Pharmacokinetics of MK4305 in Participants With Impaired Renal Function (MK-4305-023)(COMPLETED) - Full Text View

Purpose

This study will investigate whether the plasma concentration-time profile and pharmacokinetics of MK-4305 in participants with impaired renal function are similar to those observed in healthy participants; and will evaluate the safety and tolerability of MK-4305 both in participants with impaired renal function and in healthy participants.

Condition	Intervention	Phase
Insomnia	Drug: MK-4305	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-Label, Single-Dose Study to Investigate the Pharmacokinetics of MK4305 in Patients With Impaired Renal Function

Further study details as provided by Merck:

Primary Outcome Measures:

Area under the plasma concentration versus time curve (AUC) [ Time Frame: Up to 120 hours post dose ] [ Designated as safety issue: No ]
Number of participants with an adverse event [ Time Frame: Up to 14 days after last dose ] [ Designated as safety issue: Yes ]
Number of participants who discontinued treatment due to an adverse event [ Time Frame: Up to 14 days after last dose ] [ Designated as safety issue: Yes ]

Enrollment:	16
Study Start Date:	May 2010
Study Completion Date:	July 2010
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Part I Panel A 8 participants with Severe Renal Impairment	Drug: MK-4305 A single oral dose of 20 mg (administered as 2 x 10-mg) of MK-4305 administered with ~240 mL of water after an 8 hour fast Other Name: MK-4305
Experimental: Part I Panel B 8 Healthy participants to match participants with Severe Renal Impairment	Drug: MK-4305 A single oral dose of 20 mg (administered as 2 x 10-mg) of MK-4305 administered with ~240 mL of water after an 8 hour fast Other Name: MK-4305
Experimental: Part II Panel C 8 participants with Moderate Renal Impairment	Drug: MK-4305 A single oral dose of 20 mg (administered as 2 x 10-mg) of MK-4305 administered with ~240 mL of water after an 8 hour fast Other Name: MK-4305
Experimental: Part II Panel D 8 Healthy participants to match participants with Moderate Renal Impairment	Drug: MK-4305 A single oral dose of 20 mg (administered as 2 x 10-mg) of MK-4305 administered with ~240 mL of water after an 8 hour fast Other Name: MK-4305
Experimental: Part II Panel E 8 participants with Mild Renal Impairment	Drug: MK-4305 A single oral dose of 20 mg (administered as 2 x 10-mg) of MK-4305 administered with ~240 mL of water after an 8 hour fast Other Name: MK-4305
Experimental: Part II Panel F 8 Healthy participants to match participants with Mild Renal Impairment	Drug: MK-4305 A single oral dose of 20 mg (administered as 2 x 10-mg) of MK-4305 administered with ~240 mL of water after an 8 hour fast Other Name: MK-4305

Detailed Description:

If preliminary data from Part I confirms that renal impairment does not alter the pharmacokinetics of MK-4305 to the extent that would require a dosage adjustment, then no further study will be required. If the data does not support this conclusion, then Part II will be conducted.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Impaired Renal Function Participants:

Females of reproductive potential must have a negative pregnancy test and agree to use 2 methods of birth control
Diagnosis of renal insufficiency

Healthy Participants:

Females of reproductive potential must have a negative pregnancy test and agree to use 2 methods of birth control;
In General Good Health

Exclusion Criteria:

Impaired Renal Function Participants:

Is mentally or legally incapacitated
Has rapidly fluctuating renal function or has demonstrated or suspected renal artery stenosis
Has had a kidney transplant
Unstable endocrine, gastrointestinal, cardiovascular, hematological, immunological, respiratory, or genitourinary diseases
History of cancer (Some exceptions apply)
Regular user of barbiturates or sleep aides
Consumes excessive amounts of alcohol (more than 2 drinks/day)
Consumes excessive amounts of caffeinated beverages (more than 6/day)
Has had major surgery within 4 weeks
Has a history of significant multiple and/or severe allergies
Has a history of cataplexy
Participant works a night shift and is not able to avoid night shift work during the study
Current or history of illicit drug abuse
Nursing mothers

Healthy Participants:

Is mentally or legally incapacitated;
Has a history of stroke, chronic seizures, or major neurological disorder
Unstable endocrine, gastrointestinal, cardiovascular, hematological, immunological, respiratory, or genitourinary diseases
History of cancer (Some exceptions apply)
Regular user of barbiturates or sleep aides
Consumes excessive amounts of alcohol (more than 2 drinks/day)
Consumes excessive amounts of caffeinated beverages (more than 6/day)
Has had major surgery within 4 weeks
Has a history of significant multiple and/or severe allergies
Has a history of cataplexy
Participant works a night shift and is not able to avoid night shift work during the study
Current or history of illicit drug abuse
Nursing mothers

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01059851

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT01059851 History of Changes
Other Study ID Numbers:	4305-023, 2010_505
Study First Received:	January 28, 2010
Last Updated:	August 14, 2012
Health Authority:	Russia: Pharmacological Committee, Ministry of Health

Additional relevant MeSH terms:

Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 22, 2013