Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2016-03-31
2017-05-31
Brief Summary
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The study will be conducted into two sequential parts (Cohort 1 and Cohorts 2a and 2b).
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Detailed Description
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* Controlled human malaria infection on Day 0 (Direct Venous Inoculation of 3200 cryopreserved Plasmodium falciparum sporozoites)
* Drug administration on Day -3
* 8 subjects: 6 DSM265 400 mg: 2 matching placebo Clinical safety review of Cohort 1 in order to proceed to Cohorts 2a and 2b
Cohort 2a:
* Controlled human malaria infection on Day 0 (Direct Venous Inoculation of 3200 cryopreserved Plasmodium falciparum sporozoites)
* Drug administration on Day -X (to be defined following safety and pharmacokinetic data)
* 8 subjects: 6 DSM265 400 mg: 2 matching placebo
Cohort 2b:
* Controlled human malaria infection on Day 0 (infected mosquito bite)
* Drug administration on Day -X (to be defined following safety and pharmacokinetic data)
* 8 subjects: 6 DSM265 400 mg: 2 matching placebo
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Cohort 1 Active DSM265
DSM265
DSM265 400 mg single oral dose
Sporozoites
Direct venous inoculation of 3200 cryopreserved Plasmodium falciparum (NF54 strain) sporozoites
Cohort 1 Placebo
Placebo
Placebo to match DSM265, single oral dose
Sporozoites
Direct venous inoculation of 3200 cryopreserved Plasmodium falciparum (NF54 strain) sporozoites
Cohort 2a Active DSM265
DSM265
DSM265 400 mg single oral dose
Sporozoites
Direct venous inoculation of 3200 cryopreserved Plasmodium falciparum (NF54 strain) sporozoites
Cohort 2a Placebo
Placebo
Placebo to match DSM265, single oral dose
Sporozoites
Direct venous inoculation of 3200 cryopreserved Plasmodium falciparum (NF54 strain) sporozoites
Cohort 2b Active DSM265
DSM265
DSM265 400 mg single oral dose
Infective mosquito bite
Five single bites by laboratory reared female Anopheles stephensi mosquitoes carrying Plasmodium falciparum
Cohort 2b Placebo
Placebo
Placebo to match DSM265, single oral dose
Infective mosquito bite
Five single bites by laboratory reared female Anopheles stephensi mosquitoes carrying Plasmodium falciparum
Interventions
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DSM265
DSM265 400 mg single oral dose
Placebo
Placebo to match DSM265, single oral dose
Sporozoites
Direct venous inoculation of 3200 cryopreserved Plasmodium falciparum (NF54 strain) sporozoites
Infective mosquito bite
Five single bites by laboratory reared female Anopheles stephensi mosquitoes carrying Plasmodium falciparum
Other Intervention Names
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Eligibility Criteria
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Exclusion Criteria
* Plans to travel to malaria endemic region during the study period
* Previous participation in any malaria vaccine study or controlled human malaria infection study
* Participation in any other clinical study within 30 days of enrollment or plan to participate in another investigational vaccine/drug research during the study
* Breastfeeding or planning to become pregnant during the time of the study
* Positive Human Immunodeficiency Virus, Hepatitis B or C tests
* Any confirmed/suspected immunosuppressive or immunodeficient state
* History of serious psychiatric condition that may affect participation in the study, or history of convulsions, seizures, or of severe head trauma
* Symptoms, physical signs or laboratory values suggestive of systemic disorders
* History of cancer (except basal cell carcinoma of the skin)
* History of arrhythmias or documented prolonged QTcF-interval (\>450 msec) or 12-lead ECG demonstrating specific abnormalities
* Moderate risk or higher for cardiovascular event within 5 years (\>10%)
* Positive family history in 1st or 2nd degree relative \<50 years for cardiac disease, or history of, or known active cardiac disease
* history of: psoriasis or porphyria which may be exacerbated by chloroquine; splenectomy, or sickle cell anaemia or other red blood cell disorders; allergy or contra-indication to chloroquine or atovaquone-proguanil
* Treatment with an investigational drug within 28 days or 5 half-lives of study medication; use of any drugs or dietary supplements within 7 days or 5 half-lives prior to study medication. Herbal supplements must be discontinued at least 28 days prior to study medication. As an exception, acetaminophen or ibuprofen may be used as approved by the investigator
* Use of any prohibited medication
* Grapefruit or product containing grapefruit from28 days before study medication or throughout the study
* History of drug or alcohol abuse within 12 months prior to dosing, or laboratory evidence of abuse
* Current smoking of more than 10 cigarettes or equivalent per day
* Plan for major surgery between enrolment and study completion
18 Years
45 Years
ALL
Yes
Sponsors
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Fred Hutchinson Cancer Center
OTHER
United States Department of Defense
FED
Center for Infectious Disease Research
UNKNOWN
Medicines for Malaria Venture
OTHER
Responsible Party
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Principal Investigators
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James G Kublin, MD/MPH
Role: PRINCIPAL_INVESTIGATOR
Fred Hutchinson Cancer Research Centre
Locations
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Fred Hutchinson Cancer Research Center - Prevention Center
Seattle, Washington, United States
Countries
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Other Identifiers
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CDMRP-PR130402
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
MMV_DSM265_14_03
Identifier Type: -
Identifier Source: org_study_id
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