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

January 28, 2010
August 14, 2012
May 2010
July 2010   (final data collection date for primary outcome measure)
  • 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 ]
Area under the plasma concentration versus time curve (AUC) [ Time Frame: Up to 120 hours postdose ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01059851 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Pharmacokinetics of MK4305 in Participants With Impaired Renal Function (MK-4305-023)(COMPLETED)
An Open-Label, Single-Dose Study to Investigate the Pharmacokinetics of MK4305 in Patients With Impaired Renal Function

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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Insomnia
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 A
    8 participants with Severe Renal Impairment
    Intervention: Drug: MK-4305
  • Experimental: Part I Panel B
    8 Healthy participants to match participants with Severe Renal Impairment
    Intervention: Drug: MK-4305
  • Experimental: Part II Panel C
    8 participants with Moderate Renal Impairment
    Intervention: Drug: MK-4305
  • Experimental: Part II Panel D
    8 Healthy participants to match participants with Moderate Renal Impairment
    Intervention: Drug: MK-4305
  • Experimental: Part II Panel E
    8 participants with Mild Renal Impairment
    Intervention: Drug: MK-4305
  • Experimental: Part II Panel F
    8 Healthy participants to match participants with Mild Renal Impairment
    Intervention: Drug: MK-4305
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
July 2010
July 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01059851
4305-023, 2010_505
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP