NCT00210093CompletedPhase 1
A Single-Center, Randomized, Crossover Pharmacokinetic Evaluation of the Effect of Single Doses of Intravenous INS37217, Nasally Inhaled INS37217 and Orally Inhaled INS37217 Solution in Healthy Volunteers
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 12
- Primary Endpoint
- plasma concentrations of INS37217
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
plasma concentrations of INS37217
Secondary Outcomes
- Pilot study - not specified
Investigators
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