Status:
TERMINATED
Comparative Study of Quinine Sulfate in Healthy Patients and in Patients With Renal Impairment
Lead Sponsor:
Mutual Pharmaceutical Company, Inc.
Conditions:
Healthy
Renal Impairment
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The effects of mild or moderate renal impairment (creatinine clearance 30 to 50 ml/min or \>50 to 80 ml/min, respectively) on the pharmacokinetic profile of quinine and its active metabolite, 3'-hydro...
Detailed Description
Since many of the adverse events associated with quinine are dose-related, it is important to consider how varying degrees of renal dysfunction alter quinine pharmacokinetics possibly warranting dosag...
Eligibility Criteria
Inclusion
- All subjects - non-smoking, male and female volunteers 18-65 years of age weighing at least 60kg with BMI between 18- 40kg/m2. Females of childbearing potential sexually inactive or using acceptable birth control method for 14 days prior to through 3 days following dosing or postmenopausal with amenorrhea for at least 2 years, adequate venous access
- Healthy subjects - medically healthy based on designated clinical criteria including CLcr\>80 ml/min and hemoglobin 11g/dL or greater
- Renally-impaired subjects - medically acceptable based on designated clinical criteria including good glucose control if diabetic, CLcr 30 to 80 ml/min, hemoglobin 10 g/dL or greater, anticipation that medications necessary for treatment of renal disease and/or other coexisting disease will remain stable for 14 days prior to and throughout the study period
Exclusion
- Pregnant or lactating; history of presence of significant cardiovascular, pulmonary, hepatic, hematologic, gastrointestinal, endocrine, immunologic, musculoskeletal, dermatologic, neurologic, or psychiatric disease; positive at screening for HIV, HbsAg, or HCV; QTc \>440 msec (male) or 450 msec (female) or PR \>200 msec, sitting BP \< 90/55, sitting radial pulse \< 45 bpm at screening or baseline; history of G6PD deficiency, myasthenia gravis, or optic neuritis; hypersensitivity or idiosyncratic reaction to mefloquine or quinidine; recent/ongoing use of drugs or substances known to inhibit or induce CYP P450 enzymes and/or P-glycoprotein or quinine; hx of alcoholism or drug abuse within previous 2 years; donation of blood or plasma within 56 days prior to dosing; receipt of study medication in another clinical trial within 30 days of dosing
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00785551
Start Date
November 1 2007
End Date
January 1 2011
Last Update
August 1 2012
Active Locations (1)
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1
Cetero Research
Miami Gardens, Florida, United States, 33169