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A Study of MK-3102 in Participants With Impaired Renal Function (MK-3102-009)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01407276
First received: July 29, 2011
Last updated: April 24, 2012
Last verified: April 2012
History of Changes
  Purpose

This is a 2-part study in participants with renal impairment and matched healthy participants to investigate the effect of impaired renal function on the plasma and urine levels of MK-3102 after taking a single 3 mg dose by mouth.


Condition Intervention Phase
Chronic Renal Insufficiency
Type 2 Diabetes Mellitus
 Drug: MK-3102
 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, Two-Part, Single-Dose Study to Investigate the Pharmacokinetics, Safety and Tolerability of MK-3102 in Patients With Impaired Renal Function

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Area under the plasma concentration versus time curve (AUC) [ Time Frame: Up to 336 hours postdose ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: August 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part 1: Mild Renal Impairment (Panel A) Drug: MK-3102
Single oral dose of 3 mg (3 x 1-mg capsules)
Experimental: Part 1: Control to Match Panel A (Panel B) Drug: MK-3102
Single oral dose of 3 mg (3 x 1-mg capsules)
Experimental: Part 1: Moderate Renal Impairment (Panel C) Drug: MK-3102
Single oral dose of 3 mg (3 x 1-mg capsules)
Experimental: Part 1: Control to Match Panel C (Panel D) Drug: MK-3102
Single oral dose of 3 mg (3 x 1-mg capsules)
Experimental: Part 1: Severe Renal Impairment (Panel E) Drug: MK-3102
Single oral dose of 3 mg (3 x 1-mg capsules)
Experimental: Part 1: Control to Match Panel E (Panel F) Drug: MK-3102
Single oral dose of 3 mg (3 x 1-mg capsules)
Experimental: Part 2: End-stage Renal Disease needing hemodialysis (Panel G) Drug: MK-3102
Single oral dose of 3 mg (3 x 1-mg capsules)
Experimental: Part 2: Control to Match Panel G (Panel H) Drug: MK-3102
Single oral dose of 3 mg (3 x 1-mg capsules)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Impaired Renal Function Subjects:

  • Females of reproductive potential must have a negative pregnancy test and agree to use 2 methods of birth control
  • Diagnosis of renal insufficiency based on estimated glomerular filtration rate (eGFR) calculated using the Modification of Diet in Renal Disease (MDRD) equation

Healthy Subjects:

  • 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 Subjects:

  • Is mentally or legally incapacitated
  • Has rapidly fluctuating renal function or has demonstrated or suspected renal artery stenosis Endocrine, gastrointestinal, cardiovascular, hematological, immunological, respiratory, or genitourinary diseases
  • History of stroke, chronic seizures or major neurological disease
  • Uncontrolled Type 2 diabetes or history of Type 1 diabetes or ketoacidosis
  • 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 or has lost or donated 1 unit of blood within 4 weeks
  • Has a history of significant multiple and/or severe allergies
  • Current or history of illicit drug abuse
  • Nursing mothers

Healthy Subjects:

  • Is mentally or legally incapacitated;
  • Has a history of stroke, chronic seizures, or major neurological disorder
  • Renal impairment
  • Unstable endocrine, gastrointestinal, cardiovascular, hematological, immunological, respiratory, or genitourinary diseases
  • Hypoglycemia, glucose intolerance, Type 1 or Type 2 diabetes, or ketoacidosis
  • 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 or has lost or donated 1 unit of blood within 4 weeks
  • Has a history of significant multiple and/or severe allergies
  • Current or history of illicit drug abuse
  • Nursing mothers
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01407276     History of Changes
Other Study ID Numbers: MK-3102-009
Study First Received: July 29, 2011
Last Updated: April 24, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
 Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on June 18, 2013