Evaluation of Safety and Pharmacodynamics of OP0201 Compared to Placebo in Healthy Adults
NCT ID: NCT03828149
Last Updated: 2019-12-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
17 participants
INTERVENTIONAL
2019-02-08
2019-03-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
TRIPLE
Study Groups
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Drug: OP0201
20 mg dose one time, followed by a washout and then a 0 mg dose one time, cross over design
Drug:OP0201
Drug: OP0201
Drug: Placebo
0 mg dose one time, followed by a washout and then a 20 mg dose one time, cross over design
Drug: Placebo
Drug: Placebo
Interventions
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Drug:OP0201
Drug: OP0201
Drug: Placebo
Drug: Placebo
Eligibility Criteria
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Inclusion Criteria
2. No history or presence of significant medical condition or a clinically significant abnormal finding, as determined by the investigator.
3. Negative urine pregnancy test at screening and baseline for females of childbearing potential
4. Agree to refrain from water immersion of the ears from the time of signed informed consent to the end of trial
5. Physiologic tympanogram type A (normal) or type C at screening visit
Exclusion Criteria
2. Positive urine drug screen at screening visit
3. Upper respiratory tract infection currently or within 6 weeks prior to screening visit
4. Allergy or sinus conditions (e.g., sinusitis, non-specific nasal inflammation) currently or within 6 weeks prior to screening visit
5. Claustrophobia that is sufficient to prevent them tolerating assessments while in a hypobaric/hyperbaric atmospheric pressure chamber
6. Smoker (e.g ., cigarettes, vapor) within the last 48 weeks prior to screening visit
7. Clinically significant findings on ear nose and throat exam
8. Gastroesophageal reflux disease currently or within 6 weeks prior to screening visit
9. Current diagnosis of sleep apnea
10. Evidence of craniofacial anomalies (eg, cleft palate, Down's Syndrome) that may interfere with ET function
11. Disorders with decreased mucociliary clearance or higher viscosity of the mucous (eg, cystic fibrosis, primary ciliary dyskinesia, Kartagener's syndrome)
18 Years
50 Years
ALL
Yes
Sponsors
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Novus Therapeutics, Inc
INDUSTRY
Responsible Party
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Locations
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Cologne University Hospital
Cologne, , Germany
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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OP0201-C-001
Identifier Type: -
Identifier Source: org_study_id