A Phase 1 Study To Estimate The Relative Bioavailability Of Co-Administered Formulations Of Azithromycin Microsphere And Chloroquine Test Formulation Compared With Co-Administered Immediate Release Individual Azithromycin And Chloroquine Tablets In Healthy Adult Subjects (AZCQ)

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01100060
First received: March 26, 2010
Last updated: August 24, 2010
Last verified: August 2010
  Purpose

Estimate the relative bioavailability of co-administered azithromycin microsphere (2000 mg) and the chloroquine (620 mg CQ base) test formulation compared to co-administered immediate release individual tablets of azithromycin (2000 mg) and chloroquine (600 mg CQ base) in healthy adult subjects.


Condition Intervention Phase
Malaria Prophylaxis
Drug: azithromycin (AZ) microsphere
Drug: test chloroquine (CQ) formulation
Drug: azithromycin (AZ)
Drug: chloroquine (CQ)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Phase 1, Open-Label, Randomized, Single Dose, Parallel Design Study To Estimate The Relative Bioavailability Of Co Administered Formulations Of Azithromycin Microsphere (AZ) And Chloroquine Test Formulation (CQ) Compared With Co Administered Immediate Release Individual AZ And CQ Tablets In Healthy Adult Subjects

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • AUClast of azithromycin and chloroquine [ Time Frame: Through Day 5 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tmax and Cmax of azithromycin and chloroquine. [ Time Frame: Through Day 5 ] [ Designated as safety issue: No ]
  • AUClast, Tmax, and Cmax of desethylchloroquine. [ Time Frame: Through Day 5 ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: April 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Co-administer the test chloroquine (CQ) formulation (620 mg CQ base) plus microsphere azithromycin (AZ) (2000 mg) on Day 1.
Drug: azithromycin (AZ) microsphere
AZ microsphere (2000 mg) single dose on Day 1.
Other Name: Zmax
Drug: test chloroquine (CQ) formulation
Test CQ formulation, 620 mg CQ base, single dose on Day 1.
Active Comparator: Group 2
Co-administer the individual tablets of CQ 2 x 500 mg (600 mg CQ base) tablets plus AZ IR 4 x 500 mg tablets on Day 1.
Drug: azithromycin (AZ)
AZ IR 4 x 500 mg tablets, single dose on Day 1.
Other Name: Zithromax
Drug: chloroquine (CQ)
CQ 2 x 500 mg (600 mg CQ base) tablets, single dose on Day 1
Other Name: Aralen

Detailed Description:

Evaluate the relative bioavailability, assessment of the safety and tolerability of azithromycin microsphere and the chloroquine test formulation compared to immediate release individual tablets.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
  • An informed consent document signed and dated by the subject or a legally acceptable representative.
  • Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • History of febrile illness within 5 days prior to first dose.
  • Treatment with azithromycin within the past 30 days or with chloroquine within the past 45 days.
  • Known immediate family history of prolonged QT Syndrome, serious ventricular arrhythmia, or sudden cardiac death. "Immediate" is considered "first degree".
  • Known allergy to macrolide antibiotics (eg, erythromycin, clarithromycin, azithromycin) or chloroquine (or other 4 aminoquinolines) or severe allergic reaction to any drug in the past (eg, difficulty breathing, anaphylaxis).
  • History of intolerance to azithromycin or chloroquine.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01100060

Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01100060     History of Changes
Other Study ID Numbers: A0661195
Study First Received: March 26, 2010
Last Updated: August 24, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Azithromycin
chloroquine
microsphere
pharmacokinetics
bioavailability

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Chloroquine
Chloroquine diphosphate
Azithromycin
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
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
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 22, 2014