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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02453581




Registration number
NCT02453581
Ethics application status
Date submitted
21/05/2015
Date registered
25/05/2015
Date last updated
17/08/2015

Titles & IDs
Public title
Effectiveness of OZ439 Against Early Plasmodium Falciparum Blood Stage Infection in Healthy Volunteers
Scientific title
An Experimental Study To Characterize the Effectiveness of OZ439 Against Early Plasmodium Falciparum Blood Stage Infection In Healthy Volunteers
Secondary ID [1] 0 0
QP12C10
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - OZ439

Experimental: OZ439 100mg - OZ439 100mg Powder for Oral Suspension

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

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


Treatment: Drugs: OZ439
OZ439 Powder for Oral Suspension

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Individual Parasite Reduction Ratio (PRR) - 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.
Timepoint [1] 0 0
48 hours
Primary outcome [2] 0 0
500mg Cohort Mean Parasite Reduction Ratio (PRR) - 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.
Timepoint [2] 0 0
48 hours
Secondary outcome [1] 0 0
OZ439 Cmax - OZ439 Maximum concentration (Cmax)
Timepoint [1] 0 0
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
Secondary outcome [2] 0 0
OZ439 AUC(0-144) - OZ439 Area under the curve to 144 hours
Timepoint [2] 0 0
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

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
45 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Q-Pharm - Herston
Recruitment postcode(s) [1] 0 0
QLD 4006 - Herston

Funding & Sponsors
Primary sponsor type
Other
Name
Medicines for Malaria Venture
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Queensland Institute of Medical Research
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02453581
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
James McCarthy, Pr
Address 0 0
Q-Pharm Pty Limited
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications