- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 1
Kontakter och platser
Studieorter
-
-
-
Mendrisio, Schweiz, CH 6850
- Cross Research S.A.
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Placebo-jämförare: Placebo
|
Placebo
|
|
Experimentell: OZ439 100mg
100mg OZ439 single oral dose
|
100mg OZ439 oral suspension single dose
Andra namn:
|
|
Experimentell: OZ439 100 mg + PQP 160mg
100mg OZ439 single oral dose + 160mg Piperaquine single oral dose
|
100mg OZ439 oral suspension single dose
Andra namn:
160 mg Piperaquine tablet
Andra namn:
|
|
Experimentell: OZ439 100 mg + PQP 480mg
100mg OZ439 single oral dose + 480mg Piperaquine single oral dose
|
100mg OZ439 oral suspension single dose
Andra namn:
480 mg Piperaquine tablet
Andra namn:
|
|
Experimentell: OZ439 100 mg + PQP 1440mg
100mg OZ439 single oral dose + 1440mg Piperaquine single oral dose
|
100mg OZ439 oral suspension single dose
Andra namn:
1440 mg Piperaquine tablet
Andra namn:
|
|
Experimentell: OZ439 300mg
300mg OZ439 single oral dose
|
300mg OZ439 oral suspension single dose
Andra namn:
|
|
Experimentell: OZ439 300 mg + PQP 1440mg
300mg OZ439 single oral dose + 1440mg Piperaquine single oral dose
|
1440 mg Piperaquine tablet
Andra namn:
300mg OZ439 oral suspension single dose
Andra namn:
|
|
Experimentell: OZ439 800mg
800mg OZ439 single oral dose
|
800mg OZ439 oral suspension single dose
Andra namn:
|
|
Experimentell: OZ439 800 mg + PQP 1440mg
800mg OZ439 single oral dose + 1440mg Piperaquine single oral dose
|
1440 mg Piperaquine tablet
Andra namn:
800mg OZ439 oral suspension single dose
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
OZ439 Cmax
Tidsram: Up to 168 hours post-dose
|
OZ439 Maximum concentration level
|
Up to 168 hours post-dose
|
|
Piperaquine Cmax
Tidsram: Up to 1008 hours post-dose (Day 43)
|
Piperaquine Maximum concentration level
|
Up to 1008 hours post-dose (Day 43)
|
|
OZ439 AUC(0-168)
Tidsram: Up to 168 hours post-dose
|
Area under the plasma concentration versus time curve to 168 hours post-dose.
|
Up to 168 hours post-dose
|
|
OZ439 t1/2
Tidsram: Up to 168 hours post-dose
|
OZ439 Elimination half-life
|
Up to 168 hours post-dose
|
|
Piperaquine AUC(0-168)
Tidsram: Up to 1008 hours post-dose (Day 43)
|
Piperaquine area under the plasma concentration versus time curve to 168 hours post-dose
|
Up to 1008 hours post-dose (Day 43)
|
|
Piperaquine t1/2
Tidsram: Up to 1008 hours post-dose (Day 43)
|
Piperaquine Elimination half-life (t1/2).
|
Up to 1008 hours post-dose (Day 43)
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Milko M Radicioni, MD PhD, Cross Research S.A.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- MMV_OZ439_12_002
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