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Comparative Study of Quinine Sulfate in Healthy Patients and in Patients With Renal Impairment

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ClinicalTrials.gov Identifier: NCT00785551
Recruitment Status : Terminated (poor enrollment)
First Posted : November 5, 2008
Last Update Posted : August 1, 2012
Sponsor:
Information provided by (Responsible Party):
Mutual Pharmaceutical Company, Inc.

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'-hydroxyquinine, will be investigated. Safety and tolerability in healthy subjects versus those with mild to moderate renal impairment will be compared, as well.

Condition or disease Intervention/treatment Phase
Healthy Renal Impairment Drug: quinine sulfate Phase 1

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 dosage adjustment in these patients. This study will compare the pharmacokinetics of quinine in patients with normal, mild or moderate renal impairment. Eighteen non-smoking males and female volunteers between 18-65 years of age weighing at least 60 kg with BMI between 18- 40 kg/m2 will be divided into 3 groups of 6 subjects each based on renal function as defined (6 normal, 6 mild impairment, 6 moderate impairment). Subjects will be confined to the study unit during the entire 5 day study period beginning on the evening of Day -3. To confirm renal function classification, creatinine clearance will be measured via 24-hour urine collection from 7am Day -2 until 7am Day -1. On day 1, after a fast of at least 8 hours, each patient will receive a single 648 mg dose of quinine sulfate. Blood and urine samples will be collected at times sufficient to adequately define the pharmacokinetics of quinine and its active metabolite, 3'-hydroxyquinine) in the three study groups. Subjects will be monitored regarding adverse effects throughout study participation.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Single-Dose, Open-Label Comparative Study of the Pharmacokinetics, Safety,and Tolerability of Oral Quinine Sulfate in Healthy Volunteers and Adults With Mild and Moderate Renal Impairment
Study Start Date : November 2007
Primary Completion Date : January 2011
Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
quinine sulfate 648mg in subjects with normal renal function (CLcr > 80mL/min)
Drug: quinine sulfate
2 x 324mg given in one dose to healthy subjects
Other Name: Qualaquin
Experimental: 2
quinine sulfate 648mg in subjects with mildly impaired renal function (CLcr > 50 to 80 mL/min)
Drug: quinine sulfate
2 x 324mg given as one dose to subjects with mild renal impairment
Other Name: Qualaquin
Experimental: 3
quinine sulfate 648mg in subjects with moderately impaired renal function (CLcr 30 to 50mL/min)
Drug: quinine sulfate
2 x 324mg given as one dose to subjects with moderate renal impairment
Other Name: Qualaquin



Primary Outcome Measures :
  1. Alterations pharmacokinetic profile of quinine and 3'-hydroxyquinine in plasma (total and free) and urine following a single 648mg dose of quinine sulfate in healthy subjects with normal renal function versus those with mild and moderate renal impairment [ Time Frame: 72 hours ]

Secondary Outcome Measures :
  1. Differences in safety and tolerability of quinine sulfate in healthy subjects versus those with mild and moderate renal impairment [ Time Frame: up to 72 hours ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00785551


Locations
United States, Florida
Cetero Research
Miami Gardens, Florida, United States, 33169
Sponsors and Collaborators
Mutual Pharmaceutical Company, Inc.
Investigators
Study Chair: Matthew Davis, M.D. Mutual Pharmaceutical

Responsible Party: Mutual Pharmaceutical Company, Inc.
ClinicalTrials.gov Identifier: NCT00785551     History of Changes
Other Study ID Numbers: MPC-001-07-1008
First Posted: November 5, 2008    Key Record Dates
Last Update Posted: August 1, 2012
Last Verified: July 2012

Keywords provided by Mutual Pharmaceutical Company, Inc.:
male
female
pharmacokinetics
normal and impaired renal function

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Quinine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents