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 Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01407276
First received: July 29, 2011
Last updated: April 24, 2012
Last verified: April 2012
  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:


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 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
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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
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 July 23, 2014