Status:
COMPLETED
Evaluating Relative Bioavailability of OC-01 (Varenicline) Nasal Spray as Compared to Orally Administered Varenicline
Lead Sponsor:
Oyster Point Pharma, Inc.
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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 strengt...
Detailed Description
This study was a Phase 1, open-label, randomized, 2-way crossover study to evaluate the relative bioavailability of OC-01 (varenicline) Nasal Spray compared to varenicline administered orally as varen...
Eligibility Criteria
Inclusion
- Body mass index between 18.0 and 32.0 kg/m2, inclusive.
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, ECG and laboratory tests.
- Have provided verbal and written informed consent
- If a female of childbearing potential who is not using an acceptable means of birth control (acceptable methods of contraception include: hormonal - oral, implantable, injectable, or transdermal contraceptives, mechanical - spermicide in conjunction with a barrier such as a diaphragm or condom, IUD, or surgical sterilization of partner), have a negative urine pregnancy test at the Screening Visit.
Exclusion
- Have had nasal or sinus surgery (including history of application of nasal cautery) or significant trauma to these areas.
- Have a vascularized polyp, severely deviated septum, chronic recurrent nosebleeds, or severe nasal airway obstruction as confirmed by intranasal examination at the Screening Visit.
- Any contraindication to varenicline according to the applicable label.
- Have severe renal impairment (estimated creatinine clearance less than 30mL per minute)
- Have current concomitant use of snuff, chewing tobacco, e-cigarettes or cigarettes/cigars during the study
- Have any condition or history that, in the opinion of the investigator, may interfere with study compliance, outcome measures, safety parameters, and/or the general medical condition of the subject
- Be a female who is pregnant, nursing an infant, or planning a pregnancy at the Screening Visit. Be a woman of childbearing potential who is not using an acceptable means of birth control; acceptable methods of contraception include: hormonal - oral, implantable, injectable, or transdermal contraceptives; mechanical - spermicide in conjunction with a barrier such as a diaphragm or condom; IUD; or surgical sterilization of partner.
- Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days prior to the Screening Visit.
Key Trial Info
Start Date :
August 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2019
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04072146
Start Date
August 26 2019
End Date
November 15 2019
Last Update
May 23 2022
Active Locations (1)
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1
United States, Miami Florida
Miami, Florida, United States, 33136