Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Bioavailability Study of Oral OZ439 Prototype Formulations Administered With Piperaquine Phosphate (PQP)

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: NCT02083406
Recruitment Status : Completed
First Posted : March 11, 2014
Results First Posted : March 23, 2015
Last Update Posted : March 23, 2015
Sponsor:
Collaborator:
Quotient Clinical
Information provided by (Responsible Party):
Medicines for Malaria Venture

Brief Summary:
A single dose study to investigate how different formulations of OZ439 co-administered with PQP tablest are processed by the body when taken without food

Condition or disease Intervention/treatment Phase
Malaria Drug: 800mg OZ439 prototype formulation 1 Drug: 800mg OZ439 prototype formulation 2 Drug: 800mg OZ439 prototype formulation 3 Drug: 960mg PQP Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label Study to Investigate the Pharmacokinetics of Prototype Formulations of OZ439 Administered With Piperaquine Phosphate in the Fasted State to Healthy Subjects
Study Start Date : July 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Experimental: Treatment A: OZ439 Prototype 1
800mg OZ439 prototype formulation 1 and 960mg PQP single doses
Drug: 800mg OZ439 prototype formulation 1
Other Name: Treatment A

Drug: 960mg PQP
Other Name: Piperqauine phosphate as powder in bottle

Experimental: Treatment B: OZ439 Prototype 2
800mg OZ439 prototype formulation 2 and 960mg PQP single doses
Drug: 800mg OZ439 prototype formulation 2
Other Name: Treatment B

Drug: 960mg PQP
Other Name: Piperqauine phosphate as powder in bottle

Experimental: Treatment C: OZ439 Prototype 3
800mg OZ439 prototype formulation 3 and 960mg PQP single doses
Drug: 800mg OZ439 prototype formulation 3
Other Name: Treatment C

Drug: 960mg PQP
Other Name: Piperqauine phosphate as powder in bottle




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

  2. OZ439 Cmax [ Time Frame: Up to 168 hours post-dose ]
    OZ439 Maximum observed concentration


Secondary Outcome Measures :
  1. Piperaquine (PQ) AUC(0-168h) [ Time Frame: Up to 168h post-dose ]
    PQ Area under the plasma concentration versus time curve

  2. PQ Cmax [ Time Frame: Up to 168h post-dose ]
    PQ Maximum observed concentration



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  1. Healthy males, or healthy females of non-childbearing potential ie surgically sterilised or post-menopausal (amenorrhoea for at least 1 year and confirmed by a follicle stimulating hormone result of ≥25 IU/mL
  2. Age 18 to 55 years of age
  3. Body mass index of 18.0 to 30.0 kg/m2 inclusive. Total body weight >50 kg at screening
  4. Willing and able to communicate and participate in the whole study
  5. Must provide written informed consent
  6. Must agree to use an adequate method of contraception
  7. Must have liver function tests and haemoglobin within the laboratory reference range at screening and Day -1
  8. Must have heart trace measurements within the defined healthy limits at screening, Day -1 and pre-dose

Exclusion Criteria:

  1. Male subjects who have currently pregnant partners
  2. Evidence or history of clinically significant oncological, pulmonary, chronic respiratory, hepatic, cardiovascular, haematological, metabolic, neurological, immunological, nephrological, endocrine or psychiatric disease, or current infection
  3. Clinically relevant abnormalities in the heart trace including any degree of heart block, including asymptomatic bundle branch block
  4. Family history of sudden death or of congenital prolongation of the QTc interval or known congenital prolongation of the QTc interval or any clinical condition known to prolong the QTc interval
  5. History of symptomatic cardiac arrhythmias or with clinically relevant bradycardia
  6. Electrolyte disturbances, particularly hypokalemia, hypocalcaemia or hypomagnesaemia.
  7. Any condition that could possibly affect drug absorption, such as gastrectomy or diarrhoea
  8. History of post-antibiotic colitis
  9. History of any drug or alcohol abuse in the past 2 years prior to screening
  10. Subjects who have a breath carbon monoxide reading of greater than 10 ppm at screening will be excluded. Subjects who are tobacco users (including smokers and users of snuff, chewing tobacco and other nicotine or nicotine-containing products) must have stopped use within 90 days before screening.
  11. Receipt of an investigational drug or participation in another clinical research study within 90 days prior to drug administration.
  12. Subjects who are study site employees, or immediate family members of a study site or sponsor employee.
  13. Subjects who have previously been enrolled in this study
  14. Use of ANY prescription or non-prescription medications, vitamins, herbal supplements or dietary supplements, including protein supplements, within 14 days prior to the first dose of study drug and throughout the study, unless prior approval is granted by both the investigator and the sponsor. An exception will be made for intermittent use of paracetamol and hormone replacement therapy. Paracetamol at doses of, at most, 2 g per day or no more than 3 consecutive days or 6 non consecutive days, are allowed until 24 hours before dosing with study drug. Longer exclusion periods apply for:

    1. amiodarone and hydroxychloroquine (210 days)
    2. monoclonal antibodies/ immunoglobulins/ other therapeutic proteins and experimental drugs for which the half-life is not known to the investigator (120 days)
    3. experimental drugs for which half-life is known to the investigator (5 half lives plus 14 days)
    4. chloroquine, piperaquine phosphate and flunarizine (100 days)
    5. fluoxetine (75 days)
    6. benzodiazepines (for midazolam, lorazepam and triazolam, the exclusion period is 14 days), chlorpromazine, mephenytoin, nortryptyline, phenobarbital, primidone, phenprocoumone and cytochrome P450 3A4 inducers not already mentioned, including but not restricted to, rifampin, carbamazepine, oxcarbazepine, phenytoin and St John's Wort (35 days)
  15. Positive hepatitis B surface antigen, hepatitis C virus antibody or human immunodeficiency virus results
  16. Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator
  17. Positive urine drug screen result at screening or admission to the clinical unit
  18. History of intolerance or hypersensitivity to piperaquine or any 4-aminoquinolone, or ascertained or presumptive hypersensitivity to the active principle and/or formulation ingredients; history of anaphylaxis to drugs or allergic reactions in general, that the investigator considers may affect the outcome of the study
  19. Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
  20. Presence or history of allergy requiring treatment; hayfever is allowed unless it is active
  21. Donation or loss of >400 mL of blood within 90 days prior to drug administration
  22. Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
  23. Subjects who do not have suitable veins for multiple blood samples as assessed by the investigator at screening
  24. Failure to satisfy the investigator of fitness to participate for any other reason

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): NCT02083406


Locations
Layout table for location information
United Kingdom
Quotient Clinical
Nottingham, Nottinghamshire, United Kingdom, NG11 6JS
Sponsors and Collaborators
Medicines for Malaria Venture
Quotient Clinical
Investigators
Layout table for investigator information
Principal Investigator: Jo Collier, MBChB FFPM Quotient Clinical
Layout table for additonal information
Responsible Party: Medicines for Malaria Venture
ClinicalTrials.gov Identifier: NCT02083406    
Other Study ID Numbers: MMV_OZ439_13_007
First Posted: March 11, 2014    Key Record Dates
Results First Posted: March 23, 2015
Last Update Posted: March 23, 2015
Last Verified: March 2015
Keywords provided by Medicines for Malaria Venture:
Malaria
Bio-availability
Additional relevant MeSH terms:
Layout table for MeSH terms
Malaria
Protozoan Infections
Parasitic Diseases
Infections
Vector Borne Diseases
Artefenomel
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents