 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03250182 about?
NCT03250182 is a clinical study titled "A Study to Assess the PK and Safety of PT010 in Subjects With COPD Following Single and Repeat Dose". This is a Phase I open-label, single center study to assess the PK and safety of BGF MDI 320/14.4/9.6 µg in subjects with moderate to severe COPD. Pharmacokinetics will be assessed following a single dose administration on the first treatment day (Day 1) and will be assessed again after 7 days of re...
What is the current status of trial NCT03250182?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2017-08-11. Estimated completion is 2017-12-07.
What interventions are being tested in trial NCT03250182?
The interventions under investigation include: PT010 (DRUG).
Who is sponsoring clinical trial NCT03250182?
This trial is sponsored by Pearl Therapeutics, which has 31 total clinical trials registered on ClinicalTrials.gov.
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