Clinical Trial for Evaluation of Ethnic Differences in Pharmacokinetics of Chloroquine, an Anti-malarial Drug

Chloroquine is an anti-malaria agent. This study is designed to evaluate inter-ethnic differences of therapeutic effect of chloroquine and search the cause of these ethnic differences. For this purpose, chloroquine will be administered to four ethic groups of Korean, Caucasian, African and Southeast Asian and chloroquine concentration in blood will be measured. The result of this study will be helpful in finding more adequate dosing regimen of chloroquine in patients with malaria.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: chloroquine phosphate 1000 mg

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• aged 20 - 50 male subjects (6 Koreans, 6 Caucasians, 6 Africans and 6 Southeast Asians)
• Subjects with body weight ≥ 45 kg and within ±20% of the ideal body weight : Ideal body weight = (height [cm] - 100)x0.9.

Exclusion Criteria:

• Subjects who have drunken habitually (exceeding 21 units/week, 1 unit = 10 g of pure alcohol) or who are unable to abstain from drinking during the study period from 2 days prior to the first administration of investigational product and during this study.
• Subjects deemed ineligible by investigator based on other reasons, including abnormal laboratory values or diseases.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Southeast Asians	Drug: chloroquine phosphate 1000 mg; 1000 mg, 1day
Experimental: Korean	Drug: chloroquine phosphate 1000 mg; 1000 mg, 1day
Experimental: Caucasians	Drug: chloroquine phosphate 1000 mg; 1000 mg, 1day
Experimental: Africans	Drug: chloroquine phosphate 1000 mg; 1000 mg, 1day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pharmacokinetic evaluation	maximum of concentration(Cmax)	within 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pharmacokinetic evaluations	Area under the time-concentration curve(AUC)	within 30 days

Collaborators and Investigators

• Sponsor: Asan Medical Center

Publications and helpful links

Helpful Links

• Clinical Research Center, Asan Medical Center

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: May 31, 2011
• First Submitted That Met QC Criteria: June 2, 2011
• First Posted (Estimate): June 6, 2011

Study Record Updates

• Last Update Posted (Estimate): January 26, 2015
• Last Update Submitted That Met QC Criteria: January 23, 2015
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anti-Infective Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Amebicides; Filaricides; Antinematodal Agents; Anthelmintics; Chloroquine; Chloroquine diphosphate
• Other Study ID Numbers: 2011-0214