AZCQ: 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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT01100060

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Malaria Prophylaxis	Drug: azithromycin (AZ) microsphere Drug: test chloroquine (CQ) formulation Drug: azithromycin (AZ) Drug: chloroquine (CQ)	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Apr 1, 2010

Actual Primary Completion Date :

Jun 1, 2010

Actual Study Completion Date :

Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: Zithromax Drug: chloroquine (CQ) CQ 2 x 500 mg (600 mg CQ base) tablets, single dose on Day 1 Other Names: Aralen

Arm

Intervention/Treatment

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 Names:

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 Names:

Zithromax

Drug: chloroquine (CQ)

CQ 2 x 500 mg (600 mg CQ base) tablets, single dose on Day 1

Other Names:

Aralen

Outcome Measures

Primary Outcome Measures

AUClast of azithromycin and chloroquine [Through Day 5]

Secondary Outcome Measures

Tmax and Cmax of azithromycin and chloroquine. [Through Day 5]
AUClast, Tmax, and Cmax of desethylchloroquine. [Through Day 5]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.