- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
-
-
-
Mendrisio, Sveits, CH 6850
- Cross Research S.A.
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Placebo komparator: Placebo
|
Placebo
|
|
Eksperimentell: OZ439 100mg
100mg OZ439 single oral dose
|
100mg OZ439 oral suspension single dose
Andre navn:
|
|
Eksperimentell: OZ439 100 mg + PQP 160mg
100mg OZ439 single oral dose + 160mg Piperaquine single oral dose
|
100mg OZ439 oral suspension single dose
Andre navn:
160 mg Piperaquine tablet
Andre navn:
|
|
Eksperimentell: OZ439 100 mg + PQP 480mg
100mg OZ439 single oral dose + 480mg Piperaquine single oral dose
|
100mg OZ439 oral suspension single dose
Andre navn:
480 mg Piperaquine tablet
Andre navn:
|
|
Eksperimentell: OZ439 100 mg + PQP 1440mg
100mg OZ439 single oral dose + 1440mg Piperaquine single oral dose
|
100mg OZ439 oral suspension single dose
Andre navn:
1440 mg Piperaquine tablet
Andre navn:
|
|
Eksperimentell: OZ439 300mg
300mg OZ439 single oral dose
|
300mg OZ439 oral suspension single dose
Andre navn:
|
|
Eksperimentell: OZ439 300 mg + PQP 1440mg
300mg OZ439 single oral dose + 1440mg Piperaquine single oral dose
|
1440 mg Piperaquine tablet
Andre navn:
300mg OZ439 oral suspension single dose
Andre navn:
|
|
Eksperimentell: OZ439 800mg
800mg OZ439 single oral dose
|
800mg OZ439 oral suspension single dose
Andre navn:
|
|
Eksperimentell: OZ439 800 mg + PQP 1440mg
800mg OZ439 single oral dose + 1440mg Piperaquine single oral dose
|
1440 mg Piperaquine tablet
Andre navn:
800mg OZ439 oral suspension single dose
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
OZ439 Cmax
Tidsramme: Up to 168 hours post-dose
|
OZ439 Maximum concentration level
|
Up to 168 hours post-dose
|
|
Piperaquine Cmax
Tidsramme: Up to 1008 hours post-dose (Day 43)
|
Piperaquine Maximum concentration level
|
Up to 1008 hours post-dose (Day 43)
|
|
OZ439 AUC(0-168)
Tidsramme: 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
Tidsramme: Up to 168 hours post-dose
|
OZ439 Elimination half-life
|
Up to 168 hours post-dose
|
|
Piperaquine AUC(0-168)
Tidsramme: 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
Tidsramme: Up to 1008 hours post-dose (Day 43)
|
Piperaquine Elimination half-life (t1/2).
|
Up to 1008 hours post-dose (Day 43)
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Milko M Radicioni, MD PhD, Cross Research S.A.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MMV_OZ439_12_002
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