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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01059851
First received: January 28, 2010
Last updated: August 14, 2012
Last verified: August 2012
  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 Sharp & Dohme Corp.:

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 Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
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 April 17, 2014