CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 56 enrolled
Drug / intervention
Regimen A +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03311373
NCT03311373Phase 1Completed
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A Randomized, Open-label, Single-dose, Single-center, Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of PT010 Administered With and Without a Spacer, and With and Without Oral Charcoal

Pearl Therapeutics, Inc.·interventional·Posted Oct 17, 2017·Updated Jun 11, 2020

In Brief

A Phase 1 clinical trial evaluating Regimen A, Regimen B, and 2 other interventions for Chronic Obstructive Pulmonary Disease. Completed, enrolled 56 participants across 1 site.

Detailed Summary

Randomized, Open-label, Single-dose, Single-center, Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of PT010

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedOct 17, 2017
Enrollment StartOct 17, 2017
Primary CompletionDec 15, 2017
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 8.7 years ago

Interventions

Regimen Adrug

2 inhalations BGF MDI; no spacer device; no oral charcoal - reference formulation/total systemic exposure

Regimen Bdrug

2 inhalations BGF MDI; AeroChamber Plus Flow-Vu spacer device; no oral charcoal - test formulation/total systemic exposure

Regimen Cdrug

2 inhalations BGF MDI; no spacer device; with oral charcoal - reference formulation/lung exposure

Regimen Ddrug

2 inhalations BGF MDI; AeroChamber Plus Flow-Vu spacer device; with oral charcoal - test formulation/lung exposure