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Safety Tolerability & Pharmacokinetics of Co-administered Single Doses of OZ439 & Piperaquine to Healthy Subjects

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ClinicalTrials.gov Identifier: NCT01660022
Recruitment Status : Completed
First Posted : August 8, 2012
Results First Posted : January 21, 2015
Last Update Posted : January 21, 2015
Sponsor:
Collaborator:
Cross Research S.A.
Information provided by (Responsible Party):
Medicines for Malaria Venture

Study Description
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Brief Summary:
A Phase I Study to investigate the safety, tolerability & pharmacokinetics of co-administered single doses of OZ439 and Piperaquine to healthy subjects.

Condition or disease Intervention/treatment Phase
Healthy Drug: 100mg OZ439 single oral dose Drug: Placebo Drug: 300 mg OZ439 single oral dose Drug: 160mg Piperaquine single oral dose Drug: 480mg Piperaquine single oral dose Drug: 1440mg Piperaquine single oral dose Drug: 800 mg OZ439 single oral dose Phase 1

Detailed Description:

Placebo-controlled, double-blind, five-cohort, 2-period (per cohort) dose-escalation study.

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Phase I Study to Investigate the Safety, Tolerability & Pharmacokinetics of Co-administered Single Doses of OZ439 and Piperaquine to Healthy Subjects
Study Start Date : September 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013
Arms and Interventions
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Arm Intervention/treatment
Experimental: OZ439 100mg
100mg OZ439 single oral dose
 Drug: 100mg OZ439 single oral dose
100mg OZ439 oral suspension single dose
Other Name: OZ439
Experimental: OZ439 100 mg + PQP 160mg
100mg OZ439 single oral dose + 160mg Piperaquine single oral dose
 Drug: 100mg OZ439 single oral dose
100mg OZ439 oral suspension single dose
Other Name: OZ439

Drug: 160mg Piperaquine single oral dose
160 mg Piperaquine tablet
Other Name: Piperaquine
Experimental: OZ439 100 mg + PQP 480mg
100mg OZ439 single oral dose + 480mg Piperaquine single oral dose
 Drug: 100mg OZ439 single oral dose
100mg OZ439 oral suspension single dose
Other Name: OZ439

Drug: 480mg Piperaquine single oral dose
480 mg Piperaquine tablet
Other Name: Piperaquine
Experimental: OZ439 100 mg + PQP 1440mg
100mg OZ439 single oral dose + 1440mg Piperaquine single oral dose
 Drug: 100mg OZ439 single oral dose
100mg OZ439 oral suspension single dose
Other Name: OZ439

Drug: 1440mg Piperaquine single oral dose
1440 mg Piperaquine tablet
Other Name: Piperaquine
Experimental: OZ439 300mg
300mg OZ439 single oral dose
 Drug: 300 mg OZ439 single oral dose
300mg OZ439 oral suspension single dose
Other Name: OZ439
Experimental: OZ439 300 mg + PQP 1440mg
300mg OZ439 single oral dose + 1440mg Piperaquine single oral dose
 Drug: 300 mg OZ439 single oral dose
300mg OZ439 oral suspension single dose
Other Name: OZ439

Drug: 1440mg Piperaquine single oral dose
1440 mg Piperaquine tablet
Other Name: Piperaquine
Experimental: OZ439 800mg
800mg OZ439 single oral dose
 Drug: 800 mg OZ439 single oral dose
800mg OZ439 oral suspension single dose
Other Name: OZ439
Experimental: OZ439 800 mg + PQP 1440mg
800mg OZ439 single oral dose + 1440mg Piperaquine single oral dose
 Drug: 1440mg Piperaquine single oral dose
1440 mg Piperaquine tablet
Other Name: Piperaquine

Drug: 800 mg OZ439 single oral dose
800mg OZ439 oral suspension single dose
Other Name: OZ439
Placebo Comparator: Placebo
Placebo
 Drug: Placebo
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. OZ439 Cmax [ Time Frame: Up to 168 hours post-dose ]
    OZ439 Maximum concentration level

  2. Piperaquine Cmax [ Time Frame: Up to 1008 hours post-dose (Day 43) ]
    Piperaquine Maximum concentration level

  3. OZ439 AUC(0-168) [ Time Frame: Up to 168 hours post-dose ]
    Area under the plasma concentration versus time curve to 168 hours post-dose.

  4. OZ439 t1/2 [ Time Frame: Up to 168 hours post-dose ]
    OZ439 Elimination half-life

  5. Piperaquine AUC(0-168) [ Time Frame: Up to 1008 hours post-dose (Day 43) ]
    Piperaquine area under the plasma concentration versus time curve to 168 hours post-dose

  6. Piperaquine t1/2 [ Time Frame: Up to 1008 hours post-dose (Day 43) ]
    Piperaquine Elimination half-life (t1/2).


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy males & females, 18-55 years old
  • 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:

  • Any condition that could affect drug absorption, e.g. gastrectomy, diarrhea
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01660022


Locations
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Switzerland
Cross Research S.A.
Mendrisio, Switzerland, CH 6850
Sponsors and Collaborators
Medicines for Malaria Venture
Cross Research S.A.
Investigators
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Principal Investigator: Milko M Radicioni, MD PhD Cross Research S.A.
More Information
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Responsible Party: Medicines for Malaria Venture
ClinicalTrials.gov Identifier: NCT01660022    
Other Study ID Numbers: MMV_OZ439_12_002
First Posted: August 8, 2012    Key Record Dates
Results First Posted: January 21, 2015
Last Update Posted: January 21, 2015
Last Verified: January 2015
Keywords provided by Medicines for Malaria Venture:
Healthy
Volunteers
Additional relevant MeSH terms:
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Piperaquine
Artefenomel
Antimalarials
 Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents