A Study of the Pharmacokinetics of Two Formulations of MK-1006 (MK-1006-010 AM1)(COMPLETED)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merck

ClinicalTrials.gov Identifier:

NCT00979459

First received: September 17, 2009

Last updated: September 10, 2012

Last verified: September 2012

History of Changes

Results First Received: July 12, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Pharmacokinetics Study; Intervention Model: Crossover Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Type 2 Diabetes
Interventions:	Drug: MK-1006 DFC Drug: MK-1006 FCT

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
MK-1006 DFC, Then MK-1006 FCT	Participants received a single dose of four 20 mg MK-1006 dry filled capsules (DFC) followed by a single dose of two 40 mg MK-1006 film coated tablets (FCT) after a 7 day washout period.
MK-1006 FCT, Then MK-1006 DFC	Participants received a single dose of two 40 mg film coated tablets (FCT) of MK-1006 followed by a single dose of four 20 mg MK-1006 dry filled capsules (DFC) after a 7 day washout period.

Participant Flow for 3 periods

Period 1: First Intervention

	MK-1006 DFC, Then MK-1006 FCT	MK-1006 FCT, Then MK-1006 DFC
STARTED	6	6
COMPLETED	6	6
NOT COMPLETED	0	0

Period 2: 7-day Washout Period

	MK-1006 DFC, Then MK-1006 FCT	MK-1006 FCT, Then MK-1006 DFC
STARTED	6	6
COMPLETED	6	6
NOT COMPLETED	0	0

Period 3: Second Intervention

	MK-1006 DFC, Then MK-1006 FCT	MK-1006 FCT, Then MK-1006 DFC
STARTED	6	6
COMPLETED	6	6
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
All Participants	Includes participants who were randomized to receive either a single dose of four 20 mg MK-1006 DFC followed by a single dose of two 40 mg MK-1006 FCT or a single dose of four 20 mg MK-1006 FCT followed by a single dose of two 40 mg MK-1006 DFC

Baseline Measures

	All Participants
Number of Participants [units: participants]	12
Age, Customized [units: participants]
<35 years	0
Between 35 and 65 years	12
>65 years	0
Gender [units: participants]
Female	5
Male	7

Outcome Measures

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1. Primary:

Area Under the Concentration Versus Time Curve (AUC(0-infinity)) for MK-1006 [ Time Frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 120 hours post-dose ]

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2. Primary:

Maximum Plasma Concentration (Cmax) for MK-1006 [ Time Frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 120 hours post-dose ]

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3. Secondary:

Number of Participants Who Experienced at Least One Adverse Event [ Time Frame: Through 30 days post-dose ]

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4. Secondary:

Number of Participants Who Discontinued Study Medication Due to an Adverse Event [ Time Frame: up to 8 days ]

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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: The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission.

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: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT00979459 History of Changes
Other Study ID Numbers:	MK-1006-010, 2009_663
Study First Received:	September 17, 2009
Results First Received:	July 12, 2012
Last Updated:	September 10, 2012
Health Authority:	United States: Food and Drug Administration

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