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NCT04072146 · ClinicalTrials.gov registry record · Phase 1
Evaluating Relative Bioavailability of OC-01 (Varenicline) Nasal Spray as Compared to Orally Administered Varenicline
A Phase 1 study, sponsored by Oyster Point Pharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT04072146: Completed Phase 1 study, sponsored by Oyster Point Pharma.
NCT04072146 is a Phase 1 study that has completed, run by Oyster Point Pharma. The registered enrollment target is 22 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04072146, a Phase 1 study, has completed, sponsored by Oyster Point Pharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
To assess the relative bioavailability of varenicline administered intranasally at its highest intended clinical strength compared to varenicline administered orally at its highest oral tablet strength.
Primary Outcome
Area under the curve from predose (time 0), 0.083, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post dose.
Interventions
- DRUG Vaenicline oral tablet 1 mg, then OC-01 (varenicline solution) nasal spray 0.12 mg
- DRUG OC-01 (varenicline solution) nasal spray 0.12 mg then Varenicline oral tablet 1 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2019-08-26 |
| Est. Completion | 2019-11-15 |
| Phase | Phase 1 |
What the finished NCT04072146 record still lists
NCT04072146 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 2 interventions - of which Vaenicline oral tablet 1 mg, then OC-01 (varenicline solution) nasal spray 0.12 mg is the first listed.
NCT04072146 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04072146 about?
NCT04072146 is a clinical study titled "Evaluating Relative Bioavailability of OC-01 (Varenicline) Nasal Spray as Compared to Orally Administered Varenicline". To assess the relative bioavailability of varenicline administered intranasally at its highest intended clinical strength compared to varenicline administered orally at its highest oral tablet strength.
What is the current status of trial NCT04072146?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2019-08-26. Estimated completion is 2019-11-15.
What interventions are being tested in trial NCT04072146?
The interventions under investigation include: Vaenicline oral tablet 1 mg, then OC-01 (varenicline solution) nasal spray 0.12 mg (DRUG), OC-01 (varenicline solution) nasal spray 0.12 mg then Varenicline oral tablet 1 mg (DRUG).
Who is sponsoring clinical trial NCT04072146?
This trial is sponsored by Oyster Point Pharma, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04072146's enrollment target sits among peer trials
22 1601st of 2000 higher than 386 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
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