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The purpose of this study is to evaluate the safety and tolerability of two dose levels of OP0201 and placebo, when administered intranasally in healthy adults subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug: OP0201 (30 mg) | Active Comparator | Cohort A- 30 mg per day X 14 days |
|
| Drug: Placebo | Placebo Comparator | Cohort A- 0 mg per day X 14 days Cohort B- 0 mg per day X 14 days |
|
| Drug: OP0201 (60 mg) | Active Comparator | Cohort B-60 mg per day X 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug: OP0201 | Combination Product | Drug OP0201 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With of Adverse Events | 21 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Systemic Exposure of DPPC: Observed DPPC Serum Concentration (µg/mL) by Nominal Timepoint | This will be evaluated by collecting blood on Day 1 baseline, Day 14 at 30 minutes pre-dose, and 5, 20, 35, and 50 minutes post-dose only in OP0201 Cohort B 60 mg per day | Day 1 and Day 14 |
| Evaluation of Systemic Exposure of CP: Observed CP Serum Concentrations (µM) by Nominal Timepoint |
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Inclusion Criteria includes but is not limited to:
Exclusion Criteria includes but is not limited to:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vince and Associates | Overland Park | Kansas | 66212 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Drug: OP0201 Cohort A 30 mg Per Day | Cohort A- 30 mg per day X 14 days Drug: OP0201: Drug OP0201 |
| FG001 | Drug: OP0201 Cohort B 60 mg Per Day | Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201 |
| FG002 | Drug: Placebo | 0 mg per day X 14 days Drug: Placebo: Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Drug: OP0201 Cohort A 30 mg Per Day | Cohort A- 30 mg per day X 14 days Drug: OP0201: Drug OP0201 |
| BG001 | Drug: OP0201 Cohort B 60 mg Per Day | Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With of Adverse Events | Posted | Count of Participants | Participants | 21 Days |
|
End of study (Day 21)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Drug: OP0201 Cohort A 30 mg Per Day | Cohort A- 30 mg per day X 14 days Drug: OP0201: Drug OP0201 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tinnitus | Ear and labyrinth disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Director | Novus Therapeutics | 949-679-1110 | study002@novustherapeutics.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 9, 2018 | Jan 13, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 3, 2019 | Jan 13, 2020 | SAP_001.pdf |
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| Drug: Placebo | Combination Product | Placebo |
|
This will be evaluated by collecting blood on Day 1 baseline, Day 14 at 30 minutes pre-dose, and 5, 20, 35, and 50 minutes post-dose only in OP0201 Cohort B 60 mg per day |
| Day 1 and Day 14 |
| Evaluation of Systemic Exposure of DPPC: Baseline-corrected DPPC Serum Concentration (µg/mL) by Nominal Timepoint | This will be evaluated by collecting blood on Day 1 baseline, Day 14 at 30 minutes pre-dose, and 5, 20, 35, and 50 minutes post-dose only in OP0201 Cohort B 60 mg per day | Day 1 and Day 14 |
| Evaluation of Systemic Exposure of CP: Baseline-corrected CP Serum Concentrations (µM) by Nominal Timepoint | This will be evaluated by collecting blood on Day 1 baseline, Day 14 at 30 minutes pre-dose, and 5, 20, 35, and 50 minutes post-dose only in OP0201 Cohort B 60 mg per day | Day 1 and Day 14 |
| BG002 | Drug: Placebo | 0 mg per day X 14 days Drug: Placebo: Placebo |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Evaluation of Systemic Exposure of DPPC: Observed DPPC Serum Concentration (µg/mL) by Nominal Timepoint | This will be evaluated by collecting blood on Day 1 baseline, Day 14 at 30 minutes pre-dose, and 5, 20, 35, and 50 minutes post-dose only in OP0201 Cohort B 60 mg per day | It is pre-specified to collect and report data for only "Cohort B" and "Placebo" Arms/Groups per protocol. The Number of participants analyzed for Cohort B at Day 14, 30 mins pre-dose and 5 mins post-dose is one less compared to other timepoints due to exclusion of serum samples that had missing collection times. | Posted | Mean | Standard Deviation | µg/mL | Day 1 and Day 14 |
|
|
|
| Secondary | Evaluation of Systemic Exposure of CP: Observed CP Serum Concentrations (µM) by Nominal Timepoint | This will be evaluated by collecting blood on Day 1 baseline, Day 14 at 30 minutes pre-dose, and 5, 20, 35, and 50 minutes post-dose only in OP0201 Cohort B 60 mg per day | It is pre-specified to collect and report data for only "Cohort B" and "Placebo" Arms/Groups per protocol. The Number of participants analyzed for Cohort B at Day 14, 30 mins pre-dose and 5 mins post-dose is one less compared to other timepoints due to exclusion of serum samples that had missing collection times. | Posted | Mean | Standard Deviation | µM | Day 1 and Day 14 |
|
|
|
| Secondary | Evaluation of Systemic Exposure of DPPC: Baseline-corrected DPPC Serum Concentration (µg/mL) by Nominal Timepoint | This will be evaluated by collecting blood on Day 1 baseline, Day 14 at 30 minutes pre-dose, and 5, 20, 35, and 50 minutes post-dose only in OP0201 Cohort B 60 mg per day | It is pre-specified to collect and report data for only "Cohort B" and "Placebo" Arms/Groups per protocol. The Number of participants analyzed for Cohort B at Day 14, 30 mins pre-dose and 5 mins post-dose is one less compared to other timepoints due to exclusion of serum samples that had missing collection times. | Posted | Mean | Standard Deviation | µg/mL | Day 1 and Day 14 |
|
|
|
| Secondary | Evaluation of Systemic Exposure of CP: Baseline-corrected CP Serum Concentrations (µM) by Nominal Timepoint | This will be evaluated by collecting blood on Day 1 baseline, Day 14 at 30 minutes pre-dose, and 5, 20, 35, and 50 minutes post-dose only in OP0201 Cohort B 60 mg per day | It is pre-specified to collect and report data for only "Cohort B" and "Placebo" Arms/Groups per protocol. The Number of participants analyzed for Cohort B at Day 14, 30 mins pre-dose and 5 mins post-dose is one less compared to other timepoints due to exclusion of serum samples that had missing collection times. | Posted | Mean | Standard Deviation | µM | Day 1 and Day 14 |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 5 |
| 12 |
| EG001 | Drug: OP0201 Cohort B 60 mg Per Day | Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201 | 0 | 12 | 0 | 12 | 9 | 12 |
| EG002 | Drug: Placebo | 0 mg per day X 14 days Drug: Placebo: Placebo | 0 | 6 | 0 | 6 | 4 | 6 |
| Toothache | Gastrointestinal disorders | Systematic Assessment |
|
| Feeling cold | General disorders | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
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| Olfactory test abnormal | Investigations | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | Systematic Assessment |
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| Somnolence | Nervous system disorders | Systematic Assessment |
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| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Nasal dryness | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Sneezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
No information, data or results shall be used by the Institution, Investigator or any other individual or entity other than the Sponsor. The use of Study Results by any party other than Sponsor requires prior written approval by the Sponsor.