Who is sponsoring NCT04072146?

NCT04072146 is sponsored by Oyster Point Pharma, Inc..

What drugs are being tested in NCT04072146?

Interventions in NCT04072146: Vaenicline oral tablet 1 mg, then OC-01 (varenicline solution) nasal spray 0.12 mg, OC-01 (varenicline solution) nasal spray 0.12 mg then Varenicline oral tablet 1 mg.

What condition does NCT04072146 study?

NCT04072146 studies Healthy Subjects.

Is NCT04072146 still recruiting?

NCT04072146 is currently completed. Last updated 23 May 2022.

Are results published for NCT04072146?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-05-23 · How we verify

NCT04072146

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Evaluating Relative Bioavailability of OC-01 (Varenicline) Nasal Spray as Compared to Orally Administered Varenicline

Completed Phase 1 Results posted Last updated 23 May 2022

What this trial tests

Phase 1 trial testing Vaenicline oral tablet 1 mg, then OC-01 (varenicline solution) nasal spray 0.12 mg in Healthy Subjects in 22 participants. Completed in 15 November 2019.

Timeline

26 August 2019

Primary endpoint
15 November 2019

15 November 2019

Quick facts

Lead sponsor	Oyster Point Pharma, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	other
Enrollment	22
Start date	26 August 2019
Primary completion	15 November 2019
Estimated completion	15 November 2019
Sites	1 location across United States

Drugs / interventions tested

Vaenicline oral tablet 1 mg, then OC-01 (varenicline solution) nasal spray 0.12 mg — full drug profile →
OC-01 (varenicline solution) nasal spray 0.12 mg then Varenicline oral tablet 1 mg — full drug profile →

Conditions studied

Healthy Subjects — all drugs for Healthy Subjects →

Sponsor

Oyster Point Pharma, Inc. — full company profile →

Who can join

Adults 18 to 65, any sex, with Healthy Subjects. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

AUC0-t Primary · Blood samples were taken 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.

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.

Group	Value	95% CI
Varenicline Oral Tablet 1 mg	4.49	± 3.42
OC-01 (Varenicline) Nasal Spray 0.12 mg	98.74	± 25.49

AUC0-inf Primary · Blood samples were taken 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.

AUC0-inf taken at 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.

Group	Value	95% CI
OC-01 (Varenicline) Nasal Spray 0.12 mg	8.3	± 4.09
Varenicline Oral Tablet 1 mg	102.83	± 16.82

Cmax Primary · Blood samples were taken 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.

Cmax taken at 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.

Group	Value	95% CI
OC-01 (Varenicline) Nasal Spray 0.12 mg	0.34	± 0.13
Varenicline Oral Tablet 1 mg	4.63	± 0.93

Tmax Primary · Blood samples were taken 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.

Tmax taken at 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.

Group	Value	95% CI
OC-01 (Varenicline) Nasal Spray 0.12 mg	2.0	0.3 – 3.0
Varenicline Oral Tablet 1 mg	3	1 – 6

Creatine Shift From Normal at Baseline to Abnormal After 2 Hours Post-treatment Secondary · Baseline to 2 hours post treatment

Creatine shift from baseline to 2 hours post treatment. Elevated creatinine may indicate impaired kidney function.

Group	Value	95% CI
Varenicline Oral Tablet 1mg, Then OC-01 (Varenicline Solution) Nasal Spray 0.12 mg	3
OC-01 (Varenicline Solution) Nasal Spray 0.12 mg, Then Varenicline Oral Tablet 1 mg	3

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse Events were collected from the first dose of study drug administration until the final study visit (60 days).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

OC- 01 (Varenicline) Nasal Spray 0.12 mg

Serious: 0/21 (0%)

Deaths: 0/21

Varenicline Oral Tablet 1 mg

Serious: 0/22 (0%)

Deaths: 0/22

Other adverse events (17 terms — click to expand)

Reaction	System	OC- 01 (Varenicline) Nasal…	Varenicline Oral Tablet 1 mg
Dizziness	Nervous system disorders	—	—
Sneezing	Respiratory, thoracic and mediastinal disorders	—	—
cough	Respiratory, thoracic and mediastinal disorders	—	—
nausea	Gastrointestinal disorders	—	—
vomiting	Gastrointestinal disorders	—	—
somnolence	Nervous system disorders	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—
Dry mouth	Gastrointestinal disorders	—	—
Chills	General disorders	—	—
Feeling cold	General disorders	—	—
Scratch	Injury, poisoning and procedural complications	—	—
Head discomfort	Nervous system disorders	—	—
Headache	Nervous system disorders	—	—
Dry throat	Respiratory, thoracic and mediastinal disorders	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—
Nasal pruritus	Respiratory, thoracic and mediastinal disorders	—	—
Rhinorrhea	Respiratory, thoracic and mediastinal disorders	—	—

Data from ClinicalTrials.gov NCT04072146 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

A Phase I, Open-label, Randomized, 2-Way Crossover Study to Evaluate the Relative Bioavailability of Intranasal and Oral Varenicline.
Nau J, Wyatt DJ, Rollema H, Crean CS. · · 2021 · cited 11× · PMID 34456060 · DOI 10.1016/j.clinthera.2021.07.020

Verify or expand the search:

Other recruiting trials for Healthy Subjects

Currently open trials in the same condition.

NCT07222020 — Phase 1 Study of Intravaginal KB15A · Phase 1 · recruiting
NCT07350538 — The Critical Link Between Gut Microbiome Dysfunction, Cravings and Relapse: RECLAIM-GUT TRIAL · NA · active not recruiting
NCT07304791 — This is a Phase 1, Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Pharmacokinetics (PK), and P · Phase 1 · recruiting
NCT07059858 — Bladder and Bowel Functions, Participation and Quality of Life in Children With Intellectual Disabilities · recruiting
NCT07331389 — A Drug-Drug Interaction Study of HDM1002 and Metformin, Empagliflozin, Midazolam, Valsartan, and Warfarin · Phase 1 · recruiting

Other Oyster Point Pharma, Inc. trials

Trials by the same sponsor.

NCT06329687 — A Study Evaluating the Safety of the Nasal Pump · Phase 4 · terminated
NCT05918406 — Phase 4 Study Evaluating the Safety of the Nasal Guide With Tyrvaya · Phase 4 · completed
NCT04957758 — Phase 2 Clinical Trial to Evaluate OC-01 Nasal Spray in Subjects With Neurotrophic Keratopathy · Phase 2 · completed
NCT04036292 — Evaluation of the Efficacy and Safety of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease · Phase 3 · completed
NCT03873246 — Clinical Trial to Evaluate the Chronic Efficacy of OC-01 Nasal Spray on Signs of Dry Eye Disease (The MYSTIC Study) · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04072146 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Oyster Point Pharma, Inc.
Last refreshed: 23 May 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04072146.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing