Safety Tolerability & Pharmacokinetics of Co-administered Single Doses of OZ439 & Piperaquine to Healthy Subjects
NCT ID: NCT01660022
Last Updated: 2015-01-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
59 participants
INTERVENTIONAL
2012-09-30
2013-05-31
Brief Summary
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Detailed Description
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For each subject, the study included a screening evaluation (within 21 days of the 1st dose), dosing on 2 separate occasions (Period 1 and Period 2) and a follow-up visit (6 weeks following the final dose).
Within each cohort, subjects were randomised into two sequences to receive OZ439 in Period 1 and OZ439 plus piperaquine in Period 2 (sequence 1, 8 subjects) or OZ439-matching placebo in Period 1 and OZ439/piperaquine matching placebos in Period 2 (sequence 2, 4 subjects).
Safety and tolerability were evaluated: Physical examination, ECG assessments including a full baseline matched profile of ECG tracings, vital signs, laboratory evaluations, in particular liver function tests and adverse events.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
QUADRUPLE
Study Groups
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OZ439 100mg
100mg OZ439 single oral dose
100mg OZ439 single oral dose
100mg OZ439 oral suspension single dose
OZ439 100 mg + PQP 160mg
100mg OZ439 single oral dose + 160mg Piperaquine single oral dose
100mg OZ439 single oral dose
100mg OZ439 oral suspension single dose
160mg Piperaquine single oral dose
160 mg Piperaquine tablet
OZ439 100 mg + PQP 480mg
100mg OZ439 single oral dose + 480mg Piperaquine single oral dose
100mg OZ439 single oral dose
100mg OZ439 oral suspension single dose
480mg Piperaquine single oral dose
480 mg Piperaquine tablet
OZ439 100 mg + PQP 1440mg
100mg OZ439 single oral dose + 1440mg Piperaquine single oral dose
100mg OZ439 single oral dose
100mg OZ439 oral suspension single dose
1440mg Piperaquine single oral dose
1440 mg Piperaquine tablet
OZ439 300mg
300mg OZ439 single oral dose
300 mg OZ439 single oral dose
300mg OZ439 oral suspension single dose
OZ439 300 mg + PQP 1440mg
300mg OZ439 single oral dose + 1440mg Piperaquine single oral dose
300 mg OZ439 single oral dose
300mg OZ439 oral suspension single dose
1440mg Piperaquine single oral dose
1440 mg Piperaquine tablet
OZ439 800mg
800mg OZ439 single oral dose
800 mg OZ439 single oral dose
800mg OZ439 oral suspension single dose
OZ439 800 mg + PQP 1440mg
800mg OZ439 single oral dose + 1440mg Piperaquine single oral dose
1440mg Piperaquine single oral dose
1440 mg Piperaquine tablet
800 mg OZ439 single oral dose
800mg OZ439 oral suspension single dose
Placebo
Placebo
Placebo
Placebo
Interventions
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100mg OZ439 single oral dose
100mg OZ439 oral suspension single dose
Placebo
Placebo
300 mg OZ439 single oral dose
300mg OZ439 oral suspension single dose
160mg Piperaquine single oral dose
160 mg Piperaquine tablet
480mg Piperaquine single oral dose
480 mg Piperaquine tablet
1440mg Piperaquine single oral dose
1440 mg Piperaquine tablet
800 mg OZ439 single oral dose
800mg OZ439 oral suspension single dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BMI 18 to 30kg/m2; total body weight \>50kg
* Healthy, determined by pre-study medical history, physical examination vital signs, 12 Lead ECG
* Females of non-childbearing potential.
* Males must agree to use a double barrier method of contraception
* Lab tests at screening within the reference ranges
Exclusion Criteria
* Clinically relevant abnormalities in ECG
* Family history of sudden death or of congenital prolongation of QTc interval - History of symptomatic cardiac arrhythmias or with clinically relevant bradycardia
* Electrolyte disturbances
* History of drug or alcohol abuse, tobacco users
* Participation in evaluation of any drug for 3 months before the study
* Administration of ANY systemic medication/herbal product within 14 days of first dose of study drug.
* unaccustomed strenuous exercise within 7 days of any study visit
* Alcohol consumption within 24 hours of any study visit
* Consumption of any fruit juice or food containing grapefruit within 7 days
* Positive test for HIV-1, HBsAg or HCV
* Positive urine drug screen at Screening or admission
* Severe allergies/multiple drug allergies
* Volunteers who have donated blood or experienced significant blood loss within 90 days of screening
* Hemoglobin below lower limit of the reference range
* Clinically relevant abnormal lab values indicative of physical illness
18 Years
55 Years
ALL
Yes
Sponsors
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Cross Research S.A.
INDUSTRY
Medicines for Malaria Venture
OTHER
Responsible Party
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Principal Investigators
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Milko M Radicioni, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Cross Research S.A.
Locations
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Cross Research S.A.
Mendrisio, , Switzerland
Countries
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Other Identifiers
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MMV_OZ439_12_002
Identifier Type: -
Identifier Source: org_study_id
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