Evaluation of Safety and Pharmacodynamics of OP0201 Compared to Placebo in Healthy Adults
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ClinicalTrials.gov Identifier: NCT03828149 |
Recruitment Status :
Not yet recruiting
First Posted : February 4, 2019
Last Update Posted : February 5, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy Adults | Combination Product: Drug:OP0201 Combination Product: Drug: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 16 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 |
Estimated Study Start Date : | February 2019 |
Estimated Primary Completion Date : | March 2019 |
Estimated Study Completion Date : | March 2019 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Drug: OP0201
20mg one time dose, followed by a washout and then a single dose of the opposite intervention, cross over design
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Combination Product: Drug:OP0201
Drug: OP0201 |
Placebo Comparator: Drug: Placebo
0 mg one time dose, followed by a washout and then a single dose of the opposite intervention, cross over design
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Combination Product: Drug: Placebo
Drug: Placebo |
- Safety (Evaluation of Adverse Events) [ Time Frame: Days 1-9 ]
- Evaluate Eustachian Tube function using continuous tympanic impedance measure [ Time Frame: Days 1-9 ]

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria includes but is not limited to:
- Body Mass Index (BMI) 18 to 30 and a minimum body weight of 50 kg at screening.
- No history or presence of significant medical condition or a clinically significant abnormal finding, as determined by the investigator.
- Negative urine pregnancy test at screening and baseline for females of childbearing potential
- Agree to refrain from water immersion of the ears from the time of signed informed consent to the end of trial
- Physiologic tympanogram type A (normal) or type C at screening visit
Exclusion Criteria includes but is not limited to:
- Known substance abuse (e.g., alcohol, licit or illicit drugs) within 96 weeks prior to screening visit
- Positive urine drug screen at screening visit
- Upper respiratory tract infection currently or within 6 weeks prior to screening visit
- Allergy or sinus conditions (e.g., sinusitis, non-specific nasal inflammation) currently or within 6 weeks prior to screening visit
- Claustrophobia that is sufficient to prevent them tolerating assessments while in a hypobaric/hyperbaric atmospheric pressure chamber
- Smoker (e.g ., cigarettes, vapor) within the last 48 weeks prior to screening visit
- Clinically significant findings on ear nose and throat exam
- Gastroesophageal reflux disease currently or within 6 weeks prior to screening visit
- Current diagnosis of sleep apnea
- Evidence of craniofacial anomalies (eg, cleft palate, Down's Syndrome) that may interfere with ET function
- Disorders with decreased mucociliary clearance or higher viscosity of the mucous (eg, cystic fibrosis, primary ciliary dyskinesia, Kartagener's syndrome)

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
Contact: Amy Tran | 9492388090 | Study001@novustherapeutics.com |
Germany | |
Cologne University Hospital | Not yet recruiting |
Cologne, Germany, 50937 | |
Contact: Sebastian Meller 49-221-478-88790 sebastian.meller@uk-koeln.de | |
Principal Investigator: Jens P Klussman, MD |
Additional Information:
Responsible Party: | Novus Therapeutics, Inc |
ClinicalTrials.gov Identifier: | NCT03828149 History of Changes |
Other Study ID Numbers: |
OP0201-C-001 |
First Posted: | February 4, 2019 Key Record Dates |
Last Update Posted: | February 5, 2019 |
Last Verified: | December 2018 |
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 |