Healthy VolunteersPhase 1NCT01383096

Study To Investigate The Relative Bioavailability of OZ439 Formulations In Healthy Volunteers

A Phase 1 study testing OZ439 mesylate 800mg Powder in Bottle for Oral Suspension, OZ439 mesylate 400mg Prototype Solution Formula 1 and OZ439 mesylate 800mg Prototype Solution Formula 1 in people with Healthy Volunteers, run by Medicines for Malaria Venture at 1 site in Australia.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: OZ439 mesylate 800mg Powder in Bottle for Oral Suspension, OZ439 mesylate 400mg Prototype Solution Formula 1 and OZ439 mesylate 800mg Prototype Solution Formula 1
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: 1 siteAustralia
Study dates: Apr 2012to Aug 2012
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 female volunteers between 18 and 55 years (inclusive). Post-menopausal women with amenorrhoea for at least 2 years are eligible confirmed by FSH level >/ = 25microlU/ml
Body mass Index between 18 and 30 kg/m2, inclusive; and body weight > 50 kg.
Healthy as determined by pre-study medical history, physical examination (including body temperature), 12 Lead ECG.
Male volunteers must agree to use a double barrier method of contraception including abstinence, condom plus diaphragm or condom plus IUD or condom plus stable oral/transdermal/injectable hormonal contraceptive by female partner for at least 14 days prior to the time of the first dose of study drug through 90 days after the last dose of study drug and must also agree to not donate sperm for 90 days after the last dose of study drug. Vasectomy with zero sperm count for 6 months minimum prior to the first dose of study drug is an acceptable form of contraception
Clinical laboratory tests at screening within the reference ranges or if outside the normal range not clinically significant. ALT, AST and total bilirubin must be within the normal range
Able and willing to give written informed consent
Willing and able to adhere to the lifestyle guideline requirements
Willing and able to be confined to the Clinical Research Unit as required by the protocol

Who cannot join

Evidence of or history of clinically significant oncologic, pulmonary, hepatic, cardiovascular, hematologic, metabolic, neurological, immunologic, nephrologic, endocrine, psychiatric disease, or current infection
Evidence of or history of clinically significant gastrointestinal (excluding appendectomy and cholecystectomy) disease or current infection.
Any condition that could possibly affect drug absorption, e.g. gastrectomy, diarrhea
History of post-antibiotic colitis
Pregnancy or breastfeeding
QTc greater than 450 msec for males and females as corrected by the Fredricia's formula or evidence or history of abnormal cardiac rhythm

Show all 20Show fewer

History of drug or alcohol abuse within the past 2 years prior to Screening
Tobacco users (includes stopping smoking less than 90 days prior to screening. "Tobacco use" includes smoking and the use of snuff and chewing tobacco, and other nicotine containing products
Received an investigational drug or participated in another research study within 30 days of the first dose of study drug in any part of the 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 the study
Received any non prescription medications, vitamins, herbal supplements or dietary supplements within 7 days of the first dose of study drug in Period 1, unless prior approval is granted. Excluded from this list is intermittent use of acetaminophen at doses of up to 2 g/day
Consumed alcohol within 72 hours of Day -1 in any part of the study, or have a positive alcohol screen at screening or each admission
Consumed fruit juice or ate grapefruit within 7 days prior to the first dose of study drug in any part of the study
Positive test for human immunodeficiency virus, hepatitis B surface antigen or anti-hepatitis C virus
Positive urine drug screen at Screening or admission
History of intolerance or hypersensitivity to artemisinins
Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol
Volunteers who have donated blood or experienced significant blood loss within 90 days of screening
Hemoglobin < 13.5 g/dL for males and < 12.5 g/dL for females
Any concern by the investigator regarding the safe participation of the volunteer or any reason the investigator considers the volunteer inappropriate for participation

Trial locations and contacts

1 site in 1 country.

Australia1 site

AMREP Centre for Clinical Studies
Melbourne, Victoria, VIC 3004

Other trials in Australia

About this study

Official title: A Phase I Study To Investigate The Relative Bioavailability of OZ439 Formulations In Healthy Volunteers

This study is designed to assess prototype formulations compared to the aqueous dispersion of Active Pharmaceutical Ingredient used in Phase I and Phase IIa studies to date. It is hoped that the bioavailability of OZ439 can be enhanced in the fasted state to be close to that observed when given after food. This will improve the utility of OZ439 in the field as well as decreasing the cost of treatment (by decreasing the dose of OZ439 required) which is very important for an antimalarial drug product destined for use in developing counties.

Read the detailed description

This study was a single centre, open-label, pharmacokinetic, randomized cross-over study in healthy male volunteers and post-menopausal women. This study was conducted over three different cohorts as follows:

Cohort 1: Subjects received a single 800 mg (as free base) dose of five different treatment regimes (treatments A, B, C, D and E) on five occasions.

Cohort 2: Subjects received a single 800 mg (as free base) dose of four different treatment regimes (treatments F, G, H and I) on four occasions.

Cohort 3: Subjects received a single dose, 800mg (as free base) of prototype solution formulation 1 (treatment J) and 400mg (as free base) of prototype solution formulation 1 (treatment K) on two occasions. The treatments were administered under the fasted state.

Conditions: Healthy Volunteers
Being tested: OZ439 mesylate 800mg Powder in Bottle for Oral Suspension, OZ439 mesylate 400mg Prototype Solution Formula 1, OZ439 mesylate 800mg Prototype Solution Formula 1, OZ439 mesylate 800mg Prototype Solution Formula 2
Keywords: OZ439, Bioavailability, Food Effect

What participants receive

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

OZ439 mesylate 800mg Powder in Bottle for Oral SuspensionDrug
Also called OZ439 PIB
OZ439 800 mg (as free base) as powder in a bottle for reconstitution in a suspension prior to oral administration
OZ439 mesylate 400mg Prototype Solution Formula 1Drug
Also called OZ439 400mg Prototype 1
OZ439 400 mg (as free base) as a prototype solution formulation 1
OZ439 mesylate 800mg Prototype Solution Formula 1Drug
Also called OZ439 800mg Prototype 1
OZ439 800 mg (as free base) as a prototype solution formulation 1
OZ439 mesylate 800mg Prototype Solution Formula 2Drug
Also called OZ439 800mg Prototype 2
OZ439 800 mg (as free base) as a prototype solution formulation 2

Study groups in NCT01383096
Study group	Role	What they receive
Cohort 1 - Treatment A: OZ439 800mg PIB, fed	Active comparator	OZ439 800 mg (as free base) as powder in a bottle (PIB)for reconstitution in a suspension prior to administration. Administered 30 minutes after a standard fatty breakfast. Receives: Drug: OZ439 mesylate 800mg Powder in Bottle for Oral Suspension
Cohort 1 - Treatment D: OZ439 800 mg Prototype F1 fasted	Experimental	OZ439 800 mg (as free base) as a prototype solution formulation 1. Administered fasted. Receives: Drug: OZ439 mesylate 800mg Prototype Solution Formula 1
Cohort 2 - Treatement H: OZ439 800 mg Prototype F2 fasted	Experimental	OZ439 800 mg (as free base) as a prototype solution formulation 2. Administered fasted. Receives: Drug: OZ439 mesylate 800mg Prototype Solution Formula 2
Cohort 3 - Treatement K: OZ439 400mg Prototype F1 fasted	Experimental	Best Prototype Solution - OZ439 400 mg as prototype solution formulation 1. Administered fasted. Receives: Drug: OZ439 mesylate 400mg Prototype Solution Formula 1
Cohort 1 - Treatement B: OZ439 800mg PIB fasted	Experimental	OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered fasted. Receives: Drug: OZ439 mesylate 800mg Powder in Bottle for Oral Suspension
Cohort 1 - Treatment C:OZ439 800mg PIB with milk	Experimental	OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered following 200 mL milk. Receives: Drug: OZ439 mesylate 800mg Powder in Bottle for Oral Suspension
Cohort 3 - Treatment J: OZ439 800mg Prototype F1 fasted	Experimental	Best Prototype Solution - OZ439 800 mg (as free base) as prototype solution formulation 1. Administered fasted. Receives: Drug: OZ439 mesylate 800mg Prototype Solution Formula 1
Cohort 1 - Treatement E: OZ439 800mg Prototype F1 with milk	Experimental	OZ439 800 mg (as free base) as a prototype solution formulation 1. Administered with milk. Receives: Drug: OZ439 mesylate 800mg Prototype Solution Formula 1
Cohort 2 - Treatement F: OZ439 800 mg PIB fasted	Experimental	OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered fasted. Receives: Drug: OZ439 mesylate 800mg Powder in Bottle for Oral Suspension
Cohort 2 - Treatement G: OZ439 800mg PIB with milk	Experimental	OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered following 200 mL milk. Receives: Drug: OZ439 mesylate 800mg Powder in Bottle for Oral Suspension
Cohort 2 - Treatement I: OZ349 800mg Prototype F2 with milk	Experimental	OZ439 800 mg (as free base) as a prototype solution formulation 2. Administered with milk. Receives: Drug: OZ439 mesylate 800mg Prototype Solution Formula 2

What is being measured

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

OZ439 Cmax
The maximum observed plasma drug concentrations (Cmax)
Measured: 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post dosing
OZ439 AUC0-∞
Area under the plasma concentration-time curve from zero to infinity (AUC0-∞)
Measured: 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post dosing
OZ439 t1/2
Apparent terminal half life (t1/2)
Measured: 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post dosing

Timeline

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

Apr 2012Aug 2012

First posted28 Jun 2011 (estimated)
Study startApr 2012
Primary completionAug 2012
Study completionAug 2012

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 Healthy VolunteersStudies 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: None (open label)
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01383096
Sponsor's protocol ID: MMV_OZ439_11_001
Status last verified: Jan 2015
First submitted: 23 Jun 2011
Last updated: 29 Jan 2015
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?

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Study at a glance

From the registry record, last updated by the sponsor on 29 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Study To Investigate The Relative Bioavailability of OZ439 Formulations In Healthy Volunteers
ClinicalTrials.gov ID: NCT01383096
Acronym / sponsor ID: MMV_OZ439_11_001
Conditions: Healthy Volunteers
Keywords: OZ439, Bioavailability, Food Effect
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: Medicines for Malaria VentureUniversity, hospital or other
Collaborators: Nucleus Network Ltd, Syneos Health
Study start: Apr 2012
Primary completion: Aug 2012 (actual)
Study completion: Aug 2012 (actual)
First posted: 28 Jun 2011 (estimated)
Results: Posted 29 Jan 2015

Clinical summary

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

Detailed description

Cohort 1: Subjects received a single 800 mg (as free base) dose of five different treatment regimes (treatments A, B, C, D and E) on five occasions.

Cohort 2: Subjects received a single 800 mg (as free base) dose of four different treatment regimes (treatments F, G, H and I) on four occasions.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 11

Arm	Type	Receives
Cohort 1 - Treatment A: OZ439 800mg PIB, fed	Active comparator	Drug: OZ439 mesylate 800mg Powder in Bottle for Oral SuspensionOZ439 800 mg (as free base) as powder in a bottle (PIB)for reconstitution in a suspension prior to administration. Administered 30 minutes after a standard fatty breakfast.
Cohort 1 - Treatment D: OZ439 800 mg Prototype F1 fasted	Experimental	Drug: OZ439 mesylate 800mg Prototype Solution Formula 1OZ439 800 mg (as free base) as a prototype solution formulation 1. Administered fasted.
Cohort 2 - Treatement H: OZ439 800 mg Prototype F2 fasted	Experimental	Drug: OZ439 mesylate 800mg Prototype Solution Formula 2OZ439 800 mg (as free base) as a prototype solution formulation 2. Administered fasted.
Cohort 3 - Treatement K: OZ439 400mg Prototype F1 fasted	Experimental	Drug: OZ439 mesylate 400mg Prototype Solution Formula 1Best Prototype Solution - OZ439 400 mg as prototype solution formulation 1. Administered fasted.
Cohort 1 - Treatement B: OZ439 800mg PIB fasted	Experimental	Drug: OZ439 mesylate 800mg Powder in Bottle for Oral SuspensionOZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered fasted.
Cohort 1 - Treatment C:OZ439 800mg PIB with milk	Experimental	Drug: OZ439 mesylate 800mg Powder in Bottle for Oral SuspensionOZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered following 200 mL milk.
Cohort 3 - Treatment J: OZ439 800mg Prototype F1 fasted	Experimental	Drug: OZ439 mesylate 800mg Prototype Solution Formula 1Best Prototype Solution - OZ439 800 mg (as free base) as prototype solution formulation 1. Administered fasted.
Cohort 1 - Treatement E: OZ439 800mg Prototype F1 with milk	Experimental	Drug: OZ439 mesylate 800mg Prototype Solution Formula 1OZ439 800 mg (as free base) as a prototype solution formulation 1. Administered with milk.
Cohort 2 - Treatement F: OZ439 800 mg PIB fasted	Experimental	Drug: OZ439 mesylate 800mg Powder in Bottle for Oral SuspensionOZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered fasted.
Cohort 2 - Treatement G: OZ439 800mg PIB with milk	Experimental	Drug: OZ439 mesylate 800mg Powder in Bottle for Oral SuspensionOZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered following 200 mL milk.
Cohort 2 - Treatement I: OZ349 800mg Prototype F2 with milk	Experimental	Drug: OZ439 mesylate 800mg Prototype Solution Formula 2OZ439 800 mg (as free base) as a prototype solution formulation 2. Administered with milk.

Who may qualify

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

Key inclusion criteria (8 listed)

Healthy male and female volunteers between 18 and 55 years (inclusive). Post-menopausal women with amenorrhoea for at least 2 years are eligible confirmed by FSH level >/ = 25microlU/ml
Body mass Index between 18 and 30 kg/m2, inclusive; and body weight > 50 kg.
Healthy as determined by pre-study medical history, physical examination (including body temperature), 12 Lead ECG.
Male volunteers must agree to use a double barrier method of contraception including abstinence, condom plus diaphragm or condom plus IUD or condom plus stable oral/transdermal/injectable hormonal contraceptive by female partner for at least 14 days prior to the time of the first dose of study drug through 90 days after the last dose of study drug and must also agree to not donate sperm for 90 days after the last dose of study drug. Vasectomy with zero sperm count for 6 months minimum prior to the first dose of study drug is an acceptable form of contraception
Clinical laboratory tests at screening within the reference ranges or if outside the normal range not clinically significant. ALT, AST and total bilirubin must be within the normal range

Key exclusion criteria (20 listed)

Evidence of or history of clinically significant oncologic, pulmonary, hepatic, cardiovascular, hematologic, metabolic, neurological, immunologic, nephrologic, endocrine, psychiatric disease, or current infection
Evidence of or history of clinically significant gastrointestinal (excluding appendectomy and cholecystectomy) disease or current infection.
Any condition that could possibly affect drug absorption, e.g. gastrectomy, diarrhea
History of post-antibiotic colitis
Pregnancy or breastfeeding

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 mesylate 800mg Powder in Bottle for Oral SuspensionAlso: OZ439 PIBOZ439 800 mg (as free base) as powder in a bottle for reconstitution in a suspension prior to oral administration	Drug	Cohort 1 - Treatement B: OZ439 800mg PIB fasted, Cohort 1 - Treatment A: OZ439 800mg PIB, fed, Cohort 1 - Treatment C:OZ439 800mg PIB with milk, Cohort 2 - Treatement F: OZ439 800 mg PIB fasted, Cohort 2 - Treatement G: OZ439 800mg PIB with milk
OZ439 mesylate 400mg Prototype Solution Formula 1Also: OZ439 400mg Prototype 1OZ439 400 mg (as free base) as a prototype solution formulation 1	Drug	Cohort 3 - Treatement K: OZ439 400mg Prototype F1 fasted
OZ439 mesylate 800mg Prototype Solution Formula 1Also: OZ439 800mg Prototype 1OZ439 800 mg (as free base) as a prototype solution formulation 1	Drug	Cohort 1 - Treatement E: OZ439 800mg Prototype F1 with milk, Cohort 1 - Treatment D: OZ439 800 mg Prototype F1 fasted, Cohort 3 - Treatment J: OZ439 800mg Prototype F1 fasted
OZ439 mesylate 800mg Prototype Solution Formula 2Also: OZ439 800mg Prototype 2OZ439 800 mg (as free base) as a prototype solution formulation 2	Drug	Cohort 2 - Treatement H: OZ439 800 mg Prototype F2 fasted, Cohort 2 - Treatement I: OZ349 800mg Prototype F2 with milk

Primary outcome

OZ439 Cmax
Time frame: 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post dosing
The maximum observed plasma drug concentrations (Cmax)
OZ439 AUC0-∞
Time frame: 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post dosing
Area under the plasma concentration-time curve from zero to infinity (AUC0-∞)
OZ439 t1/2
Time frame: 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post dosing
Apparent terminal half life (t1/2)

Results and safety

Results posted to the registry on 29 Jan 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1	19	19
Cohort 2	17	17
Cohort 3	16	16

Primary outcome: OZ439 Cmax

Time frame: 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post dosing. Geometric mean (Geometric Coefficient of Variation). Unit: ng/ml

Measure	Cohort 1 - Treatment A: OZ439 800mg PIB Fed n = 12	Cohort 1 - Treatment B: OZ439 800mg PIB Fasted n = 12	Cohort 1 - Treatment:OZ439 800mg PIB With Milk n = 12	Cohort 1 - Treatment D: OZ439 800 mg Prototype F1 Fasted n = 12	Cohort 1 - Treatment E: OZ439 800mg Prototype F1 With Milk n = 12	Cohort 2 - Treatment F: OZ439 800 mg PIB Fasted n = 12	Cohort 2 - Treatment G: OZ439 800mg PIB With Milk n = 12	Cohort 2 - Treatment H: OZ439 800 mg Prototype F2 Fasted n = 12	Cohort 2 - Treatment I: OZ349 800mg Prototype F2 With Milk n = 12	Cohort 3 - Treatment J: OZ439 800mg Prototype F1 Fasted n = 14	Cohort 3 - Treatment K: OZ439 400mg Prototype F1 Fasted n = 14
Value	1910 (32.9)	827 (47.7)	1930 (27.4)	1440 (46.2)	1830 (25.9)	538 (33.2)	1530 (31.2)	846 (44.9)	1680 (36.2)	1160 (35.8)	719 (29.0)

Population analysed: Pharmacokinetic Population: all subjects who received study drug, and completed at least one treatment (provided they had adequate OZ439 plasma concentration data) were included in the pharmacokinetic analysis.

Primary outcome: OZ439 AUC0-∞

Time frame: 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post dosing. Geometric mean (Geometric Coefficient of Variation). Unit: ng.h/mL

Measure	Cohort 1 - Treatement A: OZ439 800mg PIB Fed n = 11	Cohort 1 - Treatement B: OZ439 800mg PIB Fasted n = 12	Cohort 1 - Treatment C:OZ439 800mg PIB With Milk n = 11	Cohort 1 - Treatement D: OZ439 800 mg Prototype F1 Fasted n = 11	Cohort 1 - Treatement E: OZ439 800mg Prototype F1 With Milk n = 11	Cohort 2 - Treatement F: OZ439 800 mg PIB Fasted n = 10	Cohort 2 - Treatement G: OZ439 800mg PIB With Milk n = 12	Cohort 2 - Treatement H: OZ439 800 mg Prototype F2 Fasted n = 12	Cohort 2 - Treatement I: OZ349 800mg Prototype F2 With Milk n = 12	Cohort 3 - Treatement J: OZ439 800mg Prototype F1 Fasted n = 14	Cohort 3 - Treatement K: OZ439 400mg Prototype F1 Fasted n = 14
Value	29200 (31.2)	10700 (52.8)	24500 (44.0)	19000 (39.6)	25800 (26.9)	7460 (34.1)	21600 (33.0)	11700 (54.9)	22900 (41.9)	13800 (38.0)	7410 (33.3)

Primary outcome: OZ439 t1/2

Time frame: 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post dosing. Geometric mean (Geometric Coefficient of Variation). Unit: hours

Measure	Cohort 1 - Treatment A: OZ439 800mg PIB Fed n = 11	Cohort 1 - Treatment B: OZ439 800mg PIB Fasted n = 12	Cohort 1 - Treatment C: OZ439 800mg PIB With Milk n = 11	Cohort 1 - Treatment D: OZ439 800 mg Prototype F1 Fasted n = 11	Cohort 1 - Treatment E: OZ439 800mg Prototype F1 With Milk n = 11	Cohort 2 - Treatment F: OZ439 800 mg PIB Fasted n = 10	Cohort 2 - Treatment G: OZ439 800mg PIB With Milk n = 12	Cohort 2 - Treatment H: OZ439 800 mg Prototype F2 Fasted n = 12	Cohort 2 - Treatment I: OZ349 800mg Prototype F2 With Milk n = 12	Cohort 3 - Treatment J: OZ439 800mg Prototype F1 Fasted n = 14	Cohort 3 - Treatment K: OZ439 400mg Prototype F1 Fasted n = 14
Value	83.5 (27.8)	82.3 (46.9)	70.5 (45.9)	90.0 (26.0)	79.8 (27.2)	84.7 (27.3)	79.3 (28.0)	85.7 (22.0)	70.6 (17.7)	63.6 (14.7)	91.1 (35.7)

Adverse events

Time frame: Adverse event monitoring throughout the admission period.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1 - Treatment A: OZ439 800mg PIB Fed	0 of 17 (0%)	5 of 17 (29.4%)	Not reported
Cohort 1 - Treatment B: OZ439 800mg PIB Fasted	0 of 14 (0%)	5 of 14 (35.7%)	Not reported
Cohort 1 - Treatment C: OZ439 800mg PIB With Milk	0 of 15 (0%)	4 of 15 (26.7%)	Not reported
Cohort 1 - Treatment D: OZ439 800 mg Prototype F1 Fasted	0 of 17 (0%)	8 of 17 (47.1%)	Not reported
Cohort 1 - Treatment E: OZ439 800mg Prototype F1 With Milk	0 of 15 (0%)	9 of 15 (60%)	Not reported
Cohort 2 - Treatment F: OZ439 800 mg PIB Fasted	0 of 13 (0%)	5 of 13 (38.5%)	Not reported
Cohort 2 - Treatment G: OZ439 800mg PIB With Milk	0 of 15 (0%)	4 of 15 (26.7%)	Not reported
Cohort 2 - Treatment H: OZ439 800 mg Prototype F2 Fasted	0 of 17 (0%)	12 of 17 (70.6%)	Not reported
Cohort 2 - Treatment I: OZ349 800mg Prototype F2 With Milk	0 of 13 (0%)	5 of 13 (38.5%)	Not reported
Cohort 3 - Treatment J: OZ439 800mg Prototype F1 Fasted	0 of 14 (0%)	10 of 14 (71.4%)	Not reported
Cohort 3 - Treatment K: OZ439 400mg Prototype F1 Fasted	0 of 16 (0%)	4 of 16 (25%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 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.

Peter Peter Hodsman, MD principal investigator

AMREP Centre for Clinical Studies, Nucleus Network, 89 Commercial Road, Melbourne, VIC 3004 Australia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 20 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 29 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 Australia. 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 29 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?

OZ439 Cmax (time frame: 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post dosing). The study lists 3 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 NCT01383096.

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 29 Jan 2015.