Primary:to examine the effect of co-administration with omeprazole on the pharmacokinetics of SSP-002358.Secondary:to provide additional safety information for SSP-002358 when administered alone or in combination with omeprazole.
ID
Source
Brief title
Condition
- Gastrointestinal conditions NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Criteria for evaluation
Pharmacokinetics: pharmacokinetic parameters for SSP-002358
Safety: adverse events, vital signs, ECG-parameters, laboratory parameters,
physical examination
Secondary outcome
Not applicable.
Background summary
The purpose of the study is to evaluate if there is a change in the
pharmacokinetics (the way the body absorbs, distributes, breaks down and
eliminates medication) when SSP-002358 is taken alone and with another
medication, omeprazole. In addition, the study will also investigate how safe
the compound is and how well the compound is tolerated, when it is taken alone
and with another medication, omeprazole.
This study is not intended to improve the health of the volunteers, but is
necessary for the further development of the compound.
Study objective
Primary:
to examine the effect of co-administration with omeprazole on the
pharmacokinetics of SSP-002358.
Secondary:
to provide additional safety information for SSP-002358 when administered alone
or in combination with omeprazole.
Study design
Methodology
Design:
an open-label, randomized, two-period crossover drug interaction study
Procedures and assessments
Screening:
medical and medication history, physical examination, vital signs, height,
weight, 12-lead ECG, clinical laboratory, HBsAg, anti HCV, anti-HIV 1/2,
pregnancy test (females only) and urine drug and alcohol screen.
Observation period:
each period in clinic from -17 h up to 48 h after drug administration
Blood sampling:
Serial blood sampling through 48 h post-dose
Safety assessments:
adverse events; vital signs; physical examination, 12-lead ECG, clinical
laboratory and pregnancy test
Bioanalysis:
analysis of plasma SSP-002358 samples using a validated method by Sponsor
Intervention
Study Medication
Active substance: SSP-002358
Activity : 5-HT4 receptor agonist
Indication : gastroesophageal reflux disease
Strength : 0.5 mg
Dosage form: tablets
Active substance: omeprazole
Activity: proton pump inhibitor
Indication: gastroesophageal reflux disease and ulcers
Strength: 40 mg
Dosage form: capsules
Treatments
Regimen A: a single oral dose of 1 mg SSP-002358
Regimen B: a single oral dose of 1 mg SSP-002358 and a single dose of 40 mg
omeprazole
Study burden and risks
Not applicable.
Veedijk 58
2340 Turnhout
BE
Veedijk 58
2340 Turnhout
BE
Listed location countries
Age
Inclusion criteria
Age 18 - 55 year, BMI 18.5 - 30.0 kg/m2; no smoking.
Exclusion criteria
Suffering from: hepatitis B, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2011-001565-41-NL |
| CCMO | NL37509.056.11 |
| Other | zal nog geregistreerd worden op www.clinicaltrials.gov |