Healthy
Conditions
Brief summary
This is a drug interaction study evaluating whether blood plasma concentrations of SSP-002358-base are altered when SSP-002358 is taken together with omeprazole.
Interventions
DRUGSSP-002358
1 mg, oral, once
DRUGSSP-002358 + omeprazole
SSP-002358 (1 mg) + omeprazole (40 mg) given orally, once
Sponsors
Shire
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age 18-55 years inclusive at the time of consent. 2. Subject is willing to comply with any applicable contraceptive requirements of the protocol and is: * Male, or * Non-pregnant, non-lactating female * Females must be at least 90 days post-partum or nulliparous.
Exclusion criteria
1. Any current or recurrent disease (eg, cardiovascular, renal, liver, gastrointestinal, malignancy or other conditions) that could affect the action, absorption, or disposition of the investigational product, or could affect clinical or laboratory assessments. 2. Any known or suspected intolerance or hypersensitivity to the investigational product or omeprazole, closely related compounds, or any of the stated ingredients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Plasma Concentration (Cmax) for SSP-002358 | Assessed over 48 hours post-dose | 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. |
| Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) for SSP-002358 | Assessed over 48 hours post-dose | 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. |
Countries
Netherlands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Safety Analysis Set 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. | 42 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Treatment Period 1 | Adverse Event | 0 | 1 |
| Treatment Period 1 | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Safety Analysis Set |
|---|---|
| Age, Continuous | 27.4 years STANDARD_DEVIATION 10.52 |
| Age, Customized Between 18 and 55 years | 42 Participants |
| Region of Enrollment Netherlands | 42 Participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 37 / 40 | 38 / 42 |
| serious Total, serious adverse events | 0 / 40 | 0 / 42 |
Outcome results
Primary
Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) for SSP-002358
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.
Time frame: Assessed over 48 hours post-dose
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SSP-002358 Alone | 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 |
| SSP-002358 + Omeprazole | Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) for SSP-002358 | 24.6 ng*h/ml | Standard Deviation 6.31 |
90% CI: [0.998, 1.08]Mixed Models Analysis
Primary
Maximum Plasma Concentration (Cmax) for SSP-002358
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.
Time frame: Assessed over 48 hours post-dose
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SSP-002358 Alone | Maximum Plasma Concentration (Cmax) for SSP-002358 | 3.89 ng/ml | Standard Deviation 1.3 |
| SSP-002358 + Omeprazole | Maximum Plasma Concentration (Cmax) for SSP-002358 | 4.12 ng/ml | Standard Deviation 1.29 |
90% CI: [0.966, 1.09]Mixed Models Analysis