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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Asan Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01366235
First received: May 31, 2011
Last updated: June 2, 2011
Last verified: May 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Healthy Volunteers
 Drug: chloroquine phosphate 1000 mg
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Clinical Trial for Evaluation of Ethnic Differences in Pharmacokinetics of Chloroquine, an Anti-malarial Drug

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • pharmacokinetic evaluation [ Time Frame: within 30 days ] [ Designated as safety issue: Yes ]
    maximum of concentration(Cmax)


Secondary Outcome Measures:
  • pharmacokinetic evaluations [ Time Frame: within 30 days ] [ Designated as safety issue: Yes ]
    Area under the time-concentration curve(AUC)


Estimated Enrollment: 24
Study Start Date: May 2011
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01366235

Locations
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Kyun-Seop Bae, M.D., Ph.D.     82-2-3010-4622        
Sponsors and Collaborators
Asan Medical Center
  More Information

Additional Information:
Clinical Research Center, Asan Medical Center  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT01366235     History of Changes
Other Study ID Numbers: 2011-0214
Study First Received: May 31, 2011
Last Updated: June 2, 2011
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Antimalarials
Chloroquine
Chloroquine diphosphate
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Amebicides
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
 Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Filaricides
Antinematodal Agents
Anthelmintics
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2013