MalariaPhase 1NCT01615822
Safety, Tolerability & Pharmacokinetics (PK) of Co-administered Single Doses of OZ439 and Mefloquine (MQ) in Healthy Volunteers
A Phase 1 study testing OZ439 100mg, OZ439 400mg and MQ 250 mg, single dose in people with Malaria, run by Medicines for Malaria Venture at 1 site in South Africa.
Trial summary
OZ439 is a novel, synthetic trioxolane medicine which is related to artemisinin, but has the advantage of a longer elimination half-life so is being developed to be administered together with a potential partner drug e.g. mefloquine as a single dose cure for uncomplicated malaria. 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 100mg, OZ439 400mg and MQ 250 mg, single dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteSouth Africa
- Study dates
- Aug 2012to Apr 2013
- 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 and non-childbearing potential female volunteers of between 18 and 55 years of age
- Female volunteers must have a negative serum pregnancy test at screening
- Females must be of non-childbearing potential
- Male volunteers and their partner(s) must agree to use a double barrier method of contraception for at least 14 days prior to first dose of study drug through 90 days after the last dose.
- Body mass Index between 18 and 30kg/m2, inclusive; and a total body weight >50 kg
- Laboratory tests at screening within normal ranges or not clinically significant as judged by the Investigator.
Who cannot join
- Received an investigational drug or participated in another research study within 30 days of the first dose of study drug or at any time through the study
- Evidence of current or history of clinically significant oncologic, pulmonary, hepatic, cardiovascular, gastrointestinal, haematologic, metabolic, neurological, immunologic, nephrologic, endocrine, psychiatric disease, or clinically significant current infection.
- Any condition that could possibly affect drug absorption, such as gastrectomy, diarrhea and lactose intolerance
- Use of any medications, vitamins, herbal supplements, dietary supplements or vaccinations within 14 days of the first dose of study drug or at any time through the study, unless prior approval is granted. This includes any drugs that are substrates, inhibitors or inducers of CYP3A4. Intermittent use of acetaminophen at doses of up to 2g/day is permitted
- History of drug or alcohol abuse within 2 years of Screening
- History of alcohol consumption within 24 hours of any study visit
Show all 13Show fewer
- Tobacco users
- Consumption of fruit juices within 7 days prior to dosing
- Participation in unaccustomed strenuous exercise within 7 days prior to
- Positive urine drug screen
- Positive test for HIV-1, HBsAg or HCV
- Known hypersensitivity to MQ or artemisinins
- QTcF greater than 450msec
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Division of Clinical Pharmacology, University of Cape Town
Cape Town, 7925
About this study
Official title: A Phase I Healthy Volunteer Study Investigating the Safety, Tolerability & Pharmacokinetics of Co-administered Single Doses of OZ439 and Mefloquine
OZ439 is a novel, synthetic trioxolane medicine which is related to artemisinin, but has the advantage of a longer elimination half-life so is being developed to be administered together with a potential partner drug e.g. mefloquine as a single dose cure for uncomplicated malaria. The study findings will be used to inform the dose and design of future studies. The aim of the study is to establish the safety, tolerability and pharmacokinetics of co-administered OZ439 and MQ at a range of doses up to the maximum tolerated dose, in healthy volunteers.
- Conditions
- Malaria
- Being tested
- OZ439 100mg, OZ439 400mg, MQ 250 mg, single dose, MQ 750mg, single dose, Placebo
- Keywords
- Malaria, PK, OZ439, Mefloquine, Healthy Volunteers
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OZ439 100mgDrug
OZ439 100mg oral suspension, single dose
OZ439 400mgDrug
OZ439 400mg oral suspension, single dose
MQ 250 mg, single doseDrug
Mefloquine 250 mg tablet, single dose
MQ 750mg, single doseDrug
Mefloquine 750mg oral tablet, single dose
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| OZ439 100mg single dose | Experimental | OZ439 100mg single dose oral suspension Receives: Drug: OZ439 100mg |
| OZ439 100mg plus MQ 250mg single doses | Experimental | Single dose OZ439 100mg oral suspension in combination with single dose MQ 250mg tablet Receives: Drug: OZ439 100mg; Drug: MQ 250 mg, single dose |
| OZ439 400mg single dose | Experimental | OZ439 400mg single dose oral suspension Receives: Drug: OZ439 400mg |
| OZ439 400mg plus MQ 750mg single doses | Experimental | Single dose OZ439 400mg oral suspension in combination with single dose MQ 750mg tablets Receives: Drug: OZ439 400mg; Drug: MQ 750mg, single dose |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
OZ439 AUC0-t
Area under the plasma concentration versus time curve (AUC) of OZ439
Measured: Up to 42 days post-dose
Secondary outcomes (3)
OZ439 Cmax
Peak Plasma Concentration (Cmax) of OZ439
Measured: Up to 42 days post-dose
MQ AUC0-t
Area under the plasma concentration versus time curve (AUC) of MQ
Measured: Up to 42 days post-dose
MQ Cmax
Peak Plasma Concentration (Cmax) of MQ
Measured: Up to 42 days 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 Jun 2012 (estimated)
- Study startAug 2012
- Primary completionApr 2013
- Study completionApr 2013
Why it stopped: Decision taken to halt progression of mefloquine as a potential partner for OZ439 as a single dose cure due to low probability of success
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicines for Malaria Venture
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cape Town
- Responsible party
- Sponsor
- Investigators
- Karen I Barnes, Principal investigator, University of Cape Town
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01615822
- Sponsor's protocol ID
- MMV_OZ439_12_001
- Status last verified
- Mar 2015
- First submitted
- 7 Jun 2012
- Last updated
- 16 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Healthy Volunteer Study Investigating the Safety, Tolerability & Pharmacokinetics of Co-administered Single Doses of OZ439 and Mefloquine
- ClinicalTrials.gov ID
- NCT01615822
- Acronym / sponsor ID
- MMV_OZ439_12_001
- Conditions
- Malaria
- Keywords
- Malaria, PK, OZ439, Mefloquine, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Decision taken to halt progression of mefloquine as a potential partner for OZ439 as a single dose cure due to low probability of success
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Medicines for Malaria VentureUniversity, hospital or other
- Collaborators
- University of Cape Town
- Study start
- Aug 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 11 Jun 2012 (estimated)
- Results
- Posted 26 Mar 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 novel, synthetic trioxolane medicine which is related to artemisinin, but has the advantage of a longer elimination half-life so is being developed to be administered together with a potential partner drug e.g. mefloquine as a single dose cure for uncomplicated malaria. The study findings will be used to inform the dose and design of future studies. The aim of the study is to establish the safety, tolerability and pharmacokinetics of co-administered OZ439 and MQ at a range of doses up to the maximum tolerated dose, in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| OZ439 100mg single dose | Experimental | Drug: OZ439 100mgOZ439 100mg single dose oral suspension |
| OZ439 100mg plus MQ 250mg single doses | Experimental | Drug: OZ439 100mg, Drug: MQ 250 mg, single doseSingle dose OZ439 100mg oral suspension in combination with single dose MQ 250mg tablet |
| OZ439 400mg single dose | Experimental | Drug: OZ439 400mgOZ439 400mg single dose oral suspension |
| OZ439 400mg plus MQ 750mg single doses | Experimental | Drug: OZ439 400mg, Drug: MQ 750mg, single doseSingle dose OZ439 400mg oral suspension in combination with single dose MQ 750mg tablets |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy male and non-childbearing potential female volunteers of between 18 and 55 years of age
- Female volunteers must have a negative serum pregnancy test at screening
- Females must be of non-childbearing potential
- Male volunteers and their partner(s) must agree to use a double barrier method of contraception for at least 14 days prior to first dose of study drug through 90 days after the last dose.
- Body mass Index between 18 and 30kg/m2, inclusive; and a total body weight >50 kg
Key exclusion criteria (13 listed)
- Received an investigational drug or participated in another research study within 30 days of the first dose of study drug or at any time through the study
- Evidence of current or history of clinically significant oncologic, pulmonary, hepatic, cardiovascular, gastrointestinal, haematologic, metabolic, neurological, immunologic, nephrologic, endocrine, psychiatric disease, or clinically significant current infection.
- Any condition that could possibly affect drug absorption, such as gastrectomy, diarrhea and lactose intolerance
- Use of any medications, vitamins, herbal supplements, dietary supplements or vaccinations within 14 days of the first dose of study drug or at any time through the study, unless prior approval is granted. This includes any drugs that are substrates, inhibitors or inducers of CYP3A4. Intermittent use of acetaminophen at doses of up to 2g/day is permitted
- History of drug or alcohol abuse within 2 years of Screening
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 100mgOZ439 100mg oral suspension, single dose | Drug | OZ439 100mg plus MQ 250mg single doses, OZ439 100mg single dose |
| OZ439 400mgOZ439 400mg oral suspension, single dose | Drug | OZ439 400mg plus MQ 750mg single doses, OZ439 400mg single dose |
| MQ 250 mg, single doseMefloquine 250 mg tablet, single dose | Drug | OZ439 100mg plus MQ 250mg single doses |
| MQ 750mg, single doseMefloquine 750mg oral tablet, single dose | Drug | OZ439 400mg plus MQ 750mg single doses |
| Placebo | Drug | Placebo |
Primary outcome
OZ439 AUC0-t
Time frame: Up to 42 days post-dose
Area under the plasma concentration versus time curve (AUC) of OZ439
3 secondary outcomes
OZ439 Cmax
Time frame: Up to 42 days post-dose
MQ AUC0-t
Time frame: Up to 42 days post-dose
MQ Cmax
Time frame: Up to 42 days post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 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.
Karen I Barnes principal investigator
University of Cape Town
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 100mg, OZ439 400mg and MQ 250 mg, single dose in people with Malaria, run by Medicines for Malaria Venture at 1 site in South Africa.
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 6 inclusion and 13 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: stopped early, as of the sponsor's last update on 16 Apr 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 South Africa. 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 26 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 AUC0-t (time frame: Up to 42 days post-dose). 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 16 Apr 2015.