Evaluating Relative Bioavailability of OC-01 (Varenicline) Nasal Spray as Compared to Orally Administered Varenicline
Condition: Healthy Subjects
Intervention: 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
Intervention description: Cross over bioavailability study; Cross over bioavailability study
Intervention MeSH terms: Pharmaceutical Solutions; Varenicline
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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.