Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02197975 · ClinicalTrials.gov registry record · Phase 1
Randomized, Crossover Safety and Pharmacokinetics Study of PT010
A Phase 1 study, sponsored by Pearl Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT02197975: Completed Phase 1 study, sponsored by Pearl Therapeutics.
NCT02197975 is a Phase 1 study that has completed, run by Pearl Therapeutics. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02197975, a Phase 1 study, has completed, sponsored by Pearl Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
Safety and Pharmacokinetics of Two Doses of PT010 in Healthy Adult Subjects of Japanese Descent Following a Single Dose and After Chronic Dosing for 7 Days.
Primary Outcome
The pharmacokinetic profile of PT010 will be assessed at the first day (Day 1) and last dose (Day 8) in each Treatment Period based on: * maximum plasma concentration (Cmax) * area under the plasma concentration-time curve from 0 to 12 hours (AUC0 12) * area under the plasma concentration-time curve from 0 to the time of the last measureable plasma concentration (AUC0-t) * area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC0-∞) (only calculated for Day 1) * time
Interventions
- DRUG Placebo MDI
- DRUG PT010 Dose 1
- DRUG PT010 Dose 2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2014-08 |
| Est. Completion | 2014-10 |
| Phase | Phase 1 |
What the finished NCT02197975 record still lists
NCT02197975 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo MDI is the first listed.
NCT02197975 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02197975 about?
NCT02197975 is a clinical study titled "Randomized, Crossover Safety and Pharmacokinetics Study of PT010". Safety and Pharmacokinetics of Two Doses of PT010 in Healthy Adult Subjects of Japanese Descent Following a Single Dose and After Chronic Dosing for 7 Days.
What is the current status of trial NCT02197975?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2014-08. Estimated completion is 2014-10.
What interventions are being tested in trial NCT02197975?
The interventions under investigation include: Placebo MDI (DRUG), PT010 Dose 1 (DRUG), PT010 Dose 2 (DRUG).
Who is sponsoring clinical trial NCT02197975?
This trial is sponsored by Pearl Therapeutics, which has 31 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02197975's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00573339 · 20 participants
Cardiac Magnetic Resonance Imaging (MRI) Normal Reference Control Group Testing
- NCT00692939 · 20 participants · Phase 1
Autologous Stem Cell Transplantation for Crohn's Disease
- NCT00967785 · 20 participants · Phase 1
A Phase I Study of Mozobil in the Treatment of Patients With WHIMS
- NCT01406691 · 20 participants · Phase 4
Light Flashes to Treat Delayed Sleep Phase Disorder (DSPD)
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia