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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 is a Phase 1 study that has completed, run by Oyster Point Pharma. The registered enrollment target is 22 participants.

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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.

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

FieldValue
Enrollment Target 22 participants
Start Date 2019-08-26
Est. Completion 2019-11-15
Phase Phase 1

Sponsor

Oyster Point Pharma

10 total trials

What the Registry Record Tells You About NCT04072146

The ClinicalTrials.gov registry entry for NCT04072146 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Oyster Point Pharma, which has 10 total studies on file at ClinicalTrials.gov.

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 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.