SSP-002358 Drug Interaction Study With Omeprazole

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Shire

ClinicalTrials.gov Identifier:

NCT01415349

First received: August 10, 2011

Last updated: June 6, 2014

Last verified: April 2014

History of Changes

Results First Received: June 1, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Healthy
Interventions:	Drug: SSP-002358 Drug: SSP-002358 + omeprazole

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
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

Participant Flow for 2 periods

Period 1: Treatment Period 1

	SSP-002358 First	SSP-002358 + Omeprazole First
STARTED	21	21
COMPLETED	21	19
NOT COMPLETED	0	2
Adverse Event	0	1
Withdrawal by Subject	0	1

Period 2: Treatment Period 2

	SSP-002358 First	SSP-002358 + Omeprazole First
STARTED	21	19
COMPLETED	21	19
NOT COMPLETED	0	0

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
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.

Baseline Measures

	Safety Analysis Set
Overall Participants Analyzed [Units: Participants]	42

Age [Units: Years] Mean (Standard Deviation)	27.4 (10.52)

Age, Customized [Units: Participants]
Between 18 and 55 years	42

Gender [Units: Participants]
Female	23
Male	19

Region of Enrollment [Units: Participants]
Netherlands	42

Outcome Measures

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1. Primary:

Maximum Plasma Concentration (Cmax) for SSP-002358 [ Time Frame: Assessed over 48 hours post-dose ]

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2. Primary:

Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) for SSP-002358 [ Time Frame: Assessed over 48 hours post-dose ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Results Point of Contact:

Name/Title: Study Physician
Organization: Shire Pharmaceutical
phone: 1 866 842 5335

Responsible Party:	Shire
ClinicalTrials.gov Identifier:	NCT01415349 History of Changes
Other Study ID Numbers:	SPD557-101 2011-001565-41 ( EudraCT Number )
Study First Received:	August 10, 2011
Results First Received:	June 1, 2012
Last Updated:	June 6, 2014

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