Pharmacokinetic and Safety Study of HYLENEX Recombinant-Augmented Subcutaneous Ceftriaxone Administration - Study Results

Pharmacokinetic and Safety Study of HYLENEX Recombinant-Augmented Subcutaneous Ceftriaxone Administration (INFUSE-Cftrx)

This study has been completed.

Study NCT00493220 Information provided by Baxter Healthcare Corporation

First Received on June 26, 2007. Last Updated on October 24, 2011 History of Changes

Results First Received: September 12, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Pharmacokinetics Study; Intervention Model: Crossover Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Healthy
Interventions:	Drug: SC HYLENEX and Ceftriaxone Drug: SC Placebo and Ceftriaxone Drug: IV Ceftriaxone

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
Healthy volunteers recruited via subject-initiated telephone or internet contacts or visits to Phase I unit. Those considered potentially eligible were, after obtaining consent, screened in detail to determine eligibility against protocol eligibility criteria.

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
HYLENEX SC, Placebo SC, IV	subcutaneous HYLENEX and ceftriaxone as first intervention, subcutaneous placebo and ceftriaxone as second intervention, intravenous ceftriaxone as third intervention
HYLENEX SC, IV, Placebo SC	subcutaneous HYLENEX and ceftriaxone as first intervention, intravenous ceftriaxone as second intervention, subcutaneous placebo and ceftriaxone as third intervention
Placebo SC, HYLENEX SC, IV	subcutaneous placebo and ceftriaxone as first intervention, subcutaneous HYLENEX and ceftriaxone as second intervention, intravenous ceftriaxone as third intervention
Placebo SC, IV, HYLENEX SC	subcutaneous placebo and ceftriaxone as first intervention, intravenous ceftriaxone as second intervention, subcutaneous HYLENEX and ceftriaxone as third intervention
IV, HYLENEX SC, Placebo SC	intravenous ceftriaxone as first intervention, subcutaneous HYLENEX and ceftriaxone as second intervention, subcutaneous placebo and ceftriaxone as third intervention
IV, Placebo SC, HYLENEX SC	intravenous ceftriaxone as first intervention, subcutaneous placebo and ceftriaxone as second intervention, subcutaneous HYLENEX and ceftriaxone as third intervention

Participant Flow for 6 periods

Period 1: First Intervention

	HYLENEX SC, Placebo SC, IV	HYLENEX SC, IV, Placebo SC	Placebo SC, HYLENEX SC, IV	Placebo SC, IV, HYLENEX SC	IV, HYLENEX SC, Placebo SC	IV, Placebo SC, HYLENEX SC
STARTED	5	5	5	5	5	5
COMPLETED	5	5	5	5	5	5
NOT COMPLETED	0	0	0	0	0	0

Period 2: First 7-Day Washout & Safety Follow-up

	HYLENEX SC, Placebo SC, IV	HYLENEX SC, IV, Placebo SC	Placebo SC, HYLENEX SC, IV	Placebo SC, IV, HYLENEX SC	IV, HYLENEX SC, Placebo SC	IV, Placebo SC, HYLENEX SC
STARTED	5	5	5	5	5	5
COMPLETED	5	5	5	5	5	5
NOT COMPLETED	0	0	0	0	0	0

Period 3: Second Intervention

	HYLENEX SC, Placebo SC, IV	HYLENEX SC, IV, Placebo SC	Placebo SC, HYLENEX SC, IV	Placebo SC, IV, HYLENEX SC	IV, HYLENEX SC, Placebo SC	IV, Placebo SC, HYLENEX SC
STARTED	5	5	5	5	5	5
COMPLETED	5	5	5	5	5	5
NOT COMPLETED	0	0	0	0	0	0

Period 4: Second 7-Day Washout & Safety Follow-up

	HYLENEX SC, Placebo SC, IV	HYLENEX SC, IV, Placebo SC	Placebo SC, HYLENEX SC, IV	Placebo SC, IV, HYLENEX SC	IV, HYLENEX SC, Placebo SC	IV, Placebo SC, HYLENEX SC
STARTED	5	5	5	5	5	5
COMPLETED	5	5	5	5	5	5
NOT COMPLETED	0	0	0	0	0	0

Period 5: Third Intervention

	HYLENEX SC, Placebo SC, IV	HYLENEX SC, IV, Placebo SC	Placebo SC, HYLENEX SC, IV	Placebo SC, IV, HYLENEX SC	IV, HYLENEX SC, Placebo SC	IV, Placebo SC, HYLENEX SC
STARTED	5	5	5	5	5	5
COMPLETED	4	5	5	5	5	5
NOT COMPLETED	1	0	0	0	0	0
Withdrawal by Subject	1	0	0	0	0	0

Period 6: Final 7-Day Safety Follow-up

	HYLENEX SC, Placebo SC, IV	HYLENEX SC, IV, Placebo SC	Placebo SC, HYLENEX SC, IV	Placebo SC, IV, HYLENEX SC	IV, HYLENEX SC, Placebo SC	IV, Placebo SC, HYLENEX SC
STARTED	4	5	5	5	5	5
COMPLETED	4	5	5	5	5	5
NOT COMPLETED	0	0	0	0	0	0

Baseline Characteristics

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Reporting Groups

	Description
HYLENEX SC, Placebo SC, IV	subcutaneous HYLENEX and ceftriaxone as first intervention, subcutaneous placebo and ceftriaxone as second intervention, intravenous ceftriaxone as third intervention
HYLENEX SC, IV, Placebo SC	subcutaneous HYLENEX and ceftriaxone as first intervention, intravenous ceftriaxone as second intervention, subcutaneous placebo and ceftriaxone as third intervention
Placebo SC, HYLENEX SC, IV	subcutaneous placebo and ceftriaxone as first intervention, subcutaneous HYLENEX and ceftriaxone as second intervention, intravenous ceftriaxone as third intervention
Placebo SC, IV, HYLENEX SC	subcutaneous placebo and ceftriaxone as first intervention, intravenous ceftriaxone as second intervention, subcutaneous HYLENEX and ceftriaxone as third intervention
IV, HYLENEX SC, Placebo SC	intravenous ceftriaxone as first intervention, subcutaneous HYLENEX and ceftriaxone as second intervention, subcutaneous placebo and ceftriaxone as third intervention
IV, Placebo SC, HYLENEX SC	intravenous ceftriaxone as first intervention, subcutaneous placebo and ceftriaxone as second intervention, subcutaneous HYLENEX and ceftriaxone as third intervention

Baseline Measures

	HYLENEX SC, Placebo SC, IV	HYLENEX SC, IV, Placebo SC	Placebo SC, HYLENEX SC, IV	Placebo SC, IV, HYLENEX SC	IV, HYLENEX SC, Placebo SC	IV, Placebo SC, HYLENEX SC	Total
Number of Participants [units: participants]	5	5	5	5	5	5	30
Age [units: participants]
<=18 years	0	0	0	0	0	0	0
Between 18 and 65 years	5	5	5	5	5	5	30
>=65 years	0	0	0	0	0	0	0
Age [units: years] Mean ± Standard Deviation	32.2 ± 10.6	37.6 ± 4.0	34.2 ± 11.5	34.8 ± 17.5	34.8 ± 11.0	33.2 ± 8.0	34.5 ± 10.3
Gender [units: participants]
Female	1	0	1	1	2	0	5
Male	4	5	4	4	3	5	25
Region of Enrollment [units: participants]
United States	5	5	5	5	5	5	30

Outcome Measures

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1. Primary:

AUC0-t [ Time Frame: Start of ceftriaxone administration through time of last measureable plasma ceftriaxone concentration ]

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2. Primary:

AUC0-inf [ Time Frame: from the start of ceftriaxone administration to infinity ]

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3. Secondary:

Cmax [ Time Frame: at the time of the highest measured plasma ceftriaxone concentration ]

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4. Secondary:

Tmax [ Time Frame: from start of ceftriaxone administration until time of maximum measured plasma ceftriaxone concentration ]

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Serious Adverse Events

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Other Adverse Events

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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: For this study, Baxter requires a review of any planned PI results communications (eg, for confidential information) up to 90 days prior to submission or communication. Baxter may request an additional delay of up to 60 days (eg, to allow for intellectual property protection).

Limitations and Caveats

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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Results Point of Contact:

Name/Title: George Harb, MD, MPH
Organization: Baxter Healthcare Corporation
e-mail: george_harb@baxter.com

Publications of Results:

Harb G, Lebel F, Battikha J, Thackara JW. Safety and pharmacokinetics of subcutaneous ceftriaxone administered with or without recombinant human hyaluronidase (rHuPH20) versus intravenous ceftriaxone administration in adult volunteers. Curr Med Res Opin. 2010 Feb;26(2):279-88.

Responsible Party:	Geroge E. Harb, MD, Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:	NCT00493220 History of Changes
Other Study ID Numbers:	1838-004
Study First Received:	June 26, 2007
Results First Received:	September 12, 2011
Last Updated:	October 24, 2011
Health Authority:	United States: Food and Drug Administration