Comparative Study of Quinine Sulfate in Healthy Patients and in Patients With Renal Impairment
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| ClinicalTrials.gov Identifier: NCT00785551 |
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Recruitment Status :
Terminated
(poor enrollment)
First Posted : November 5, 2008
Last Update Posted : August 1, 2012
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Sponsor:
Mutual Pharmaceutical Company, Inc.
Information provided by (Responsible Party):
Mutual Pharmaceutical Company, Inc.
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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 |
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 |
| Actual Primary Completion Date : | January 2011 |
| Actual Study Completion Date : | January 2011 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: 1
quinine sulfate 648mg in subjects with normal renal function (CLcr > 80mL/min)
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Drug: quinine sulfate
2 x 324mg given in one dose to healthy subjects
Other Name: Qualaquin |
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Experimental: 2
quinine sulfate 648mg in subjects with mildly impaired renal function (CLcr > 50 to 80 mL/min)
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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)
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Drug: quinine sulfate
2 x 324mg given as one dose to subjects with moderate renal impairment
Other Name: Qualaquin |
Primary Outcome Measures :
- 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 :
- 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, Older 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 |
| 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.:
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male female pharmacokinetics normal and impaired renal function |
Additional relevant MeSH terms:
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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 |