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

NCT02453581 | Completed Phase 1 Results

• 1 other identifier: QP12C10
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Malaria

Outcome Measures

Primary Outcomes (2)

• 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.

  48 hours

• 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.

  48 hours

Secondary Outcomes (2)

• OZ439 Cmax

  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 AUC(0-144)

  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

Study Arms (3)

OZ439 100mg

EXPERIMENTAL

OZ439 100mg Powder for Oral Suspension

Drug: OZ439

OZ439 200mg

EXPERIMENTAL

OZ439 200mg Powder for Oral Suspension

Drug: OZ439

OZ439 500mg

EXPERIMENTAL

OZ439 500mg Powder for Oral Suspension

Drug: OZ439

Interventions

OZ439 DRUG

OZ439 Powder for Oral Suspension

OZ439 100mg; OZ439 200mg; OZ439 500mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medicines for Malaria Venture: lead
• Queensland Institute of Medical Research: collaborator

Study Sites (1)

Q-Pharm

Herston, Queensland, QLD 4006, Australia

Location

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Results Point of Contact

• Title: Dr James McCarthy
• Organization: Qeensland Institute of Medical Research

James.McCarthy@qimr.edu.au

+61 7 3845 3796

Study Officials

• James McCarthy, Pr

  Q-Pharm Pty Limited

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2015
• First Posted: May 25, 2015
• Study Start: September 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: August 17, 2015
• Results First Posted: July 13, 2015

Record last verified: 2015-08

Locations

AU (1)