MalariaPhase 1NCT04069221
Absolute BA and OZ439 PK Effect of Different OZ439 Dose Volumes and Cobicistat Co-administration Study
A Phase 1 study testing Single oral dose of 800 mg OZ439, Single oral dose of 400 mg OZ439 and Single oral dose of cobicistat in people with Malaria, run by Medicines for Malaria Venture at 1 site in Netherlands.
Trial summary
This study is an open-label, two-part study to determine the absolute bioavailability (BA) of OZ439 using simultaneous intravenous [14C]-OZ439 microdose/800mg oral dosing and to investigate the pharmacokinetics (PK) of OZ439 granules administered as single doses suspended in different volumes and when co-administered… 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?
- Single oral dose of 800 mg OZ439, Single oral dose of 400 mg OZ439 and Single oral dose of cobicistat
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteNetherlands
- Study dates
- 28 Feb 2017to 30 May 2017
- 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
- Body mass index (BMI) : 18.0-30.0 kg/m2, inclusive, at screening
- Weight : >50 kg, at screening
- Status : healthy subjects
- Female subjects must be of non-childbearing potential (either surgically sterilized or physiologically incapable of becoming pregnant, or post-menopausal [defined as spontaneous amenorrhoea for at least 1 year or spontaneous amenorrhoea for at least 6 months confirmed by a follicle stimulating hormone (FSH) result indicating a post-menopausal status]) and have a negative pregnancy test at screening and at (each) admission to the clinical research center. As all female subjects must be of non-childbearing potential, they are not required to use any contraception during this study.
- Male subjects must use adequate contraception and not donate sperm from (first) admission to the clinical research center until 90 days after the follow-up visit. Adequate contraception for the male subject (and his female partner) is defined as surgical sterilization (vasectomy), using hormonal contraceptives (implantable, patch, oral, injectable) or an intrauterine device or system combined with at least 1 of the following forms of contraception (barrier method): a diaphragm or cervical cap, or a condom. Also, total abstinence, in accordance with the lifestyle of the subject is acceptable.
- Must have QTcF ≤450 ms and QTcB ≤450 ms (male subjects); QTcF ≤470 ms and QTcB ≤470 ms (female subjects), and PR-interval ≤200 ms for screening, and Day -1 and pre-dose ECG measurements of the (first) treatment period
Show all 9Show fewer
- Ability and willingness to abstain from alcohol and methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, energy drinks) from 48 hours prior to (each) admission to the clinical research center
- Willing and able to communicate and participate in the whole study
- Willing and able to sign the ICF
Who cannot join
- A subject who meets any of the following exclusion criteria will not be eligible for inclusion in the study:
- Male subjects who have currently pregnant partners or who have partners planning to be pregnant in the 90 days after discharge
- Evidence or history of clinically significant oncological, pulmonary, chronic respiratory, hepatic, cardiovascular, hematological, metabolic, neurological, immunological, nephrological, endocrine or psychiatric disease, or current infection
- Clinically relevant (as decided by the Principal Investigator [PI]) abnormalities in the 12-lead ECG, 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, heart rate ≤39 beats per minute (bpm)
Show all 27Show fewer
- Electrolyte disturbances, particularly hypokalemia, hypocalcemia or hypomagnesemia
- Any condition that could possibly affect drug absorption, e.g. gastrectomy or diarrhea
- History of post-antibiotic colitis
- History of any drug or alcohol abuse in the past 2 years prior to screening
- Subjects who regularly smoke more than 5 cigarettes a day
- Receipt of an investigational drug or participation in another clinical research study within 90 days prior to the first dose of study drug
- Subjects who are PRA employees, or immediate family members of PRA or Sponsor employees
- Subjects who have previously been enrolled in this study
- Use of moderate/strong inhibitors or inducers of CYP cytochromes or transporters within 30 days or 5 half-lives (whichever is longer) prior to the first dose of study drug
- Consumption of grapefruit, grapefruit juice or grapefruit-related citrus fruits (e.g. Seville oranges, pomelos) within 14 days prior to the first dose of study drug
- Use of prescription or non-prescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study drug. With the exception of paracetamol (which may be used incidentally or for a short-term treatment at a maximum dose of 2 g per day) and hormone replacement therapy
- Use of herbal supplements within 30 days prior to the first dose of study drug
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or HIV-1 or HIV-2 antibody results
- Clinically significant abnormal biochemistry, hematology or urinalysis as judged by the PI. In case of doubt the PI will discuss this with the medical monitor
- Positive urine drug screen result at screening or admission to the clinical research center
- 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 >100 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 = 250 mL beer, 25 mL of 40% spirit or 125 mL of wine)
- Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the PI or delegate at screening
- Failure to satisfy the PI of fitness to participate for any other reason
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
PRA Health Sciences (PRA) - Early Development Services (EDS)
Groningen, 9728
About this study
Official title: An Open-label, Two-part Study to Determine the Absolute Bioavailability (BA) of OZ439 Using Simultaneous Intravenous [14C]-OZ439 Microdose/800mg Oral Dosing and to Investigate the Pharmacokinetics (PK) of OZ439 Granules Administered as Single Doses Suspended in Different Volumes and When Co-administered With a Single Dose of Cobicistat, a Strong CYP3A4 Inhibitor, to Healthy Subjects in Fasted State
This study is an open-label, two-part study to determine the absolute bioavailability (BA) of OZ439 using simultaneous intravenous [14C]-OZ439 microdose/800mg oral dosing and to investigate the pharmacokinetics (PK) of OZ439 granules administered as single doses suspended in different volumes and when co-administered with a single dose of Cobicistat, a strong CYP3A4 inhibitor, to healthy subjects in fasted state.
Read the detailed description
Primary objectives of this study are:
- to determine the absolute bioavailability of OZ439 following a single oral dose of OZ439 dispersion and a simultaneous single intravenous (iv) microdose (100 μg) infusion of [14C]-OZ439 under fasted conditions (Part 1)
- To evaluate the effects of a single oral dose of cobicistat, a strong cytochrome P450 (CYP) 3A4 inhibitor, on the pharmacokinetic (PK) profile of a single oral dose of a dispersion of OZ439 simple granules under fasted conditions (Part 2)
- To evaluate the PK of single doses of OZ439 granules when restricting the target dosing volumes to 64.5 or 100 mL (Parts 1 and 2)
Secondary objectives are:
- To assess the safety and tolerability of OZ439 when administered alone, and to assess the safety and tolerability of OZ439 and cobicistat when co-administered as single doses to healthy subjects (Parts 1 and 2)
- To determine the PK parameters of OZ439 single iv microdose (100 μg) infusion of [14C]-OZ439 (Part 1)
- To assess the effects of the total dosing volume and of dose to volume ratio on OZ439 PK under fasted conditions (Parts 1 and 2)
- To determine the PK parameters and exposures of cobicistat (Part 2)
- Conditions
- Malaria
- Being tested
- Single oral dose of 800 mg OZ439, Single oral dose of 400 mg OZ439, Single oral dose of cobicistat, iv infusion of [14C]-OZ439
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single oral dose of 800 mg OZ439Drug
Single oral dose of 800 mg OZ439
Single oral dose of 400 mg OZ439Drug
Single oral dose of 400 mg OZ439
Single oral dose of cobicistatDrug
Single oral dose of 150 mg cobicistat
iv infusion of [14C]-OZ439Drug
15-minute 10-mL iv infusion of 100 μg [14C]-OZ439
| Study group | Role | What they receive |
|---|---|---|
| Part 1, single arm | Experimental | This was an open-label study in 8 healthy subjects to determine the absolute bioavailability of OZ439 following a single oral dose of OZ439 and co-administration of a single iv infusion of a [14C]-OZ439 radiolabeled microdose at the anticipated Tmax of the oral dose. Subjects received the following treatment:
Treatment A: A single oral dose of 800 mg OZ439 simple granules administered as a 100-mL dispersion followed by a 15-minute 10-mL iv infusion of 100 μg [14C]-OZ439 (47 kBq [1.27 μCi]) beginning 3 hours after the oral dose administration. Receives: Drug: Single oral dose of 800 mg OZ439; Drug: iv infusion of [14C]-OZ439 |
| Part 2, Treatment B: single oral dose of 800 mg OZ439 | Experimental | This was an open-label, randomized, single-dose, 3-way cross-over study in 18 healthy subjects. Each subject participated in 3 treatment periods and each subject received a single dose of each of the following 3 treatments in a randomized order with a 14-day wash-out period between each treatment: Treatment B: A single oral dose of 800 mg OZ439 simple granules administered as a 64.5-mL dispersion Treatment C: A single oral dose of 400 mg OZ439 simple granules administered as a 64.5-mL dispersion Treatment D: A single oral dose of 400 mg OZ439 simple granules administered as a 64.5-mL dispersion and co-administered with a 150 mg cobicistat tablet (CYP3A4 inhibitor) Receives: Drug: Single oral dose of 800 mg OZ439 |
| Part 2, Treatment C: single oral dose of 400 mg OZ439 | Experimental | This was an open-label, randomized, single-dose, 3-way cross-over study in 18 healthy subjects. Each subject participated in 3 treatment periods and each subject received a single dose of each of the following 3 treatments in a randomized order with a 14-day wash-out period between each treatment: Treatment B: A single oral dose of 800 mg OZ439 simple granules administered as a 64.5-mL dispersion Treatment C: A single oral dose of 400 mg OZ439 simple granules administered as a 64.5-mL dispersion Treatment D: A single oral dose of 400 mg OZ439 simple granules administered as a 64.5-mL dispersion and co-administered with a 150 mg cobicistat tablet (CYP3A4 inhibitor) Receives: Drug: Single oral dose of 400 mg OZ439 |
| Part 2, Treatment D:single oral dose 400 mg OZ439+cobicistat | Experimental | This was an open-label, randomized, single-dose, 3-way cross-over study in 18 healthy subjects. Each subject participated in 3 treatment periods and each subject received a single dose of each of the following 3 treatments in a randomized order with a 14-day wash-out period between each treatment: Treatment B: A single oral dose of 800 mg OZ439 simple granules administered as a 64.5-mL dispersion Treatment C: A single oral dose of 400 mg OZ439 simple granules administered as a 64.5-mL dispersion Treatment D: A single oral dose of 400 mg OZ439 simple granules administered as a 64.5-mL dispersion and co-administered with a 150 mg cobicistat tablet (CYP3A4 inhibitor) Receives: Drug: Single oral dose of 400 mg OZ439; Drug: Single oral dose of cobicistat |
What is being measured
The primary outcome is the main question the study is designed to answer.
OZ439 Fpo
OZ439 Absolute oral bioavailability
Measured: OZ439: Pre-dose, 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96, 168 hours post-dose. [14C]-OZ439: 10, 15, 20, 30 and 45 minutes after start of iv infusion then 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96, 168 hours
OZ439 Cmax
OZ439 maximum concentration observed
Measured: Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96, 168, 216, 264, 312 hours post-dose
OZ439 C168h
OZ439 concentration observed at 168h
Measured: 168 hours post-dose
OZ439 AUC0-168h
Area under the OZ439 plasma concentration time curve from time zero to 168h
Measured: Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96, 168 hours post-dose
OZ439 AUC0-inf
Area under the OZ439 plasma concentration time curve from time zero to infinity
Measured: Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96, 168, 216, 264, 312 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start28 Feb 2017
- Primary completion30 May 2017
- Study completion30 May 2017
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
- Crossover
- Model description
- Part1: Open label, one treatment Part 2: Open-label, randomized, single-dose, 3-way cross-over study
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicines for Malaria Venture
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04069221
- Sponsor's protocol ID
- MMV_OZ439_16_01
- Status last verified
- Nov 2019
- First submitted
- 22 Aug 2019
- Last updated
- 26 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Two-part Study to Determine the Absolute Bioavailability (BA) of OZ439 Using Simultaneous Intravenous [14C]-OZ439 Microdose/800mg Oral Dosing and to Investigate the Pharmacokinetics (PK) of OZ439 Granules Administered as Single Doses Suspended in Different Volumes and When Co-administered With a Single Dose of Cobicistat, a Strong CYP3A4 Inhibitor, to Healthy Subjects in Fasted State
- ClinicalTrials.gov ID
- NCT04069221
- Acronym / sponsor ID
- MMV_OZ439_16_01
- Conditions
- Malaria
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Medicines for Malaria VentureUniversity, hospital or other
- Study start
- 28 Feb 2017 (actual)
- Primary completion
- 30 May 2017 (actual)
- Study completion
- 30 May 2017 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Posted 26 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is an open-label, two-part study to determine the absolute bioavailability (BA) of OZ439 using simultaneous intravenous [14C]-OZ439 microdose/800mg oral dosing and to investigate the pharmacokinetics (PK) of OZ439 granules administered as single doses suspended in different volumes and when co-administered with a single dose of Cobicistat, a strong CYP3A4 inhibitor, to healthy subjects in fasted state.
Detailed description
Primary objectives of this study are:
- to determine the absolute bioavailability of OZ439 following a single oral dose of OZ439 dispersion and a simultaneous single intravenous (iv) microdose (100 μg) infusion of [14C]-OZ439 under fasted conditions (Part 1)
- To evaluate the effects of a single oral dose of cobicistat, a strong cytochrome P450 (CYP) 3A4 inhibitor, on the pharmacokinetic (PK) profile of a single oral dose of a dispersion of OZ439 simple granules under fasted conditions (Part 2)
- To evaluate the PK of single doses of OZ439 granules when restricting the target dosing volumes to 64.5 or 100 mL (Parts 1 and 2)
Secondary objectives are:
- To assess the safety and tolerability of OZ439 when administered alone, and to assess the safety and tolerability of OZ439 and cobicistat when co-administered as single doses to healthy subjects (Parts 1 and 2)
- To determine the PK parameters of OZ439 single iv microdose (100 μg) infusion of [14C]-OZ439 (Part 1)
- To assess the effects of the total dosing volume and of dose to volume ratio on OZ439 PK under fasted conditions (Parts 1 and 2)
- To determine the PK parameters and exposures of cobicistat (Part 2)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Part1: Open label, one treatment Part 2: Open-label, randomized, single-dose, 3-way cross-over study
| Arm | Type | Receives |
|---|---|---|
| Part 1, single arm | Experimental | Drug: Single oral dose of 800 mg OZ439, Drug: iv infusion of [14C]-OZ439This was an open-label study in 8 healthy subjects to determine the absolute bioavailability of OZ439 following a single oral dose of OZ439 and co-administration of a single iv infusion of a [14C]-OZ439 radiolabeled microdose at the anticipated Tmax of the oral dose. Subjects received the following treatment: Treatment A: A single oral dose of 800 mg OZ439 simple granules administered as a 100-mL dispersion followed by a 15-minute 10-mL iv infusion of 100 μg [14C]-OZ439 (47 kBq [1.27 μCi]) beginning 3 hours after the oral dose administration. |
| Part 2, Treatment B: single oral dose of 800 mg OZ439 | Experimental | Drug: Single oral dose of 800 mg OZ439This was an open-label, randomized, single-dose, 3-way cross-over study in 18 healthy subjects. Each subject participated in 3 treatment periods and each subject received a single dose of each of the following 3 treatments in a randomized order with a 14-day wash-out period between each treatment: Treatment B: A single oral dose of 800 mg OZ439 simple granules administered as a 64.5-mL dispersion Treatment C: A single oral dose of 400 mg OZ439 simple granules administered as a 64.5-mL dispersion Treatment D: A single oral dose of 400 mg OZ439 simple granules administered as a 64.5-mL dispersion and co-administered with a 150 mg cobicistat tablet (CYP3A4 inhibitor) |
| Part 2, Treatment C: single oral dose of 400 mg OZ439 | Experimental | Drug: Single oral dose of 400 mg OZ439This was an open-label, randomized, single-dose, 3-way cross-over study in 18 healthy subjects. Each subject participated in 3 treatment periods and each subject received a single dose of each of the following 3 treatments in a randomized order with a 14-day wash-out period between each treatment: Treatment B: A single oral dose of 800 mg OZ439 simple granules administered as a 64.5-mL dispersion Treatment C: A single oral dose of 400 mg OZ439 simple granules administered as a 64.5-mL dispersion Treatment D: A single oral dose of 400 mg OZ439 simple granules administered as a 64.5-mL dispersion and co-administered with a 150 mg cobicistat tablet (CYP3A4 inhibitor) |
| Part 2, Treatment D:single oral dose 400 mg OZ439+cobicistat | Experimental | Drug: Single oral dose of 400 mg OZ439, Drug: Single oral dose of cobicistatThis was an open-label, randomized, single-dose, 3-way cross-over study in 18 healthy subjects. Each subject participated in 3 treatment periods and each subject received a single dose of each of the following 3 treatments in a randomized order with a 14-day wash-out period between each treatment: Treatment B: A single oral dose of 800 mg OZ439 simple granules administered as a 64.5-mL dispersion Treatment C: A single oral dose of 400 mg OZ439 simple granules administered as a 64.5-mL dispersion Treatment D: A single oral dose of 400 mg OZ439 simple granules administered as a 64.5-mL dispersion and co-administered with a 150 mg cobicistat tablet (CYP3A4 inhibitor) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Body mass index (BMI) : 18.0-30.0 kg/m2, inclusive, at screening
- Weight : >50 kg, at screening
- Status : healthy subjects
- Female subjects must be of non-childbearing potential (either surgically sterilized or physiologically incapable of becoming pregnant, or post-menopausal [defined as spontaneous amenorrhoea for at least 1 year or spontaneous amenorrhoea for at least 6 months confirmed by a follicle stimulating hormone (FSH) result indicating a post-menopausal status]) and have a negative pregnancy test at screening and at (each) admission to the clinical research center. As all female subjects must be of non-childbearing potential, they are not required to use any contraception during this study.
- Male subjects must use adequate contraception and not donate sperm from (first) admission to the clinical research center until 90 days after the follow-up visit. Adequate contraception for the male subject (and his female partner) is defined as surgical sterilization (vasectomy), using hormonal contraceptives (implantable, patch, oral, injectable) or an intrauterine device or system combined with at least 1 of the following forms of contraception (barrier method): a diaphragm or cervical cap, or a condom. Also, total abstinence, in accordance with the lifestyle of the subject is acceptable.
Key exclusion criteria (27 listed)
- A subject who meets any of the following exclusion criteria will not be eligible for inclusion in the study:
- Male subjects who have currently pregnant partners or who have partners planning to be pregnant in the 90 days after discharge
- Evidence or history of clinically significant oncological, pulmonary, chronic respiratory, hepatic, cardiovascular, hematological, metabolic, neurological, immunological, nephrological, endocrine or psychiatric disease, or current infection
- Clinically relevant (as decided by the Principal Investigator [PI]) abnormalities in the 12-lead ECG, 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
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 |
|---|---|---|
| Single oral dose of 800 mg OZ439Single oral dose of 800 mg OZ439 | Drug | Part 1, single arm, Part 2, Treatment B: single oral dose of 800 mg OZ439 |
| Single oral dose of 400 mg OZ439Single oral dose of 400 mg OZ439 | Drug | Part 2, Treatment C: single oral dose of 400 mg OZ439, Part 2, Treatment D:single oral dose 400 mg OZ439+cobicistat |
| Single oral dose of cobicistatSingle oral dose of 150 mg cobicistat | Drug | Part 2, Treatment D:single oral dose 400 mg OZ439+cobicistat |
| iv infusion of [14C]-OZ43915-minute 10-mL iv infusion of 100 μg [14C]-OZ439 | Drug | Part 1, single arm |
Primary outcome
OZ439 Fpo
Time frame: OZ439: Pre-dose, 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96, 168 hours post-dose. [14C]-OZ439: 10, 15, 20, 30 and 45 minutes after start of iv infusion then 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96, 168 hours
OZ439 Absolute oral bioavailability
OZ439 Cmax
Time frame: Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96, 168, 216, 264, 312 hours post-dose
OZ439 maximum concentration observed
OZ439 C168h
Time frame: 168 hours post-dose
OZ439 concentration observed at 168h
OZ439 AUC0-168h
Time frame: Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96, 168 hours post-dose
Area under the OZ439 plasma concentration time curve from time zero to 168h
OZ439 AUC0-inf
Time frame: Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96, 168, 216, 264, 312 hours post-dose
Area under the OZ439 plasma concentration time curve from time zero to infinity
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Single oral dose of 800 mg OZ439, Single oral dose of 400 mg OZ439 and Single oral dose of cobicistat in people with Malaria, run by Medicines for Malaria Venture at 1 site in Netherlands.
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 9 inclusion and 27 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 26 Nov 2019. 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 Netherlands. 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 26 Nov 2019). 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 Fpo (time frame: OZ439: Pre-dose, 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96, 168 hours post-dose. [14C]-OZ439: 10, 15, 20, 30 and 45 minutes after start of iv infusion then 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96, 168 hours). The study lists 5 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 26 Nov 2019.