Healthy
Conditions
Brief summary
The purpose of this trial is to characterize the pharmacokinetics of INS37217 following intravenous, intranasal, and inhalation administration and to calculate the relative bioavailability of INS37217 when administered via oral or nasal inhalation.
Interventions
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Inclusion criteria
* Are current nonsmokers or previous smokers who have not smoked within 6 months and who do not have greater than or equal to a 10 pack-year history of tobacco use * Are within 20% of their ideal body weight * Are healthy on the basis of a pre-trial physical examination
Exclusion criteria
* History or suspicion of recent alcohol, barbiturate, amphetamine or narcotic abuse or a positive urine drug test at study screening * History of cardiac arrhythmias, any pathological abnormality on the ECG, bronchospasm, diabetes mellitus, thyrotoxicosis, Parkinsonism, asthma, COPD or cardiovascular disease significant drug allergy * Subject with a physical obstruction in the nose * Use of concomitant medication other than hormonal contraceptives and multi-vitamins * Subjects with a current upper respiratory illness or infection for the 2 weeks prior to screening or any chronic respiratory illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentrations of INS37217 | — |
Secondary
| Measure | Time frame |
|---|---|
| Pilot study - not specified | — |
Outcome results
None listed