Malaria FalciparumPhase 1NCT00928083
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of OZ439 in Healthy Male and Female Subjects
A Phase 1 study testing OZ439 50mg API capsules, OZ439 200mg API capsules and OZ439 400mg aqueous dispersion in people with Malaria Falciparum and Malaria Vivax, run by Medicines for Malaria Venture at 1 site in United States.
Trial summary
OZ439 is a synthetic trioxolane that has potential value as a peroxide antimalarial agent. This was a Phase I, single-centre, multi-component, double-blind, randomised, placebo-controlled study in healthy male and female subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria Falciparum, Malaria Vivax, Healthy Volunteers
- What is being tested?
- OZ439 50mg API capsules, OZ439 200mg API capsules and OZ439 400mg aqueous dispersion
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Dec 2009
- 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 male//female subjects between 18- 55 years of age (inclusive).
- Body mass Index (BMI) between 18 - 30 kg/m2, inclusive; and a total body weight >60 kg (132 lbs).
- Healthy as determined by pre-study medical history, PE, 12 Lead ECG.
- Females of childbearing potential must use 1 of birth control methods throughout study and for 30 days after last dose of study drug:
- Surgically sterile (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) 6 months minimum prior to first dose of study drug.
- Intrauterine device (IUD) in place for at least 3 months prior to first dose of study drug.
Show all 14Show fewer
- Barrier methods (condom or diaphragm) with spermicide starting at least 14 days prior to first dose of study drug through 30 days after last dose of study drug.
- Surgical sterilization of the partner(s) (vasectomy with zero sperm count for 6 months minimum prior to the first dose of study drug).
- Hormonal contraceptives starting at least 3 months prior to first dose of study drug. In addition, subjects must agree to use a barrier method (condom or diaphragm) with spermicide at least 14 days prior to first dose of study drug through 30 days after the last dose of study drug.
- Post-menopausal women with amenorrhea for at least 1 year will be eligible confirmed by FSH.
- Male subjects must agree to use double barrier method of contraception, from time of first dose of study drug through 90 days after last dose of study drug and must also agree to not donate sperm for 90 days after last dose of study drug. Clinical laboratory tests within the reference ranges.
- Able/willing to give written informed consent.
- Willing/to adhere to lifestyle guideline restrictions outlined in protocol.
- Willing and able to be confined to Clinical Research Unit as required by the protocol.
Who cannot join
- Evidence/history of clinically significant oncologic, pulmonary, hepatic, cardiovascular, hematologic, metabolic, neurological, immunologic, nephrologic, endocrine, psychiatric disease, current infection.
- Evidence/history of clinically significant gastrointestinal (some exclusions exist) disease, current infection.
- Any condition that affecting drug absorption, e.g., gastrectomy.
- History of post-antibiotic colitis.
- Breast feeding.
- QTc greater than 450 msec for males and 470 msec for females as corrected by the Bazett formula.
Show all 21Show fewer
- History of drug or alcohol abuse within the past 2 years prior to Screening.
- Tobacco users
- Received investigational drug/ participated in another research study within 30 days of first dose of study drug in any part of study.
- Use of prescription drugs within 14 days prior to the first dose of study drug in Period 1, or need for any antibiotic during study.
- Received any non prescription meds, vitamins, herbal/dietary supplements within 7 days of administration of first dose of study drug in Period 1 (exceptions exist)
- Consumed alcohol within 72 hours of Day -1 in any part of study, or have a positive alcohol screen at screening or each admission to Clinical Research Unit (CRU).
- Consumed grapefruit juice or juices containing grapefruit or ate grapefruit within 7 days prior to first dose of study drug in any part of study.
- Positive serum pregnancy test at the Screening Visit or on Day -1 prior to inclusion in any part of the study.
- Positive test for HIV-1, HBsAg,HCV.
- Positive urine drug screen at Screening or admission to CRU.
- History of intolerance/ hypersensitivity to artemisinins.
- Likelihood of requiring treatment during study period with drugs not permitted by protocol.
- Subjects who have donated blood or experienced significant blood loss within 60 days of screening for study.
- Subjects whose hemoglobin is <12.5 g/dL for males/ <11.5 g/dL for females.
- Any concern by investigator regarding safe participation of the subject in study or for any other reason investigator considers subject inappropriate for participation in study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Comprehensive Phase One Miramar; 3400 Enterprise Way
Miramar, Florida, 33025
About this study
Official title: A Phase I Study To Investigate The Safety, Tolerability And Pharmacokinetic Profile Of OZ439 In Healthy Male and Female Subjects
OZ439 is a synthetic trioxolane that has potential value as a peroxide antimalarial agent.
This was a Phase I, single-centre, multi-component, double-blind, randomised, placebo-controlled study in healthy male and female subjects. The study was conducted in 3 parts:
Read more
- Part A investigated the safety, tolerability and pharmacokinetics (PK) of single oral escalating doses of OZ439. Up to 6 dose levels will be investigated to estimate dose proportionality.
- Part B, the effect of food on a single oral dose of OZ439 was investigated in a 2-way crossover design.
- Part C investigated the safety, tolerability and PK profile of multiple oral doses of OZ439.
The starting oral dose was 50 mg and the maximum single dose to be administered did not exceed 1600 mg per subject. The maximum duration of dosing proposed was 3 days.
- Conditions
- Malaria Falciparum, Malaria Vivax, Healthy Volunteers
- Being tested
- OZ439 50mg API capsules, OZ439 200mg API capsules, OZ439 400mg aqueous dispersion, OZ439 800mg aqueous dispersion, OZ439 100mg API capsules
- Keywords
- Phase I, Safety and tolerability, Pharmacokinetic, synthetic peroxide, trioxolane, treatment of erythrocytic stages of malaria
- Medical subject headings
- Malaria, Falciparum, Malaria, Vivax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OZ439 50mg API capsulesDrug
Also called OZ439
OZ439 200mg API capsulesDrug
Also called OZ439
OZ439 400mg aqueous dispersionDrug
OZ439 800mg aqueous dispersionDrug
Also called OZ439
OZ439 100mg API capsulesDrug
Also called OZ439
OZ439 100mg (2x50mg API capsules)
OZ439 400mg API capsulesDrug
Also called OZ439
OZ439 400mg (2x200mg API capsules)
OZ439 1600mg aqueous dispersionDrug
Also called OZ439
OZ439 800mg API capsulesDrug
Also called OZ439
OZ439 800mg (4x200 API capsules)
OZ439 1200mg API capsulesDrug
Also called OZ439
OZ439 1200mg (6x200mg API capsules)
PlaceboDrug
OZ439 200mg aqueous dispersionDrug
Also called OZ439
| Study group | Role | What they receive |
|---|---|---|
| Part A - 50 mg Single Dose | Experimental | OZ439 Single doses of 50mg (capsules) Receives: Drug: OZ439 50mg API capsules |
| Part A - 100mg Single Dose | Experimental | OZ439 Single doses of 100mg (capsules) Receives: Drug: OZ439 100mg API capsules |
| Part A - 200mg Single Dose | Experimental | OZ439 Single doses of 200mg (capsules) Receives: Drug: OZ439 200mg API capsules |
| Part A - 400mg Single Dose | Experimental | OZ439 Single doses of 400mg (capsules) Receives: Drug: OZ439 400mg API capsules |
| Part A - 400mg Single Dose + Food | Experimental | OZ439 Single doses of 400mg (capsules) administered with food. Receives: Drug: OZ439 400mg API capsules |
| Part A - 400mg AD Single Dose | Experimental | OZ439 Single doses of 400mg (aqueous dispersion) Receives: Drug: OZ439 400mg aqueous dispersion |
| Part A - 800mg Single Dose | Experimental | OZ439 Single doses of 800mg (capsules) Receives: Drug: OZ439 800mg API capsules |
| Part A - 800mg AD Single Dose | Experimental | OZ439 Single doses of 800mg (aqueous dispersion) Receives: Drug: OZ439 800mg aqueous dispersion |
| Part A - 1200mg Single Dose | Experimental | OZ439 Single doses of 1200mg (capsules) Receives: Drug: OZ439 1200mg API capsules |
| Part A - 1600mg AD Single Dose | Experimental | OZ439 Single doses of 800mg (aqueous dispersion) Receives: Drug: OZ439 1600mg aqueous dispersion |
| Part A - Placebo | Placebo comparator | Placebo control for Single rising Part A Receives: Drug: Placebo |
| Part B - 800mg AD Single Dose Fed | Experimental | Single dose of OZ439 800mg aqueous dispersion administered under fed conditions Receives: Drug: OZ439 800mg aqueous dispersion |
| Part B - 800mg AD Single Dose Fast | Experimental | Single dose of OZ439 800mg aqueous dispersion administered under fast conditions Receives: Drug: OZ439 800mg aqueous dispersion |
| Part C - 200mg AD Multiple Dose | Experimental | 200mg aqueous solution OZ439 or placebo once daily for 3 days fasted Receives: Drug: OZ439 200mg aqueous dispersion |
| Part C - 400mg AD Multiple Dose | Experimental | 400mg aqueous solution OZ439 or placebo once daily for 3 days fasted Receives: Drug: OZ439 400mg aqueous dispersion |
| Part C - 800mg AD Multiple Dose | Experimental | 800mg aqueous solution OZ439 or placebo once daily for 3 days fasted Receives: Drug: OZ439 800mg aqueous dispersion |
| Part C - Placebo | Placebo comparator | Placebo control for Multiple rising Part C Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Safety/Tolerability evaluation took into account the recorded AE profile, clinical laboratory safety tests, vital signs, 12 lead and continuous (Parts A and C) ECG monitoring, audiometry/Brainstem Auditory Evoked Potentials (BAEP) parameters (Parts A and C) including any additional tests required to evaluate any safety concerns.
Measured: From screening and at 10 (+/-2) days after last dose of study medication
Secondary outcomes (6)
OZ439 AUC0-t
Area under the plasma concentration-time curve from zero to time t of the last measured concentration above the limit of quantification (AUC0-t).
Measured: Samples collected from Pre-dose up to 96h post dose
OZ439 AUC0-∝
Area under the plasma concentration-time curve from zero to infinity (AUC0-∝).
Measured: Samples collected from Pre-dose up to 96h post dose
OZ439 Cmax
Maximum observed plasma drug concentration (Cmax).
Measured: Samples collected from Pre-dose up to 96h post dose
OZ439 Tmax
Time to maximum observed plasma drug concentration of OZ439
Measured: Samples collected from Pre-dose up to 96h post dose
OZ439 t1/2
Apparent terminal half-life (t1/2)
Measured: Samples collected from Pre-dose up to 96h post dose
OZ439 Rac
Accumulation index is the ratio of drug exposure observed during a dosing interval at steady-state divided by drug exposure after a single first dose, as described by the following equations:
Accumulation index (Rac) = AUC0-(Day 3)/ AUC0-(Day 1)
Measured: Samples collected from Pre-dose up to 96h post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2009 (estimated)
- Study startApr 2009
- Primary completionOct 2009
- Study completionDec 2009
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malaria FalciparumStudies 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicines for Malaria Venture
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joerg Moehrle, PhD, Study director, Medicines for Malaria VentureMaria Gutierrez, MD, Principal investigator, Comprehensive Phase One Miramar, 3400 Enterprise Way, Miramar, FL 33025
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00928083
- Sponsor's protocol ID
- MMV_OZ439_09_001
- Status last verified
- Jan 2015
- First submitted
- 24 Jun 2009
- Last updated
- 8 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Moehrle JJ, Duparc S, Siethoff C, van Giersbergen PL, Craft JC, Arbe-Barnes S, Charman SA, Gutierrez M, Wittlin S, Vennerstrom JL. First-in-man safety and pharmacokinetics of synthetic ozonide OZ439 demonstrates an improved exposure profile relative to other peroxide antimalarials. Br J Clin Pharmacol. 2013 Feb;75(2):524-37. doi: 10.1111/j.1365-2125.2012.04368.x.
PubMed 22759078
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study To Investigate The Safety, Tolerability And Pharmacokinetic Profile Of OZ439 In Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT00928083
- Acronym / sponsor ID
- MMV_OZ439_09_001
- Conditions
- Malaria Falciparum, Malaria Vivax, Healthy Volunteers
- Keywords
- Phase I, Safety and tolerability, Pharmacokinetic, synthetic peroxide, trioxolane, treatment of erythrocytic stages of malaria
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Medicines for Malaria VentureUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 25 Jun 2009 (estimated)
- Results
- Posted 8 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OZ439 is a synthetic trioxolane that has potential value as a peroxide antimalarial agent.
This was a Phase I, single-centre, multi-component, double-blind, randomised, placebo-controlled study in healthy male and female subjects. The study was conducted in 3 parts:
- Part A investigated the safety, tolerability and pharmacokinetics (PK) of single oral escalating doses of OZ439. Up to 6 dose levels will be investigated to estimate dose proportionality.
- Part B, the effect of food on a single oral dose of OZ439 was investigated in a 2-way crossover design.
- Part C investigated the safety, tolerability and PK profile of multiple oral doses of OZ439.
The starting oral dose was 50 mg and the maximum single dose to be administered did not exceed 1600 mg per subject. The maximum duration of dosing proposed was 3 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 17
| Arm | Type | Receives |
|---|---|---|
| Part A - 50 mg Single Dose | Experimental | Drug: OZ439 50mg API capsulesOZ439 Single doses of 50mg (capsules) |
| Part A - 100mg Single Dose | Experimental | Drug: OZ439 100mg API capsulesOZ439 Single doses of 100mg (capsules) |
| Part A - 200mg Single Dose | Experimental | Drug: OZ439 200mg API capsulesOZ439 Single doses of 200mg (capsules) |
| Part A - 400mg Single Dose | Experimental | Drug: OZ439 400mg API capsulesOZ439 Single doses of 400mg (capsules) |
| Part A - 400mg Single Dose + Food | Experimental | Drug: OZ439 400mg API capsulesOZ439 Single doses of 400mg (capsules) administered with food. |
| Part A - 400mg AD Single Dose | Experimental | Drug: OZ439 400mg aqueous dispersionOZ439 Single doses of 400mg (aqueous dispersion) |
| Part A - 800mg Single Dose | Experimental | Drug: OZ439 800mg API capsulesOZ439 Single doses of 800mg (capsules) |
| Part A - 800mg AD Single Dose | Experimental | Drug: OZ439 800mg aqueous dispersionOZ439 Single doses of 800mg (aqueous dispersion) |
| Part A - 1200mg Single Dose | Experimental | Drug: OZ439 1200mg API capsulesOZ439 Single doses of 1200mg (capsules) |
| Part A - 1600mg AD Single Dose | Experimental | Drug: OZ439 1600mg aqueous dispersionOZ439 Single doses of 800mg (aqueous dispersion) |
| Part A - Placebo | Placebo comparator | Drug: PlaceboPlacebo control for Single rising Part A |
| Part B - 800mg AD Single Dose Fed | Experimental | Drug: OZ439 800mg aqueous dispersionSingle dose of OZ439 800mg aqueous dispersion administered under fed conditions |
| Part B - 800mg AD Single Dose Fast | Experimental | Drug: OZ439 800mg aqueous dispersionSingle dose of OZ439 800mg aqueous dispersion administered under fast conditions |
| Part C - 200mg AD Multiple Dose | Experimental | Drug: OZ439 200mg aqueous dispersion200mg aqueous solution OZ439 or placebo once daily for 3 days fasted |
| Part C - 400mg AD Multiple Dose | Experimental | Drug: OZ439 400mg aqueous dispersion400mg aqueous solution OZ439 or placebo once daily for 3 days fasted |
| Part C - 800mg AD Multiple Dose | Experimental | Drug: OZ439 800mg aqueous dispersion800mg aqueous solution OZ439 or placebo once daily for 3 days fasted |
| Part C - Placebo | Placebo comparator | Drug: PlaceboPlacebo control for Multiple rising Part C |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Healthy male//female subjects between 18- 55 years of age (inclusive).
- Body mass Index (BMI) between 18 - 30 kg/m2, inclusive; and a total body weight >60 kg (132 lbs).
- Healthy as determined by pre-study medical history, PE, 12 Lead ECG.
- Females of childbearing potential must use 1 of birth control methods throughout study and for 30 days after last dose of study drug:
- Post-menopausal women with amenorrhea for at least 1 year will be eligible confirmed by FSH.
Key exclusion criteria (21 listed)
- Evidence/history of clinically significant oncologic, pulmonary, hepatic, cardiovascular, hematologic, metabolic, neurological, immunologic, nephrologic, endocrine, psychiatric disease, current infection.
- Evidence/history of clinically significant gastrointestinal (some exclusions exist) disease, current infection.
- Any condition that affecting drug absorption, e.g., gastrectomy.
- History of post-antibiotic colitis.
- Breast feeding.
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 50mg API capsulesAlso: OZ439 | Drug | Part A - 50 mg Single Dose |
| OZ439 200mg API capsulesAlso: OZ439 | Drug | Part A - 200mg Single Dose |
| OZ439 400mg aqueous dispersion | Drug | Part A - 400mg AD Single Dose, Part C - 400mg AD Multiple Dose |
| OZ439 800mg aqueous dispersionAlso: OZ439 | Drug | Part A - 800mg AD Single Dose, Part B - 800mg AD Single Dose Fast, Part B - 800mg AD Single Dose Fed, Part C - 800mg AD Multiple Dose |
| OZ439 100mg API capsulesAlso: OZ439OZ439 100mg (2x50mg API capsules) | Drug | Part A - 100mg Single Dose |
| OZ439 400mg API capsulesAlso: OZ439OZ439 400mg (2x200mg API capsules) | Drug | Part A - 400mg Single Dose, Part A - 400mg Single Dose + Food |
| OZ439 1600mg aqueous dispersionAlso: OZ439 | Drug | Part A - 1600mg AD Single Dose |
| OZ439 800mg API capsulesAlso: OZ439OZ439 800mg (4x200 API capsules) | Drug | Part A - 800mg Single Dose |
| OZ439 1200mg API capsulesAlso: OZ439OZ439 1200mg (6x200mg API capsules) | Drug | Part A - 1200mg Single Dose |
| Placebo | Drug | Part A - Placebo, Part C - Placebo |
| OZ439 200mg aqueous dispersionAlso: OZ439 | Drug | Part C - 200mg AD Multiple Dose |
Primary outcome
Adverse Events
Time frame: From screening and at 10 (+/-2) days after last dose of study medication
Safety/Tolerability evaluation took into account the recorded AE profile, clinical laboratory safety tests, vital signs, 12 lead and continuous (Parts A and C) ECG monitoring, audiometry/Brainstem Auditory Evoked Potentials (BAEP) parameters (Parts A and C) including any additional tests required to evaluate any safety concerns.
6 secondary outcomes
OZ439 AUC0-t
Time frame: Samples collected from Pre-dose up to 96h post dose
OZ439 AUC0-∝
Time frame: Samples collected from Pre-dose up to 96h post dose
OZ439 Cmax
Time frame: Samples collected from Pre-dose up to 96h post dose
OZ439 Tmax
Time frame: Samples collected from Pre-dose up to 96h post dose
OZ439 t1/2
Time frame: Samples collected from Pre-dose up to 96h post dose
OZ439 Rac
Time frame: Samples collected from Pre-dose up to 96h post dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22759078Moehrle JJ, Duparc S, Siethoff C, van Giersbergen PL, Craft JC, Arbe-Barnes S, Charman SA, Gutierrez M, Wittlin S, Vennerstrom JL. First-in-man safety and pharmacokinetics of synthetic ozonide OZ439 demonstrates an improved exposure profile relative to other peroxide antimalarials. Br J Clin Pharmacol. 2013 Feb;75(2):524-37. doi: 10.1111/j.1365-2125.2012.04368.x.
Related trials for Malaria Falciparum
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
Active, not recruitingPhase 4
Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity Diagnostics
Malaria,Falciparum, Malaria in Pregnancy
Not yet recruiting
Permethrin-Treated Baby Wraps for Malaria Prevention in Refugee Settings
Malaria (Plasmodium Falciparum), Malaria Incidence
RecruitingPhase 1/2
DON in Pediatric Cerebral Malaria
Malaria, Cerebral
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.
Joerg Moehrle, PhD study director
Medicines for Malaria Venture
Maria Gutierrez, MD principal investigator
Comprehensive Phase One Miramar, 3400 Enterprise Way, Miramar, FL 33025
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 50mg API capsules, OZ439 200mg API capsules and OZ439 400mg aqueous dispersion in people with Malaria Falciparum and Malaria Vivax, run by Medicines for Malaria Venture at 1 site in United States.
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 14 inclusion and 21 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 Jan 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 States. 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. Some participants in this study may receive a placebo. 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 8 Jan 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?
Adverse Events (time frame: From screening and at 10 (+/-2) days after last dose of study medication). 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 NCT00928083, which also lists 1 linked publication.
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 Jan 2015.