Trial Outcomes & Findings for Evaluation of Safety and Pharmacodynamics of OP0201 Compared to Placebo in Healthy Adults (NCT NCT03828149)
NCT ID: NCT03828149
Last Updated: 2019-12-30
Results Overview
All randomized participants who received at least one spray of study treatment in either nare were included in the safety analysis.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
17 participants
Primary outcome timeframe
Days 1-9
Results posted on
2019-12-30
Participant Flow
Participant milestones
| Measure |
Drug: OP0201 First, Then Placebo
Participants first received 20mg one time dose of OP0201, followed by a washout and then a single dose of Placebo, cross over design
Drug:OP0201: Drug: OP0201
|
Drug: Placebo First, Then OP0201
Participants first received 0 mg one time dose of Placebo, followed by a washout and then a single dose of OP0201, cross over design
Drug: Placebo: Drug: Placebo
|
|---|---|---|
|
First Intervention (Single Dose)
STARTED
|
9
|
8
|
|
First Intervention (Single Dose)
COMPLETED
|
9
|
8
|
|
First Intervention (Single Dose)
NOT COMPLETED
|
0
|
0
|
|
Washout (6 Days)
STARTED
|
9
|
8
|
|
Washout (6 Days)
COMPLETED
|
9
|
8
|
|
Washout (6 Days)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (Single Dose)
STARTED
|
9
|
8
|
|
Second Intervention (Single Dose)
COMPLETED
|
9
|
8
|
|
Second Intervention (Single Dose)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Safety and Pharmacodynamics of OP0201 Compared to Placebo in Healthy Adults
Baseline characteristics by cohort
| Measure |
Drug: OP0201 First, Then Placebo
n=9 Participants
Participants first received 20mg one time dose, followed by a washout and then a single dose of the opposite intervention, cross over design
Drug:OP0201: Drug: OP0201
|
Drug: Placebo First, Then OP0201
n=8 Participants
Participants first received 0 mg one time dose, followed by a washout and then a single dose of the opposite intervention, cross over design
Drug: Placebo: Drug: Placebo
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.0 years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
24.5 years
STANDARD_DEVIATION 3.9 • n=7 Participants
|
25.8 years
STANDARD_DEVIATION 5.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Days 1-9All randomized participants who received at least one spray of study treatment in either nare were included in the safety analysis.
Outcome measures
| Measure |
Drug: OP0201
n=17 Participants
Participants received 20mg OP0201 one time dose at Day 1 or Day 8.
Drug:OP0201: Drug: OP0201
|
Drug: Placebo
n=17 Participants
Participants received 0 mg one time dose at Day 1 or Day 8.
Drug: Placebo: Drug: Placebo
|
|---|---|---|
|
Safety (Evaluation of Adverse Events)
|
17 Participants
|
17 Participants
|
Adverse Events
OP0201
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
OP0201
n=17 participants at risk
Participants received OP0201 20mg one time dose at either Day 1 or Day 8.
Drug:OP0201: Drug: OP0201
|
Placebo
n=17 participants at risk
Participants received Placebo 0 mg one time dose at either Day 1 or Day 8.
Drug: Placebo: Drug: Placebo
|
|---|---|---|
|
Ear and labyrinth disorders
Ear Pain
|
47.1%
8/17 • 9 days
The safety population included all randomized participants who received at least one spray of study treatment in either nare.
|
58.8%
10/17 • 9 days
The safety population included all randomized participants who received at least one spray of study treatment in either nare.
|
|
Ear and labyrinth disorders
Tympanic membrane hyperaemia
|
35.3%
6/17 • 9 days
The safety population included all randomized participants who received at least one spray of study treatment in either nare.
|
29.4%
5/17 • 9 days
The safety population included all randomized participants who received at least one spray of study treatment in either nare.
|
|
Ear and labyrinth disorders
Tympanic membrane disorder
|
23.5%
4/17 • 9 days
The safety population included all randomized participants who received at least one spray of study treatment in either nare.
|
17.6%
3/17 • 9 days
The safety population included all randomized participants who received at least one spray of study treatment in either nare.
|
|
Ear and labyrinth disorders
Ear discomfort
|
5.9%
1/17 • 9 days
The safety population included all randomized participants who received at least one spray of study treatment in either nare.
|
5.9%
1/17 • 9 days
The safety population included all randomized participants who received at least one spray of study treatment in either nare.
|
|
Nervous system disorders
Headache
|
5.9%
1/17 • 9 days
The safety population included all randomized participants who received at least one spray of study treatment in either nare.
|
23.5%
4/17 • 9 days
The safety population included all randomized participants who received at least one spray of study treatment in either nare.
|
|
Nervous system disorders
Dizziness
|
5.9%
1/17 • 9 days
The safety population included all randomized participants who received at least one spray of study treatment in either nare.
|
5.9%
1/17 • 9 days
The safety population included all randomized participants who received at least one spray of study treatment in either nare.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
11.8%
2/17 • 9 days
The safety population included all randomized participants who received at least one spray of study treatment in either nare.
|
5.9%
1/17 • 9 days
The safety population included all randomized participants who received at least one spray of study treatment in either nare.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/17 • 9 days
The safety population included all randomized participants who received at least one spray of study treatment in either nare.
|
11.8%
2/17 • 9 days
The safety population included all randomized participants who received at least one spray of study treatment in either nare.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal injury
|
5.9%
1/17 • 9 days
The safety population included all randomized participants who received at least one spray of study treatment in either nare.
|
0.00%
0/17 • 9 days
The safety population included all randomized participants who received at least one spray of study treatment in either nare.
|
|
General disorders
Fatigue
|
5.9%
1/17 • 9 days
The safety population included all randomized participants who received at least one spray of study treatment in either nare.
|
5.9%
1/17 • 9 days
The safety population included all randomized participants who received at least one spray of study treatment in either nare.
|
|
General disorders
Peripheral swelling
|
0.00%
0/17 • 9 days
The safety population included all randomized participants who received at least one spray of study treatment in either nare.
|
5.9%
1/17 • 9 days
The safety population included all randomized participants who received at least one spray of study treatment in either nare.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60