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Effectiveness of OZ439 Against Early Plasmodium Falciparum Blood Stage Infection in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02453581
Recruitment Status : Completed
First Posted : May 25, 2015
Results First Posted : July 13, 2015
Last Update Posted : August 17, 2015
Sponsor:
Collaborator:
Queensland Institute of Medical Research
Information provided by (Responsible Party):
Medicines for Malaria Venture

Brief Summary:
A single centre, open, controlled study using Blood Stage Plasmodium falciparum challenge inoculum (BSPC) as a model to assess the effectiveness of three dose levels of the experimental anti-malarial product, OZ439.

Condition or disease Intervention/treatment Phase
Malaria Drug: OZ439 Phase 1

Detailed Description:

This was a single center study using blood stage Plasmodium falciparum challenge inoculum to characterize the effectiveness of OZ439 against early blood stage Plasmodium Falciparum infection.

The study was conducted in three cohorts (n=8) using different doses of OZ439. Dose escalation took place after review of the observed OZ439 safety and pharmacodynamic outcome for the previous cohort by the Safety Review Team.

Single doses of 100 mg, 200 mg and 500 mg were administered orally to participants in Cohort 1, Cohort 2 and Cohort 3 respectively.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Experimental Study To Characterize the Effectiveness of OZ439 Against Early Plasmodium Falciparum Blood Stage Infection In Healthy Volunteers
Study Start Date : September 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Experimental: OZ439 100mg
OZ439 100mg Powder for Oral Suspension
Drug: OZ439
OZ439 Powder for Oral Suspension

Experimental: OZ439 200mg
OZ439 200mg Powder for Oral Suspension
Drug: OZ439
OZ439 Powder for Oral Suspension

Experimental: OZ439 500mg
OZ439 500mg Powder for Oral Suspension
Drug: OZ439
OZ439 Powder for Oral Suspension




Primary Outcome Measures :
  1. Individual Parasite Reduction Ratio (PRR) [ Time Frame: 48 hours ]

    PRR estimates the efficacy of an anti-malarial treatment and is the ratio of the parasite density between admission and 48 hours post-treatment.

    Individual subject PRR and corresponding 95% CI were calculated using the slope and corresponding standard error of mean (SE) of the optimal regression model.


  2. 500mg Cohort Mean Parasite Reduction Ratio (PRR) [ Time Frame: 48 hours ]
    OZ439 500mg individual subject PRR and corresponding 95% CI were used to calculate the OZ439 500mg cohort specific PRR and the corresponding 95% CI: the weighted average slope estimate and corresponding SE were calculated by the inverse-variance method.


Secondary Outcome Measures :
  1. OZ439 Cmax [ Time Frame: Pre-dose, and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose ]
    OZ439 Maximum concentration (Cmax)

  2. OZ439 AUC(0-144) [ Time Frame: Pre-dose, and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose ]
    OZ439 Area under the curve to 144 hours



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Volunteers will be adults (males or non pregnant females), aged between 18 and 45 years who do not live alone (from Day 1 until at least the end of the antimalarial drug treatment).
  • Volunteers must have a BMI within the range 18-30.
  • Volunteers must understand the procedures involved and agree to participate in the study by giving fully informed, written consent.
  • Be contactable and available for the duration of the trial (maximum of 4 weeks).
  • Volunteers must be non-smokers and in good health, as assessed during pre-study medical examination and by review of screening results.
  • Female participants of childbearing potential, should be surgically sterile or using an insertable, injectable, transdermal, or combination oral contraceptive approved by the US FDA or Therapeutic Goods Administration (TGA) combined with a barrier contraceptive through completion of the study and have negative results on a serum or urine pregnancy test done before administration of study medication.
  • Good peripheral venous access.

Exclusion Criteria:

  • History of malaria.
  • Travelled to or lived (2 weeks or more) in a malaria-endemic country during the past 12 months or planned travel to a malaria-endemic country during the course of the study.
  • Has evidence of increased cardiovascular disease risk (defined as greater than 10%, 5 year risk)
  • History of splenectomy.
  • History of a severe allergic reaction, anaphylaxis or convulsions following any vaccination or infusion.
  • Presence of current or suspected serious chronic diseases such as cardiac or autoimmune disease (HIV or other immunodeficiencies), insulin dependent diabetes, progressive neurological disease, severe malnutrition, acute or progressive hepatic disease, acute or progressive renal disease, psoriasis, rheumatoid arthritis, asthma, epilepsy or obsessive compulsive disorder, skin carcinoma excluding non-spreadable skin cancers such as basal cell and squamous cell carcinoma.
  • Known inherited genetic anomaly (known as cytogenetic disorders) e.g., Down's syndrome
  • Volunteers unwilling to defer blood donations to the Australian Red Cross Blood Service (ARCBS) for 6 months.
  • The volunteer has a diagnosis of schizophrenia, severe depression, bi-polar disease, or other severe (disabling) chronic psychiatric diagnosis. Participants who are receiving a single antidepressant drug and are stable for at least 3 months prior to enrollment without decompensating may be allowed to enroll in the study at the investigator's discretion. 10) Presence of acute infectious disease or fever (e.g., sub-lingual temperature 38.5 degrees C) within the five days prior to study product administration.
  • Evidence of acute illness within the four weeks before trial prior to screening.
  • Significant intercurrent disease of any type, in particular liver, renal, cardiac, pulmonary, neurologic, rheumatologic, or autoimmune disease by history, physical examination, and/or laboratory studies including urinalysis.
  • Have ever received a blood transfusion.
  • Evidence of any condition that, in the opinion of the clinical investigator, might interfere with the evaluation of the study objectives or pose excessive risks to participants.

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): NCT02453581


Locations
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Australia, Queensland
Q-Pharm
Herston, Queensland, Australia, QLD 4006
Sponsors and Collaborators
Medicines for Malaria Venture
Queensland Institute of Medical Research
Investigators
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Principal Investigator: James McCarthy, Pr Q-Pharm Pty Limited

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Responsible Party: Medicines for Malaria Venture
ClinicalTrials.gov Identifier: NCT02453581    
Other Study ID Numbers: QP12C10
First Posted: May 25, 2015    Key Record Dates
Results First Posted: July 13, 2015
Last Update Posted: August 17, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases