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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014