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

NCT00785551 | Terminated Phase 1

• 1 other identifier: MPC-001-07-1008
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Renal Impairment

Keywords

male; female; pharmacokinetics; normal and impaired renal function

Outcome Measures

Primary Outcomes (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

  72 hours

Secondary Outcomes (1)

• Differences in safety and tolerability of quinine sulfate in healthy subjects versus those with mild and moderate renal impairment

  up to 72 hours

Study Arms (3)

1

EXPERIMENTAL

quinine sulfate 648mg in subjects with normal renal function (CLcr \> 80mL/min)

Drug: quinine sulfate

2

EXPERIMENTAL

quinine sulfate 648mg in subjects with mildly impaired renal function (CLcr \> 50 to 80 mL/min)

Drug: quinine sulfate

3

EXPERIMENTAL

quinine sulfate 648mg in subjects with moderately impaired renal function (CLcr 30 to 50mL/min)

Drug: quinine sulfate

Interventions

quinine sulfate DRUG

2 x 324mg given in one dose to healthy subjects

Also known as: Qualaquin

1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mutual Pharmaceutical Company, Inc.: lead

Study Sites (1)

Cetero Research

Miami Gardens, Florida, 33169, United States

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Quinine

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cinchona Alkaloids; Alkaloids; Heterocyclic Compounds; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Matthew Davis, M.D.

  Mutual Pharmaceutical

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2008
• First Posted: November 5, 2008
• Study Start: November 1, 2007
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: August 1, 2012

Record last verified: 2012-07

Locations

US (1)