MalariaPhase 1NCT02387580

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

A Phase 1 study testing OZ439 + TPGS, OZ439 Prototype 1 and OZ439 Prototype 3 in people with Malaria, run by Medicines for Malaria Venture at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is a single-centre, 2-part, randomised, single-dose parallel group study in healthy male subjects and female subjects of non-childbearing potential. 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?: OZ439 + TPGS, OZ439 Prototype 1 and OZ439 Prototype 3
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 siteUnited Kingdom
Study dates: Apr 2015to Jun 2015
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
Body mass index of 18.0 to 30.0 kg/m2 inclusive. Total body weight >50 kg at screening.
Must agree to use an adequate method of contraception.
Normal laboratory tests as judged by the Investigator.
Must have QTcF ≤450 ms, QTcB ≤450 ms for male subjects, QTcF ≤470 ms, QTcB ≤470 ms for female subjects and PR interval ≤200 ms for screening and pre-dose ECG measurements.

Who cannot join

Male subjects who have currently pregnant partners or who have partners planning to be pregnant.
Evidence or history of clinically significant disease, or current infection.3.
Clinically relevant abnormalities in the ECG.
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, heart rate ≤39 bpm.
Electrolyte disturbances, particularly hypokalaemia, hypocalcaemia or hypomagnesaemia.

Show all 15Show fewer

History of any drug or alcohol abuse in the past 2 years prior to screening.
Receipt of an investigational drug or participation in another clinical research study within 90 days prior to drug administration.
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.
Positive hepatitis B surface antigen, hepatitis C virus antibody or human immunodeficiency virus results.
Clinically significant abnormal biochemistry, haematology or urinalysis.
Positive urine drug screen result.
History of intolerance or hypersensitivity to PQP or any 4-aminoquinoline, 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.
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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Quotient Clinical
Nottingham, Nottinghamshire, NG11 6JS

Other trials in United Kingdom

About this study

Official title: A Phase I Bioavailability Study of Selected Oral Prototype Granule Formulations of OZ439 in Healthy Subjects, to Evaluate the Pharmacokinetics of OZ439 When Co-Administered With Piperaquine Phosphate Tablets in the Fasted State

This is a single-centre, 2-part, randomised, single-dose parallel group study in healthy male subjects and female subjects of non-childbearing potential.

Read the detailed description

Parts 1 and 2 will be randomised with 8 subjects receiving each regimen:

Part 1:

Regimen A: Reference: 800 mg OZ439 + α-Tocopherol polyethylene glycol 1000 succinate (TPGS) granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
Regimen B: Prototype 1: 800 mg OZ439 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
Regimen C: Prototype 3: 800 mg OZ439 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets

There will be an interim decision after Part 1 to determine the formulation prototypes and the oral suspension volume to be administered in Part 2.

Part 2

Regimen D: Reference: 800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
Regimen E: Prototype 1 or 3: 800 mg OZ439 granules (oral suspension and rinse volume to be determined) and 960 mg (3 × 320 mg) PQP tablets
Regimen F: Prototype 1 or 3: 800 mg OZ439 granules (oral suspension and rinse volume to be determined) and 960 mg (3 × 320 mg) PQP tablets

Conditions: Malaria
Being tested: OZ439 + TPGS, OZ439 Prototype 1, OZ439 Prototype 3, PQP
Keywords: Malaria, Bioavailability, Formulation
Medical subject headings: Malaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OZ439 + TPGSDrug
Also called 800 mg OZ439 + TPGS Reference Treatment
OZ439 Prototype 1Drug
Also called OZ439 Granules Prototype 1 Granules Formulation
OZ439 Prototype 3Drug
Also called OZ439 Granules Prototype 3 Granules Formulation
PQPDrug
Also called PQP 960 mg tablets

Study groups in NCT02387580
Study group	Role	What they receive
Regimen A: OZ439 + TPGS and PQP	Active comparator	800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets Receives: Drug: OZ439 + TPGS; Drug: PQP
Regimen B: OZ439 Prototype 1 and PQP - 110mL	Experimental	800 mg OZ439 Prototype 1 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets Receives: Drug: OZ439 Prototype 1; Drug: PQP
Regimen C: OZ439 Prototype 3 and PQP - 110mL	Experimental	800 mg OZ439 Prototype 3 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets Receives: Drug: OZ439 Prototype 3; Drug: PQP
Regimen D: OZ439 + TPGS and PQP	Active comparator	800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets Receives: Drug: OZ439 + TPGS; Drug: PQP
Regimen E: OZ439 Prototype 1 or 3 and PQP - XmL	Experimental	800 mg OZ439 Prototype 1 or 3 granules (oral suspension and rinse volume to be determined) and 960 mg (3 × 320 mg) PQP tablets Receives: Drug: OZ439 Prototype 1; Drug: PQP
Regimen F: OZ439 Prototype 1 or 3 and PQP - XmL	Experimental	800 mg OZ439 Prototype 1 or 3 granules (oral suspension and rinse volume to be determined) and 960 mg (3 × 320 mg) PQP tablets Receives: Drug: OZ439 Prototype 3; Drug: PQP

What is being measured

The primary outcome is the main question the study is designed to answer.

OZ439 Cmax
OZ439 Maximum observed concentration
Measured: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours post-dose
OZ439 AUC(0-168 h)
OZ439 Area under the plasma concentration (AUC) versus time curve
Measured: pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours post-dose
Piperaquine Cmax
Piperaquine Maximum observed concentration
Measured: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours and Day36 post-dose
Piperaquine AUC(0-168 h)
PQP Area under the plasma concentration versus time curve
Measured: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours and Day36 post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2015Jun 2015

First posted13 Mar 2015 (estimated)
Study startApr 2015
Primary completionJun 2015
Study completionJun 2015

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: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02387580
Sponsor's protocol ID: MMV_OZ439_15_001
Status last verified: Jan 2016
First submitted: 5 Mar 2015
Last updated: 8 Feb 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
RecruitingObservational study
Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali
Malaria
RecruitingPhase 1
Safety, Tolerability and Efficacy of PfSPZ-LARC2 Vaccine Against CHMI in Malaria-Naïve Adults
Malaria Falciparum
Not yet recruiting
Three-arm Cluster Randomised Control Trial Evaluation of Guardian Spatial Emanator as a Complimentary Vector Control Tool in Papua New Guinea
Malaria

All Malaria trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Bioavailability Study of Selected Oral Prototype Granule Formulations of OZ439 in Healthy Subjects, to Evaluate the Pharmacokinetics of OZ439 When Co-Administered With Piperaquine Phosphate Tablets in the Fasted State
ClinicalTrials.gov ID: NCT02387580
Acronym / sponsor ID: MMV_OZ439_15_001
Conditions: Malaria
Keywords: Malaria, Bioavailability, Formulation
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Medicines for Malaria VentureUniversity, hospital or other
Collaborators: Quotient Clinical
Study start: Apr 2015
Primary completion: Jun 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 13 Mar 2015 (estimated)
Results: Posted 14 Jan 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a single-centre, 2-part, randomised, single-dose parallel group study in healthy male subjects and female subjects of non-childbearing potential.

Detailed description

Parts 1 and 2 will be randomised with 8 subjects receiving each regimen:

Part 1:

Regimen A: Reference: 800 mg OZ439 + α-Tocopherol polyethylene glycol 1000 succinate (TPGS) granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
Regimen B: Prototype 1: 800 mg OZ439 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
Regimen C: Prototype 3: 800 mg OZ439 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets

There will be an interim decision after Part 1 to determine the formulation prototypes and the oral suspension volume to be administered in Part 2.

Part 2

Regimen D: Reference: 800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
Regimen E: Prototype 1 or 3: 800 mg OZ439 granules (oral suspension and rinse volume to be determined) and 960 mg (3 × 320 mg) PQP tablets
Regimen F: Prototype 1 or 3: 800 mg OZ439 granules (oral suspension and rinse volume to be determined) and 960 mg (3 × 320 mg) PQP tablets

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Regimen A: OZ439 + TPGS and PQP	Active comparator	Drug: OZ439 + TPGS, Drug: PQP800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
Regimen B: OZ439 Prototype 1 and PQP - 110mL	Experimental	Drug: OZ439 Prototype 1, Drug: PQP800 mg OZ439 Prototype 1 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
Regimen C: OZ439 Prototype 3 and PQP - 110mL	Experimental	Drug: OZ439 Prototype 3, Drug: PQP800 mg OZ439 Prototype 3 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
Regimen D: OZ439 + TPGS and PQP	Active comparator	Drug: OZ439 + TPGS, Drug: PQP800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
Regimen E: OZ439 Prototype 1 or 3 and PQP - XmL	Experimental	Drug: OZ439 Prototype 1, Drug: PQP800 mg OZ439 Prototype 1 or 3 granules (oral suspension and rinse volume to be determined) and 960 mg (3 × 320 mg) PQP tablets
Regimen F: OZ439 Prototype 1 or 3 and PQP - XmL	Experimental	Drug: OZ439 Prototype 3, Drug: PQP800 mg OZ439 Prototype 1 or 3 granules (oral suspension and rinse volume to be determined) and 960 mg (3 × 320 mg) PQP tablets

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Healthy males, or healthy females of non-childbearing potential ie surgically sterilised or post-menopausal
Body mass index of 18.0 to 30.0 kg/m2 inclusive. Total body weight >50 kg at screening.
Must agree to use an adequate method of contraception.
Normal laboratory tests as judged by the Investigator.
Must have QTcF ≤450 ms, QTcB ≤450 ms for male subjects, QTcF ≤470 ms, QTcB ≤470 ms for female subjects and PR interval ≤200 ms for screening and pre-dose ECG measurements.

Key exclusion criteria (15 listed)

Male subjects who have currently pregnant partners or who have partners planning to be pregnant.
Evidence or history of clinically significant disease, or current infection.3.
Clinically relevant abnormalities in the ECG.
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, heart rate ≤39 bpm.

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
OZ439 + TPGSAlso: 800 mg OZ439 + TPGS Reference Treatment	Drug	Regimen A: OZ439 + TPGS and PQP, Regimen D: OZ439 + TPGS and PQP
OZ439 Prototype 1Also: OZ439 Granules Prototype 1 Granules Formulation	Drug	Regimen B: OZ439 Prototype 1 and PQP - 110mL, Regimen E: OZ439 Prototype 1 or 3 and PQP - XmL
OZ439 Prototype 3Also: OZ439 Granules Prototype 3 Granules Formulation	Drug	Regimen C: OZ439 Prototype 3 and PQP - 110mL, Regimen F: OZ439 Prototype 1 or 3 and PQP - XmL
PQPAlso: PQP 960 mg tablets	Drug	Regimen A: OZ439 + TPGS and PQP, Regimen B: OZ439 Prototype 1 and PQP - 110mL, Regimen C: OZ439 Prototype 3 and PQP - 110mL, Regimen D: OZ439 + TPGS and PQP, Regimen E: OZ439 Prototype 1 or 3 and PQP - XmL, Regimen F: OZ439 Prototype 1 or 3 and PQP - XmL

Primary outcome

OZ439 Cmax
Time frame: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours post-dose
OZ439 Maximum observed concentration
OZ439 AUC(0-168 h)
Time frame: pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours post-dose
OZ439 Area under the plasma concentration (AUC) versus time curve
Piperaquine Cmax
Time frame: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours and Day36 post-dose
Piperaquine Maximum observed concentration
Piperaquine AUC(0-168 h)
Time frame: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours and Day36 post-dose
PQP Area under the plasma concentration versus time curve

Results and safety

Results posted to the registry on 14 Jan 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Regimen A: OZ439 + TPGS and PQP	8	8
Regimen B: OZ439 Prototype 1 and PQP - 110mL	8	8
Regimen C: OZ439 Prototype 3 and PQP - 110mL	8	8
Regimen D: OZ439 + TPGS and PQP	8	7
Regimen E: OZ439 Prototype 1 or 3 and PQP - 220mL	8	8
Regimen F: OZ439 Prototype 1 or 3 and PQP - 220mL	8	8

Primary outcome: OZ439 Cmax

Time frame: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Regimen A: OZ439 + TPGS and PQP n = 7	Regimen B: OZ439 Prototype 1 and PQP - 110mL n = 8	Regimen C: OZ439 Prototype 3 and PQP - 110mL n = 8	Regimen D: OZ439 + TPGS and PQP n = 6	Regimen E: OZ439 Prototype 1 or 3 and PQP - 220mL n = 8	Regimen F: OZ439 Prototype 1 or 3 and PQP - 220mL n = 8
Value	1600 (36.6)	824 (38.3)	616 (49.4)	1530 (13.2)	999 (40.8)	730 (35.7)

Population analysed: The PK population was to include all valid profiles from subjects dosed with IMP. 45 subjects were included in the PK population. 3 subjects vomited approximately 1 to 2 h after dosing and were excluded.

Primary outcome: OZ439 AUC(0-168 h)

Time frame: pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: ng*h/mL

Measure	Regimen A: OZ439 + TPGS and PQP n = 7	Regimen B: OZ439 Prototype 1 and PQP - 110mL n = 8	Regimen C: OZ439 Prototype 3 and PQP - 110mL n = 8	Regimen D: OZ439 + TPGS and PQP n = 6	Regimen E: OZ439 Prototype 1 or 3 and PQP - 220mL n = 8	Regimen F: OZ439 Prototype 1 or 3 and PQP - 220mL n = 8
Value	15300 (26.1)	7920 (26.4)	5610 (38.1)	14000 (29.6)	9550 (57.5)	7100 (45.7)

Primary outcome: Piperaquine Cmax

Time frame: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours and Day36 post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Regimen A: OZ439 + TPGS and PQP n = 7	Regimen B: OZ439 Prototype 1 and PQP - 110mL n = 8	Regimen C: OZ439 Prototype 3 and PQP - 110mL n = 8	Regimen D: OZ439 + TPGS and PQP n = 6	Regimen E: OZ439 Prototype 1 or 3 and PQP - 220mL n = 8	Regimen F: OZ439 Prototype 1 or 3 and PQP - 220mL n = 8
Value	183 (124.9)	62.1 (154.4)	100 (80.7)	119 (52.1)	91.8 (108.2)	95.7 (81.5)

Primary outcome: Piperaquine AUC(0-168 h)

Time frame: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours and Day36 post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: ng*h/mL

Measure	Regimen A: OZ439 + TPGS and PQP n = 7	Regimen B: OZ439 Prototype 1 and PQP - 110mL n = 8	Regimen C: OZ439 Prototype 3 and PQP - 110mL n = 8	Regimen D: OZ439 + TPGS and PQP n = 6	Regimen E: OZ439 Prototype 1 or 3 and PQP - 220mL n = 8	Regimen F: OZ439 Prototype 1 or 3 and PQP - 220mL n = 8
Value	3740 (61.2)	1940 (69.5)	2980 (47.6)	2860 (40.2)	2550 (47.8)	2470 (60.8)

Adverse events

Time frame: Up to Day 36 post-dose.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Regimen A: OZ439 + TPGS and PQP	0 of 8 (0%)	4 of 8 (50%)	Not reported
Regimen B: OZ439 Prototype 1 and PQP - 110mL	1 of 8 (12.5%)	4 of 8 (50%)	Not reported
Regimen C: OZ439 Prototype 3 and PQP - 110mL	0 of 8 (0%)	3 of 8 (37.5%)	Not reported
Regimen D: OZ439 + TPGS and PQP	0 of 8 (0%)	6 of 8 (75%)	Not reported
Regimen E: OZ439 Prototype 1 or 3 and PQP - 220mL	0 of 8 (0%)	5 of 8 (62.5%)	Not reported
Regimen F: OZ439 Prototype 1 or 3 and PQP - 220mL	0 of 8 (0%)	5 of 8 (62.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Malaria

Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
RecruitingObservational study
Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali
Malaria
RecruitingPhase 1
Safety, Tolerability and Efficacy of PfSPZ-LARC2 Vaccine Against CHMI in Malaria-Naïve Adults
Malaria Falciparum
Not yet recruiting
Three-arm Cluster Randomised Control Trial Evaluation of Guardian Spatial Emanator as a Complimentary Vector Control Tool in Papua New Guinea
Malaria

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.

Fiona Macintyre, PhD study director

Medicines for Malaria Ventire

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 OZ439 + TPGS, OZ439 Prototype 1 and OZ439 Prototype 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 5 inclusion and 15 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 8 Feb 2016. 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 14 Jan 2016). 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 Cmax (time frame: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours post-dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02387580.

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 8 Feb 2016.