MalariaPhase 1NCT02083406
Bioavailability Study of Oral OZ439 Prototype Formulations Administered With Piperaquine Phosphate (PQP)
A Phase 1 study testing 800mg OZ439 prototype formulation 1, 800mg OZ439 prototype formulation 2 and 800mg OZ439 prototype formulation 3 in people with Malaria, run by Medicines for Malaria Venture at 1 site in United Kingdom.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- 800mg OZ439 prototype formulation 1, 800mg OZ439 prototype formulation 2 and 800mg OZ439 prototype formulation 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2014to Jul 2014
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
- Age 18 to 55 years of age
- Body mass index of 18.0 to 30.0 kg/m2 inclusive. Total body weight >50 kg at screening
- Willing and able to communicate and participate in the whole study
- Must provide written informed consent
- Must agree to use an adequate method of contraception
- Must have liver function tests and haemoglobin within the laboratory reference range at screening and Day -1
- Must have heart trace measurements within the defined healthy limits at screening, Day -1 and pre-dose
Who cannot join
- Male subjects who have currently pregnant partners
- Evidence or history of clinically significant oncological, pulmonary, chronic respiratory, hepatic, cardiovascular, haematological, metabolic, neurological, immunological, nephrological, endocrine or psychiatric disease, or current infection
- Clinically relevant abnormalities in the heart trace including any degree of heart block, including asymptomatic bundle branch block
- 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
- History of symptomatic cardiac arrhythmias or with clinically relevant bradycardia
- Electrolyte disturbances, particularly hypokalemia, hypocalcaemia or hypomagnesaemia.
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- Any condition that could possibly affect drug absorption, such as gastrectomy or diarrhoea
- History of post-antibiotic colitis
- History of any drug or alcohol abuse in the past 2 years prior to screening
- 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.
- Receipt of an investigational drug or participation in another clinical research study within 90 days prior to drug administration.
- Subjects who are study site employees, or immediate family members of a study site or sponsor employee.
- Subjects who have previously been enrolled in this study
- 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:
- amiodarone and hydroxychloroquine (210 days)
- monoclonal antibodies/ immunoglobulins/ other therapeutic proteins and experimental drugs for which the half-life is not known to the investigator (120 days)
- experimental drugs for which half-life is known to the investigator (5 half lives plus 14 days)
- chloroquine, piperaquine phosphate and flunarizine (100 days)
- fluoxetine (75 days)
- 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)
- Positive hepatitis B surface antigen, hepatitis C virus antibody or human immunodeficiency virus results
- Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator
- Positive urine drug screen result at screening or admission to the clinical unit
- 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
- Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
- Presence or history of allergy requiring treatment; hayfever is allowed unless it is active
- Donation or loss of >400 mL of blood within 90 days prior to drug administration
- 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)
- Subjects who do not have suitable veins for multiple blood samples as assessed by the investigator at screening
- Failure to satisfy the investigator of fitness to participate for any other reason
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Quotient Clinical
Nottingham, Nottinghamshire, NG11 6JS
About this study
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
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
- Conditions
- Malaria
- Being tested
- 800mg OZ439 prototype formulation 1, 800mg OZ439 prototype formulation 2, 800mg OZ439 prototype formulation 3, 960mg PQP
- Keywords
- Malaria, Bio-availability
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
800mg OZ439 prototype formulation 1Drug
Also called Treatment A
800mg OZ439 prototype formulation 2Drug
Also called Treatment B
800mg OZ439 prototype formulation 3Drug
Also called Treatment C
960mg PQPDrug
Also called Piperqauine phosphate as powder in bottle
| Study group | Role | What they receive |
|---|---|---|
| Treatment A: OZ439 Prototype 1 | Experimental | 800mg OZ439 prototype formulation 1 and 960mg PQP single doses Receives: Drug: 800mg OZ439 prototype formulation 1; Drug: 960mg PQP |
| Treatment B: OZ439 Prototype 2 | Experimental | 800mg OZ439 prototype formulation 2 and 960mg PQP single doses Receives: Drug: 800mg OZ439 prototype formulation 2; Drug: 960mg PQP |
| Treatment C: OZ439 Prototype 3 | Experimental | 800mg OZ439 prototype formulation 3 and 960mg PQP single doses Receives: Drug: 800mg OZ439 prototype formulation 3; Drug: 960mg PQP |
What is being measured
The primary outcome is the main question the study is designed to answer.
OZ439 AUC(0-168h)
OZ439 Area under the plasma concentration (AUC) versus time curve
Measured: Up to 168 hours post-dose
OZ439 Cmax
OZ439 Maximum observed concentration
Measured: Up to 168 hours post-dose
Secondary outcomes (2)
Piperaquine (PQ) AUC(0-168h)
PQ Area under the plasma concentration versus time curve
Measured: Up to 168h post-dose
PQ Cmax
PQ Maximum observed concentration
Measured: Up to 168h post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicines for Malaria Venture
- Sponsor type
- University, hospital or other
- Collaborators
- Quotient Clinical
- Responsible party
- Sponsor
- Investigators
- Jo Collier, MBChB FFPM, Principal investigator, Quotient Clinical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02083406
- Sponsor's protocol ID
- MMV_OZ439_13_007
- Status last verified
- Mar 2015
- First submitted
- 7 Mar 2014
- Last updated
- 23 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02083406
- Acronym / sponsor ID
- MMV_OZ439_13_007
- Conditions
- Malaria
- Keywords
- Malaria, Bio-availability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Medicines for Malaria VentureUniversity, hospital or other
- Collaborators
- Quotient Clinical
- Study start
- Jul 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 11 Mar 2014 (estimated)
- Results
- Posted 23 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A: OZ439 Prototype 1 | Experimental | Drug: 800mg OZ439 prototype formulation 1, Drug: 960mg PQP800mg OZ439 prototype formulation 1 and 960mg PQP single doses |
| Treatment B: OZ439 Prototype 2 | Experimental | Drug: 800mg OZ439 prototype formulation 2, Drug: 960mg PQP800mg OZ439 prototype formulation 2 and 960mg PQP single doses |
| Treatment C: OZ439 Prototype 3 | Experimental | Drug: 800mg OZ439 prototype formulation 3, Drug: 960mg PQP800mg OZ439 prototype formulation 3 and 960mg PQP single doses |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
- Age 18 to 55 years of age
- Body mass index of 18.0 to 30.0 kg/m2 inclusive. Total body weight >50 kg at screening
- Willing and able to communicate and participate in the whole study
- Must provide written informed consent
Key exclusion criteria (30 listed)
- Male subjects who have currently pregnant partners
- Evidence or history of clinically significant oncological, pulmonary, chronic respiratory, hepatic, cardiovascular, haematological, metabolic, neurological, immunological, nephrological, endocrine or psychiatric disease, or current infection
- Clinically relevant abnormalities in the heart trace including any degree of heart block, including asymptomatic bundle branch block
- 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
- History of symptomatic cardiac arrhythmias or with clinically relevant bradycardia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 800mg OZ439 prototype formulation 1Also: Treatment A | Drug | Treatment A: OZ439 Prototype 1 |
| 800mg OZ439 prototype formulation 2Also: Treatment B | Drug | Treatment B: OZ439 Prototype 2 |
| 800mg OZ439 prototype formulation 3Also: Treatment C | Drug | Treatment C: OZ439 Prototype 3 |
| 960mg PQPAlso: Piperqauine phosphate as powder in bottle | Drug | Treatment A: OZ439 Prototype 1, Treatment B: OZ439 Prototype 2, Treatment C: OZ439 Prototype 3 |
Primary outcome
OZ439 AUC(0-168h)
Time frame: Up to 168 hours post-dose
OZ439 Area under the plasma concentration (AUC) versus time curve
OZ439 Cmax
Time frame: Up to 168 hours post-dose
OZ439 Maximum observed concentration
2 secondary outcomes
Piperaquine (PQ) AUC(0-168h)
Time frame: Up to 168h post-dose
PQ Cmax
Time frame: Up to 168h post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jo Collier, MBChB FFPM principal investigator
Quotient Clinical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 800mg OZ439 prototype formulation 1, 800mg OZ439 prototype formulation 2 and 800mg OZ439 prototype formulation 3 in people with Malaria, run by Medicines for Malaria Venture at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OZ439 AUC(0-168h) (time frame: Up to 168 hours post-dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2015.