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Evaluation of Safety and Pharmacodynamics of OP0201 Compared to Placebo in Healthy Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03828149
Recruitment Status : Completed
First Posted : February 4, 2019
Results First Posted : December 30, 2019
Last Update Posted : December 30, 2019
Sponsor:
Information provided by (Responsible Party):
Novus Therapeutics, Inc

Study Description
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Brief Summary:
Evaluation of Safety and Pharmacodynamics of OP0201 Compared to Placebo in Healthy Adults

Condition or disease Intervention/treatment Phase
Healthy Adults Combination Product: Drug:OP0201 Combination Product: Drug: Placebo Phase 1

Detailed Description:
Evaluation of Safety and Pharmacodynamics of OP0201 Compared to Placebo in Healthy Adults
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Official Title: Evaluation of Safety and Pharmacodynamics of OP0201 Compared to Placebo
Actual Study Start Date : February 8, 2019
Actual Primary Completion Date : March 7, 2019
Actual Study Completion Date : March 7, 2019
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Drug: OP0201
20 mg dose one time, followed by a washout and then a 0 mg dose one time, cross over design
 Combination Product: Drug:OP0201
Drug: OP0201
Placebo Comparator: Drug: Placebo
0 mg dose one time, followed by a washout and then a 20 mg dose one time, cross over design
 Combination Product: Drug: Placebo
Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Safety (Evaluation of Adverse Events) [ Time Frame: Days 1-9 ]
    All randomized participants who received at least one spray of study treatment in either nare were included in the safety analysis.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria includes but is not limited to:

  1. Body Mass Index (BMI) 18 to 30 and a minimum body weight of 50 kg at screening.
  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 includes but is not limited to:

  1. Known substance abuse (e.g., alcohol, licit or illicit drugs) within 96 weeks prior to screening visit
  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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03828149


Locations
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Germany
Cologne University Hospital
Cologne, Germany, 50937
Sponsors and Collaborators
Novus Therapeutics, Inc
  Study Documents (Full-Text)

Documents provided by Novus Therapeutics, Inc:
Study Protocol  [PDF] January 8, 2019
Statistical Analysis Plan  [PDF] February 26, 2019

More Information
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Additional Information:

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Responsible Party: Novus Therapeutics, Inc
ClinicalTrials.gov Identifier: NCT03828149    
Other Study ID Numbers: OP0201-C-001
First Posted: February 4, 2019    Key Record Dates
Results First Posted: December 30, 2019
Last Update Posted: December 30, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes