Phase 1
Completed N=42
SSP-002358 Drug Interaction Study With Omeprazole
Healthy
Source: ClinicalTrials.gov NCT01415349 ↗
Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Jul 2012
Primary outcomePrimary: Maximum Plasma Concentration (Cmax) for SSP-002358 — 3.89; 4.12 ng/ml
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Plasma Concentration (Cmax) for SSP-002358 |
3.89; 4.12 | — |
| PRIMARY Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) for SSP-002358 |
23.3; 24.6 | — |
Eligibility Criteria
Inclusion criteria
- Age 18-55 years inclusive at the time of consent.
- 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
- 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.
- Any known or suspected intolerance or hypersensitivity to the investigational product or omeprazole, closely related compounds, or any of the stated ingredients.
Data sourced from ClinicalTrials.gov (NCT01415349). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.