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CompletedNCT00928083Updated Jan 8, 2015Results posted

A Study to Investigate the Safety, Tolerability and Pharmacokinetics of OZ439 in Healthy Male and Female Subjects

A Phase 1 interventional study of OZ439 50mg API capsules and OZ439 200mg API capsules in Malaria Falciparum, Malaria Vivax and Healthy Volunteers, sponsored by Medicines for Malaria Venture. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-01-08.

Sponsored by Medicines for Malaria Venture · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
63
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Malaria Falciparum
  • Malaria Vivax
  • Healthy Volunteers

Keywords

  • Phase I
  • Safety and tolerability
  • Pharmacokinetic
  • synthetic peroxide
  • trioxolane
  • treatment of erythrocytic stages of malaria
03

In context

Malaria

1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.

This study's enrollment of 63 is below the median of 220 across 1,027 interventional studies indexed under Malaria.

Browse Malaria studies →

Lead sponsor

Medicines for Malaria Venture is the lead sponsor of 66 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Healthy male//female subjects between 18- 55 years of age (inclusive).
  2. Body mass Index (BMI) between 18 - 30 kg/m2, inclusive; and a total body weight >60 kg (132 lbs).
  3. Healthy as determined by pre-study medical history, PE, 12 Lead ECG.

  4. Females of childbearing potential must use 1 of birth control methods throughout study and for 30 days after last dose of study drug:

    1. Surgically sterile (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) 6 months minimum prior to first dose of study drug.
    2. Intrauterine device (IUD) in place for at least 3 months prior to first dose of study drug.
    3. 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.
    4. Surgical sterilization of the partner(s) (vasectomy with zero sperm count for 6 months minimum prior to the first dose of study drug).
    5. 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.
  5. Post-menopausal women with amenorrhea for at least 1 year will be eligible confirmed by FSH.
  6. 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.
  7. Able/willing to give written informed consent.
  8. Willing/to adhere to lifestyle guideline restrictions outlined in protocol.
  9. Willing and able to be confined to Clinical Research Unit as required by the protocol.

Exclusion criteria

Exclusion Criteria:

  1. Evidence/history of clinically significant oncologic, pulmonary, hepatic, cardiovascular, hematologic, metabolic, neurological, immunologic, nephrologic, endocrine, psychiatric disease, current infection.
  2. Evidence/history of clinically significant gastrointestinal (some exclusions exist) disease, current infection.
  3. Any condition that affecting drug absorption, e.g., gastrectomy.
  4. History of post-antibiotic colitis.
  5. Breast feeding.
  6. QTc greater than 450 msec for males and 470 msec for females as corrected by the Bazett formula.
  7. History of drug or alcohol abuse within the past 2 years prior to Screening.
  8. Tobacco users
  9. Received investigational drug/ participated in another research study within 30 days of first dose of study drug in any part of study.
  10. 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.
  11. 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)
  12. 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).
  13. 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.
  14. Positive serum pregnancy test at the Screening Visit or on Day -1 prior to inclusion in any part of the study.
  15. Positive test for HIV-1, HBsAg,HCV.
  16. Positive urine drug screen at Screening or admission to CRU.
  17. History of intolerance/ hypersensitivity to artemisinins.
  18. Likelihood of requiring treatment during study period with drugs not permitted by protocol.
  19. Subjects who have donated blood or experienced significant blood loss within 60 days of screening for study.
  20. Subjects whose hemoglobin is \<12.5 g/dL for males/ \<11.5 g/dL for females.
  21. 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
63 participants (actual)

Study arms

  • Experimental
    Part A - 50 mg Single Dose

    OZ439 Single doses of 50mg (capsules)

    Drug: OZ439 50mg API capsules

  • Experimental
    Part A - 100mg Single Dose

    OZ439 Single doses of 100mg (capsules)

    Drug: OZ439 100mg API capsules

  • Experimental
    Part A - 200mg Single Dose

    OZ439 Single doses of 200mg (capsules)

    Drug: OZ439 200mg API capsules

  • Experimental
    Part A - 400mg Single Dose

    OZ439 Single doses of 400mg (capsules)

    Drug: OZ439 400mg API capsules

  • Experimental
    Part A - 400mg Single Dose + Food

    OZ439 Single doses of 400mg (capsules) administered with food.

    Drug: OZ439 400mg API capsules

  • Experimental
    Part A - 400mg AD Single Dose

    OZ439 Single doses of 400mg (aqueous dispersion)

    Drug: OZ439 400mg aqueous dispersion

  • Experimental
    Part A - 800mg Single Dose

    OZ439 Single doses of 800mg (capsules)

    Drug: OZ439 800mg API capsules

  • Experimental
    Part A - 800mg AD Single Dose

    OZ439 Single doses of 800mg (aqueous dispersion)

    Drug: OZ439 800mg aqueous dispersion

  • Experimental
    Part A - 1200mg Single Dose

    OZ439 Single doses of 1200mg (capsules)

    Drug: OZ439 1200mg API capsules

  • Experimental
    Part A - 1600mg AD Single Dose

    OZ439 Single doses of 800mg (aqueous dispersion)

    Drug: OZ439 1600mg aqueous dispersion

  • Placebo comparator
    Part A - Placebo

    Placebo control for Single rising Part A

    Drug: Placebo

  • Experimental
    Part B - 800mg AD Single Dose Fed

    Single dose of OZ439 800mg aqueous dispersion administered under fed conditions

    Drug: OZ439 800mg aqueous dispersion

  • Experimental
    Part B - 800mg AD Single Dose Fast

    Single dose of OZ439 800mg aqueous dispersion administered under fast conditions

    Drug: OZ439 800mg aqueous dispersion

  • Experimental
    Part C - 200mg AD Multiple Dose

    200mg aqueous solution OZ439 or placebo once daily for 3 days fasted

    Drug: OZ439 200mg aqueous dispersion

  • Experimental
    Part C - 400mg AD Multiple Dose

    400mg aqueous solution OZ439 or placebo once daily for 3 days fasted

    Drug: OZ439 400mg aqueous dispersion

  • Experimental
    Part C - 800mg AD Multiple Dose

    800mg aqueous solution OZ439 or placebo once daily for 3 days fasted

    Drug: OZ439 800mg aqueous dispersion

  • Placebo comparator
    Part C - Placebo

    Placebo control for Multiple rising Part C

    Drug: Placebo

Interventions

  • DrugOZ439 50mg API capsules

    Also known as: OZ439

  • DrugOZ439 200mg API capsules

    Also known as: OZ439

  • DrugOZ439 400mg aqueous dispersion
  • DrugOZ439 800mg aqueous dispersion

    Also known as: OZ439

  • DrugOZ439 100mg API capsules

    OZ439 100mg (2x50mg API capsules)

    Also known as: OZ439

  • DrugOZ439 400mg API capsules

    OZ439 400mg (2x200mg API capsules)

    Also known as: OZ439

  • DrugOZ439 1600mg aqueous dispersion

    Also known as: OZ439

  • DrugOZ439 800mg API capsules

    OZ439 800mg (4x200 API capsules)

    Also known as: OZ439

  • DrugOZ439 1200mg API capsules

    OZ439 1200mg (6x200mg API capsules)

    Also known as: OZ439

  • DrugPlacebo
  • DrugOZ439 200mg aqueous dispersion

    Also known as: OZ439

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From screening and at 10 (+/-2) days after last dose of study medication

Secondary outcomes

  1. 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).

    Time frame: Samples collected from Pre-dose up to 96h post dose

  2. OZ439 AUC0-∝

    Area under the plasma concentration-time curve from zero to infinity (AUC0-∝).

    Time frame: Samples collected from Pre-dose up to 96h post dose

  3. OZ439 Cmax

    Maximum observed plasma drug concentration (Cmax).

    Time frame: Samples collected from Pre-dose up to 96h post dose

  4. OZ439 Tmax

    Time to maximum observed plasma drug concentration of OZ439

    Time frame: Samples collected from Pre-dose up to 96h post dose

  5. OZ439 t1/2

    Apparent terminal half-life (t1/2)

    Time frame: Samples collected from Pre-dose up to 96h post dose

  6. 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)

    Time frame: Samples collected from Pre-dose up to 96h post dose

07

Results

Posted Jan 8, 2015

Participant flow

Participant flow — Overall Study
MilestonePart A - OZ439 Single Dose - Cohort 1Part A - OZ439 Single Dose - Cohort 2Part A - OZ439 Single Dose - Cohort 3Part B - Food Effect - Cohort 1Part B - Food Effect - Cohort 2Part C - 200mg OZ439 Multiple DosePart C - 400mg OZ439 Multiple DosePart C - 800mg OZ439 Multiple DosePart C - Placebo
Started1088676666
Completed688566666
Not completed400110000

Outcome measures

PrimaryAdverse 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.

Time frame:
From screening and at 10 (+/-2) days after last dose of study medication
Reported as:
Number · participants
Adverse Events
participantsPart A - 50 mg Single DosePart A - 100mg Single DosePart A - 200mg Single DosePart A - 400mg Single DosePart A - 400mg Single Dose + FoodPart A - 400mg AD Single DosePart A - 800mg Single DosePart A - 800mg AD Single DosePart A - 1200mg Single DosePart A - 1600mg AD Single DosePart A - PlaceboPart B - 800mg AD Single Dose FedPart B - 800mg AD Single Dose FastPart C - 200mg AD Multiple DosePart C - 400mg AD Multiple DosePart C - 800mg AD Multiple DosePart C - Placebo
Adverse Events10200121154343140
SecondaryOZ439 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).

Time frame:
Samples collected from Pre-dose up to 96h post dose
Reported as:
Geometric mean · ng.h/ml
OZ439 AUC0-t
ng.h/mlPart A - 50 mg Single DosePart A - 100mg Single DosePart A - 200mg Single DosePart A - 400mg Single DosePart A - 400mg AD Single DosePart A - 800mg Single DosePart A - 800mg AD Single DosePart A - 1200mg Single DosePart A - 1600mg AD Single DosePart B - 800mg AD Single Dose FedPart B - 800mg AD Single Dose FastPart C - 200mg AD Multiple DosePart C - 400mg AD Multiple DosePart C - 800mg AD Multiple Dose
OZ439 AUC0-t102 ± 133.7249 ± 145.4890 ± 89.11130 ± 186.65430 ± 723010 ± 115.79630 ± 56.96530 ± 172.417500 ± 70.123100 ± 48.97590 ± 64.73060 ± 60.17990 ± 57.513700 ± 46.0
SecondaryOZ439 AUC0-∝

Area under the plasma concentration-time curve from zero to infinity (AUC0-∝).

Time frame:
Samples collected from Pre-dose up to 96h post dose
Reported as:
Geometric mean · ng.h/ml
OZ439 AUC0-∝
ng.h/mlPart A - 50 mg Single DosePart A - 100mg Single DosePart A - 200mg Single DosePart A - 400mg Single DosePart A - 400mg AD Single DosePart A - 800mg Single DosePart A - 800mg AD Single DosePart A - 1200mg Single DosePart A - 1600mg AD Single DosePart B - 800mg AD Single Dose FedPart B - 800mg AD Single Dose FastPart C - 200mg AD Multiple DosePart C - 400mg AD Multiple DosePart C - 800mg AD Multiple Dose
OZ439 AUC0-∝NA ± NANA ± NANA ± NANA ± NA5540 ± 71.34690 ± 43.59790 ± 56.79130 ± 136.818400 ± 6823900 ± 498080 ± 68.7NA ± NANA ± NANA ± NA
SecondaryOZ439 Cmax

Maximum observed plasma drug concentration (Cmax).

Time frame:
Samples collected from Pre-dose up to 96h post dose
Reported as:
Geometric mean · ng/ml
OZ439 Cmax
ng/mlPart A - 50 mg Single DosePart A - 100mg Single DosePart A - 200mg Single DosePart A - 400mg Single DosePart A - 400mg AD Single DosePart A - 800mg Single DosePart A - 800mg AD Single DosePart A - 1200mg Single DosePart A - 1600mg AD Single DosePart B - 800mg AD Single Dose FedPart B - 800mg AD Single Dose FastPart C - 200mg AD Multiple DosePart C - 400mg AD Multiple DosePart C - 800mg AD Multiple Dose
OZ439 Cmax17.4 ± 84.734.2 ± 173.5102 ± 82.9135 ± 164.9566 ± 53.9315 ± 121.8917 ± 35.6701 ± 154.71340 ± 44.52220 ± 52.6730 ± 61.1342 ± 52.5764 ± 46.61390 ± 51.7
SecondaryOZ439 Tmax

Time to maximum observed plasma drug concentration of OZ439

Time frame:
Samples collected from Pre-dose up to 96h post dose
Reported as:
Median · hours
OZ439 Tmax
hoursPart A - 50 mg Single DosePart A - 100mg Single DosePart A - 200mg Single DosePart A - 400mg Single DosePart A - 400mg AD Single DosePart A - 800mg Single DosePart A - 800mg AD Single DosePart A - 1200mg Single DosePart A - 1600mg AD Single DosePart B - 800mg AD Single Dose FedPart B - 800mg AD Single Dose FastPart C - 200mg AD Multiple DosePart C - 400mg AD Multiple DosePart C - 800mg AD Multiple Dose
OZ439 Tmax3 (2 to 6)5 (3 to 12)3.5 (3 to 6)3 (2 to 6)3 (2 to 4)3 (2 to 4)3 (3 to 6)3 (2 to 6)5 (2 to 6)5 (2 to 7)3 (2 to 5)3 (2 to 5)3 (2 to 5)3 (2 to 5)
SecondaryOZ439 t1/2

Apparent terminal half-life (t1/2)

Time frame:
Samples collected from Pre-dose up to 96h post dose
Reported as:
Geometric mean · hours
OZ439 t1/2
hoursPart A - 50 mg Single DosePart A - 100mg Single DosePart A - 200mg Single DosePart A - 400mg Single DosePart A - 400mg AD Single DosePart A - 800mg Single DosePart A - 800mg AD Single DosePart A - 1200mg Single DosePart A - 1600mg AD Single DosePart B - 800mg AD Single Dose FedPart B - 800mg AD Single Dose FastPart C - 200mg AD Multiple DosePart C - 400mg AD Multiple DosePart C - 800mg AD Multiple Dose
OZ439 t1/2NA ± NANA ± NANA ± NANA ± NA31.2 ± 33.527.9 ± 24.125.2 ± 25.831.6 ± 46.930.7 ± 41.931.7 ± 30.138.8 ± 50.241.7 ± 18.240.8 ± 31.437.8 ± 28.6
SecondaryOZ439 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)

Time frame:
Samples collected from Pre-dose up to 96h post dose
Reported as:
Geometric mean · ratio
OZ439 Rac
ratioPart C - 200mg AD Multiple DosePart C - 400mg AD Multiple DosePart C - 800mg AD Multiple Dose
OZ439 Rac1.16 ± 18.71.76 ± 29.91.43 ± 26.0

Adverse events

Collected over Adverse event monitoring throughout the admission period.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Part A - 50 mg Single Dose—0/8 (0%)1/8 (12.5%)
Part A - 100mg Single Dose—0/8 (0%)0/8 (0%)
Part A - 200mg Single Dose—0/8 (0%)2/8 (25%)
Part A - 400mg Single Dose—0/7 (0%)0/7 (0%)
Part A - 400mg Single Dose + Food—0/6 (0%)0/6 (0%)
Part A - 400mg AD Single Dose—0/5 (0%)1/5 (20%)
Part A - 800mg Single Dose—0/8 (0%)2/8 (25%)
Part A - 800mg AD Single Dose—0/6 (0%)1/6 (16.7%)
Part A - 1200mg Single Dose—0/6 (0%)1/6 (16.7%)
Part A - 1600mg AD Single Dose—0/6 (0%)5/6 (83.3%)
Part A - Placebo—1/17 (5.9%)4/17 (23.5%)
Part B - 800mg AD Single Dose Fed—0/12 (0%)3/12 (25%)
Part B - 800mg AD Single Dose Fast—0/12 (0%)4/12 (33.3%)
Part C - 200mg AD Multiple Dose—0/6 (0%)3/6 (50%)
Part C - 400mg AD Multiple Dose—0/6 (0%)1/6 (16.7%)
Part C - 800mg AD Multiple Dose—0/6 (0%)4/6 (66.7%)
Part C - Placebo—0/6 (0%)0/6 (0%)
Most frequent serious events
Most frequent serious events
EventPart A - 50 mg Single DosePart A - 100mg Single DosePart A - 200mg Single DosePart A - 400mg Single DosePart A - 400mg Single Dose + FoodPart A - 400mg AD Single DosePart A - 800mg Single DosePart A - 800mg AD Single DosePart A - 1200mg Single DosePart A - 1600mg AD Single DosePart A - PlaceboPart B - 800mg AD Single Dose FedPart B - 800mg AD Single Dose FastPart C - 200mg AD Multiple DosePart C - 400mg AD Multiple DosePart C - 800mg AD Multiple DosePart C - Placebo
InfluenzaRespiratory, thoracic and mediastinal disorders0/80/80/80/70/60/50/80/60/60/61/170/120/120/60/60/60/6
Most frequent other events
Showing 10 of 27
Most frequent other events
EventPart A - 50 mg Single DosePart A - 100mg Single DosePart A - 200mg Single DosePart A - 400mg Single DosePart A - 400mg Single Dose + FoodPart A - 400mg AD Single DosePart A - 800mg Single DosePart A - 800mg AD Single DosePart A - 1200mg Single DosePart A - 1600mg AD Single DosePart A - PlaceboPart B - 800mg AD Single Dose FedPart B - 800mg AD Single Dose FastPart C - 200mg AD Multiple DosePart C - 400mg AD Multiple DosePart C - 800mg AD Multiple DosePart C - Placebo
DiarrhoeaGastrointestinal disorders0/80/80/80/70/60/50/80/60/63/60/170/120/120/60/61/60/6
NauseaGastrointestinal disorders0/80/80/80/70/60/50/80/60/63/60/170/121/121/60/61/60/6
Gastrointestinal HypermotilityGastrointestinal disorders0/80/80/80/70/60/50/80/60/62/60/170/120/120/60/60/60/6
HeadacheNervous system disorders0/80/81/80/70/60/50/80/61/60/61/172/121/122/60/60/60/6
FlushingVascular disorders0/80/80/80/70/60/50/80/60/60/60/170/120/120/60/62/60/6
ConstipationGastrointestinal disorders0/80/80/80/70/61/50/81/60/61/61/170/120/120/60/60/60/6
Abdominal DisconfortGastrointestinal disorders0/80/80/80/70/60/50/80/60/61/60/170/120/120/60/60/60/6
Throat IrritationGastrointestinal disorders0/80/80/80/70/60/50/80/60/60/60/170/120/120/60/61/60/6
Blood Pressure IncreasedInvestigations0/80/80/80/70/60/50/80/60/60/60/170/120/121/60/60/60/6
Back PainMusculoskeletal and connective tissue disorders0/80/80/80/70/60/50/80/60/60/60/170/120/120/61/60/60/6

Baseline characteristics

Age, Continuous
Age, Continuous(years)Part A - OZ439 Single Rising DosePart B - OZ439 Food EffectPart C - OZ439 Multiple Rising DoseTotal
Mean35.6 ± 10.3533.7 ± 8.4940.1 ± 10.1736.5 ± 9.67
Sex: Female, Male
Sex: Female, Male(Participants)Part A - OZ439 Single Rising DosePart B - OZ439 Food EffectPart C - OZ439 Multiple Rising DoseTotal
Female59923
Male2141540
Region of Enrollment
Region of Enrollment(participants)Part A - OZ439 Single Rising DosePart B - OZ439 Food EffectPart C - OZ439 Multiple Rising DoseTotal
United States26132463
08

Study locations

1 site
  • Comprehensive Phase One Miramar; 3400 Enterprise Way
    Miramar, Florida 33025, United States
09

References and documents

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 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 8, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00928083
Lead sponsor
Medicines for Malaria Venture
Responsible party
Sponsor
First posted
Jun 25, 2009
Start date
Apr 2009
Primary completion
Oct 2009
Completion
Dec 2009
Results posted
Jan 8, 2015
Last update
Jan 8, 2015

Study contacts

Joerg Moehrle, PhD
study director · Medicines for Malaria Venture
Maria Gutierrez, MD
principal investigator · Comprehensive Phase One Miramar, 3400 Enterprise Way, Miramar, FL 33025

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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