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- Klinische proef NCT01660022
Safety Tolerability & Pharmacokinetics of Co-administered Single Doses of OZ439 & Piperaquine to Healthy Subjects
A Phase I Study to Investigate the Safety, Tolerability & Pharmacokinetics of Co-administered Single Doses of OZ439 and Piperaquine to Healthy Subjects
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
- Geneesmiddel: Placebo
- Geneesmiddel: 100mg OZ439 single oral dose
- Geneesmiddel: 160mg Piperaquine single oral dose
- Geneesmiddel: 480mg Piperaquine single oral dose
- Geneesmiddel: 1440mg Piperaquine single oral dose
- Geneesmiddel: 300 mg OZ439 single oral dose
- Geneesmiddel: 800 mg OZ439 single oral dose
Gedetailleerde beschrijving
Placebo-controlled, double-blind, five-cohort, 2-period (per cohort) dose-escalation study.
For each subject, the study included a screening evaluation (within 21 days of the 1st dose), dosing on 2 separate occasions (Period 1 and Period 2) and a follow-up visit (6 weeks following the final dose).
Within each cohort, subjects were randomised into two sequences to receive OZ439 in Period 1 and OZ439 plus piperaquine in Period 2 (sequence 1, 8 subjects) or OZ439-matching placebo in Period 1 and OZ439/piperaquine matching placebos in Period 2 (sequence 2, 4 subjects).
Safety and tolerability were evaluated: Physical examination, ECG assessments including a full baseline matched profile of ECG tracings, vital signs, laboratory evaluations, in particular liver function tests and adverse events.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
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Mendrisio, Zwitserland, CH 6850
- Cross Research S.A.
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Healthy males & females, 18-55 years old
- BMI 18 to 30kg/m2; total body weight >50kg
- Healthy, determined by pre-study medical history, physical examination vital signs, 12 Lead ECG
- Females of non-childbearing potential.
- Males must agree to use a double barrier method of contraception
- Lab tests at screening within the reference ranges
Exclusion Criteria:
- Any condition that could affect drug absorption, e.g. gastrectomy, diarrhea
- Clinically relevant abnormalities in ECG
- Family history of sudden death or of congenital prolongation of QTc interval - History of symptomatic cardiac arrhythmias or with clinically relevant bradycardia
- Electrolyte disturbances
- History of drug or alcohol abuse, tobacco users
- Participation in evaluation of any drug for 3 months before the study
- Administration of ANY systemic medication/herbal product within 14 days of first dose of study drug.
- unaccustomed strenuous exercise within 7 days of any study visit
- Alcohol consumption within 24 hours of any study visit
- Consumption of any fruit juice or food containing grapefruit within 7 days
- Positive test for HIV-1, HBsAg or HCV
- Positive urine drug screen at Screening or admission
- Severe allergies/multiple drug allergies
- Volunteers who have donated blood or experienced significant blood loss within 90 days of screening
- Hemoglobin below lower limit of the reference range
- Clinically relevant abnormal lab values indicative of physical illness
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Placebo-vergelijker: Placebo
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Placebo
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Experimenteel: OZ439 100mg
100mg OZ439 single oral dose
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100mg OZ439 oral suspension single dose
Andere namen:
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Experimenteel: OZ439 100 mg + PQP 160mg
100mg OZ439 single oral dose + 160mg Piperaquine single oral dose
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100mg OZ439 oral suspension single dose
Andere namen:
160 mg Piperaquine tablet
Andere namen:
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Experimenteel: OZ439 100 mg + PQP 480mg
100mg OZ439 single oral dose + 480mg Piperaquine single oral dose
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100mg OZ439 oral suspension single dose
Andere namen:
480 mg Piperaquine tablet
Andere namen:
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Experimenteel: OZ439 100 mg + PQP 1440mg
100mg OZ439 single oral dose + 1440mg Piperaquine single oral dose
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100mg OZ439 oral suspension single dose
Andere namen:
1440 mg Piperaquine tablet
Andere namen:
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Experimenteel: OZ439 300mg
300mg OZ439 single oral dose
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300mg OZ439 oral suspension single dose
Andere namen:
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Experimenteel: OZ439 300 mg + PQP 1440mg
300mg OZ439 single oral dose + 1440mg Piperaquine single oral dose
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1440 mg Piperaquine tablet
Andere namen:
300mg OZ439 oral suspension single dose
Andere namen:
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Experimenteel: OZ439 800mg
800mg OZ439 single oral dose
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800mg OZ439 oral suspension single dose
Andere namen:
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Experimenteel: OZ439 800 mg + PQP 1440mg
800mg OZ439 single oral dose + 1440mg Piperaquine single oral dose
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1440 mg Piperaquine tablet
Andere namen:
800mg OZ439 oral suspension single dose
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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OZ439 Cmax
Tijdsspanne: Up to 168 hours post-dose
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OZ439 Maximum concentration level
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Up to 168 hours post-dose
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Piperaquine Cmax
Tijdsspanne: Up to 1008 hours post-dose (Day 43)
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Piperaquine Maximum concentration level
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Up to 1008 hours post-dose (Day 43)
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OZ439 AUC(0-168)
Tijdsspanne: Up to 168 hours post-dose
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Area under the plasma concentration versus time curve to 168 hours post-dose.
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Up to 168 hours post-dose
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OZ439 t1/2
Tijdsspanne: Up to 168 hours post-dose
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OZ439 Elimination half-life
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Up to 168 hours post-dose
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Piperaquine AUC(0-168)
Tijdsspanne: Up to 1008 hours post-dose (Day 43)
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Piperaquine area under the plasma concentration versus time curve to 168 hours post-dose
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Up to 1008 hours post-dose (Day 43)
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Piperaquine t1/2
Tijdsspanne: Up to 1008 hours post-dose (Day 43)
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Piperaquine Elimination half-life (t1/2).
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Up to 1008 hours post-dose (Day 43)
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Milko M Radicioni, MD PhD, Cross Research S.A.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- MMV_OZ439_12_002
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