Trial Outcomes & Findings for SSP-002358 Drug Interaction Study With Omeprazole (NCT NCT01415349)
NCT ID: NCT01415349
Last Updated: 2021-06-10
Results Overview
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
42 participants
Primary outcome timeframe
Assessed over 48 hours post-dose
Results posted on
2021-06-10
Participant Flow
Participant milestones
| Measure |
SSP-002358 First
A single dose of 1 mg SSP-002358 in treatment period 1, a washout period, then a single dose of 1 mg SSP-002358 + a single dose of 40 mg Omeprazole in treatment period 2
|
SSP-002358 + Omeprazole First
A single dose of 1 mg SSP-002358 + a single dose of 40 mg Omeprazole in treatment period 1, a washout period, then a single dose of 1 mg SSP-002358 in treatment period 2
|
|---|---|---|
|
Treatment Period 1
STARTED
|
21
|
21
|
|
Treatment Period 1
COMPLETED
|
21
|
19
|
|
Treatment Period 1
NOT COMPLETED
|
0
|
2
|
|
Treatment Period 2
STARTED
|
21
|
19
|
|
Treatment Period 2
COMPLETED
|
21
|
19
|
|
Treatment Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
SSP-002358 First
A single dose of 1 mg SSP-002358 in treatment period 1, a washout period, then a single dose of 1 mg SSP-002358 + a single dose of 40 mg Omeprazole in treatment period 2
|
SSP-002358 + Omeprazole First
A single dose of 1 mg SSP-002358 + a single dose of 40 mg Omeprazole in treatment period 1, a washout period, then a single dose of 1 mg SSP-002358 in treatment period 2
|
|---|---|---|
|
Treatment Period 1
Adverse Event
|
0
|
1
|
|
Treatment Period 1
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
SSP-002358 Drug Interaction Study With Omeprazole
Baseline characteristics by cohort
| Measure |
Safety Analysis Set
n=42 Participants
Safety Analysis Set defined as all subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
|---|---|
|
Age, Continuous
|
27.4 years
STANDARD_DEVIATION 10.52 • n=5 Participants
|
|
Age, Customized
Between 18 and 55 years
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
42 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed over 48 hours post-dosePopulation: Pharmacokinetic Analysis Set defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Subjects who vomited or experienced significant diarrhea between dosing and 10 hours post-dose were excluded from the pharmacokinetic descriptive statistics and statistical analysis.
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Outcome measures
| Measure |
SSP-002358 Alone
n=36 Participants
All subjects that received only SSP-002358
|
SSP-002358 + Omeprazole
n=38 Participants
All subjects that received SSP-002358 + Omeprazole
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax) for SSP-002358
|
3.89 ng/ml
Standard Deviation 1.30
|
4.12 ng/ml
Standard Deviation 1.29
|
PRIMARY outcome
Timeframe: Assessed over 48 hours post-dosePopulation: Pharmacokinetic Analysis Set defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Subjects who vomited or experienced significant diarrhea between dosing and 10 hours post-dose were excluded from the pharmacokinetic descriptive statistics and statistical analysis.
Area under the plasma concentration versus time curve from time 0 to infinity. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Outcome measures
| Measure |
SSP-002358 Alone
n=36 Participants
All subjects that received only SSP-002358
|
SSP-002358 + Omeprazole
n=38 Participants
All subjects that received SSP-002358 + Omeprazole
|
|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) for SSP-002358
|
23.3 ng*h/ml
Standard Deviation 6.33
|
24.6 ng*h/ml
Standard Deviation 6.31
|
Adverse Events
SSP-002358 Alone
Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths
SSP-002358 + Omeprazole
Serious events: 0 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SSP-002358 Alone
n=40 participants at risk
All subjects that received only SSP-002358
|
SSP-002358 + Omeprazole
n=42 participants at risk
All subjects that received SSP-002358 + Omeprazole
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distention
|
7.5%
3/40
Safety Analysis Set defined as all subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
4.8%
2/42
Safety Analysis Set defined as all subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.5%
3/40
Safety Analysis Set defined as all subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
7.1%
3/42
Safety Analysis Set defined as all subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
|
Gastrointestinal disorders
Diarrhea
|
52.5%
21/40
Safety Analysis Set defined as all subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
61.9%
26/42
Safety Analysis Set defined as all subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
|
Gastrointestinal disorders
Flatulence
|
10.0%
4/40
Safety Analysis Set defined as all subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
4.8%
2/42
Safety Analysis Set defined as all subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
17.5%
7/40
Safety Analysis Set defined as all subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
9.5%
4/42
Safety Analysis Set defined as all subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
|
Gastrointestinal disorders
Nausea
|
15.0%
6/40
Safety Analysis Set defined as all subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
31.0%
13/42
Safety Analysis Set defined as all subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
|
General disorders
Catheter site related reaction
|
5.0%
2/40
Safety Analysis Set defined as all subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
4.8%
2/42
Safety Analysis Set defined as all subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
|
Nervous system disorders
Dizziness
|
5.0%
2/40
Safety Analysis Set defined as all subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
7.1%
3/42
Safety Analysis Set defined as all subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
|
Nervous system disorders
Headache
|
75.0%
30/40
Safety Analysis Set defined as all subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
78.6%
33/42
Safety Analysis Set defined as all subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
- Publication restrictions are in place
Restriction type: OTHER