NCT01415349

SSP-002358 Drug Interaction Study With Omeprazole

Completed Phase 1 Results posted Last updated 10 June 2021

What this trial tests

Phase 1 trial testing SSP-002358 in Healthy in 42 participants. Completed in 28 September 2011.

Timeline

11 August 2011

Primary endpoint
28 September 2011

28 September 2011

Quick facts

Lead sponsor	Shire
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	42
Start date	11 August 2011
Primary completion	28 September 2011
Estimated completion	28 September 2011
Sites	1 location across Netherlands

Drugs / interventions tested

• SSP-002358 — full drug profile →
• SSP-002358 + omeprazole — full drug profile →

Conditions studied

• Healthy — all drugs for Healthy →

Sponsor

Shire — full company profile →

Who can join

Adults 18 to 55, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Maximum Plasma Concentration (Cmax) for SSP-002358 Primary · 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.

Group	Value	95% CI
SSP-002358 Alone	3.89	± 1.30
SSP-002358 + Omeprazole	4.12	± 1.29

Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) for SSP-002358 Primary · 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.

Group	Value	95% CI
SSP-002358 Alone	23.3	± 6.33
SSP-002358 + Omeprazole	24.6	± 6.31

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

SSP-002358 Alone

Serious: 0/40 (0%)

Deaths: —

SSP-002358 + Omeprazole

Serious: 0/42 (0%)

Deaths: —

Other adverse events (9 terms — click to expand)

Reaction	System	SSP-002358 Alone	SSP-002358 + Omeprazole
Headache	Nervous system disorders	—	—
Diarrhea	Gastrointestinal disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Gastrointestinal sounds abnormal	Gastrointestinal disorders	—	—
Flatulence	Gastrointestinal disorders	—	—
Abdominal distention	Gastrointestinal disorders	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Dizziness	Nervous system disorders	—	—
Catheter site related reaction	General disorders	—	—

Data from ClinicalTrials.gov NCT01415349 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A phase 1 randomized study evaluating the effect of omeprazole on the pharmacokinetics of a novel 5-hydroxytryptamine receptor 4 agonist, revexepride (SSP-002358), in healthy adults.
   Pierce D, Corcoran M, Velinova M, Hossack S, et al · · 2015 · cited 2× · PMID 25767373 · DOI 10.2147/dddt.s64621