Effect of SSP-004184 (SPD602) on the Pharmacokinetics of Simvastatin in Healthy Adult Subjects

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Shire

ClinicalTrials.gov Identifier:

NCT01979185

First received: November 1, 2013

Last updated: December 16, 2014

Last verified: December 2014

History of Changes

Results First Received: December 16, 2014

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Open Label
Condition:	Healthy
Interventions:	Drug: Simvastatin Drug: SSP-004184SS

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
Simvastatin First	Subjects received Simvastatin 20mg in Period 1, followed by Simvastatin 20mg and SSP-004184SS 30mg/kg during Period 2.
Simvastatin + SSP-004184SS First	Subjects received Simvastatin 20mg and SSP-004184SS 30mg/kg in Period 1, followed by Simvastatin 20mg during Period 2.

Participant Flow for 2 periods

Period 1: Period 1

	Simvastatin First	Simvastatin + SSP-004184SS First
STARTED	15	15
COMPLETED	15	15
NOT COMPLETED	0	0

Period 2: Period 2

	Simvastatin First	Simvastatin + SSP-004184SS First
STARTED	15	15
COMPLETED	15	14 ^[1]
NOT COMPLETED	0	1
Not specified	0	1

^[1]	1 subject discontinued due to a positive drug test prior to receiving Simvastatin alone in Period 2.

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.
Safety Set: All subjects who had taken at least 1 dose of investigational product.

Reporting Groups

	Description
Simvastatin First	Subjects received Simvastatin 20mg in Period 1, followed by Simvastatin 20mg and SSP-004184SS 30mg/kg during Period 2.
Simvastatin + SSP-004184SS First	Subjects received Simvastatin 20mg and SSP-004184SS 30mg/kg in Period 1, followed by Simvastatin 20mg during Period 2.
Total	Total of all reporting groups

Baseline Measures

	Simvastatin First	Simvastatin + SSP-004184SS First	Total
Overall Participants Analyzed [Units: Participants]	15	15	30

Age [Units: Years] Mean (Standard Deviation)	39.1 (14.97)	39.6 (15.9)	39.3 (15.17)

Age, Customized [Units: Participants]
<=18 years	0	1	1
Between 18 and 65 years	15	14	29

Gender [Units: Participants]
Female	8	9	17
Male	7	6	13

Region of Enrollment [Units: Participants]
UNITED STATES	15	15	30

Outcome Measures

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1. Primary:

Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) for Simvastatin [ Time Frame: Over 72 hours post-dose ]

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2. Primary:

Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measureable Concentration (AUClast) of Simvastatin [ Time Frame: Over 72 hours post-dose ]

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3. Primary:

Maximum Plasma Concentration (Cmax) of Simvastatin [ Time Frame: Over 72 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 Development LLC
phone: +1 866 842 5335

Responsible Party:	Shire
ClinicalTrials.gov Identifier:	NCT01979185 History of Changes
Other Study ID Numbers:	SPD602-114
Study First Received:	November 1, 2013
Results First Received:	December 16, 2014
Last Updated:	December 16, 2014

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