Phase 1
Completed N=59
Safety Tolerability & Pharmacokinetics of Co-administered Single Doses of OZ439 & Piperaquine to Healthy Subjects
Healthy
Source: ClinicalTrials.gov NCT01660022 ↗
Enrolled (actual)
59
Serious AEs
1.1%
Results posted
Jan 2015
Primary outcomePrimary: OZ439 Cmax — 142; 139; 146; 198 ng/mL
Summary
A Phase I Study to investigate the safety, tolerability & pharmacokinetics of co-administered single doses of OZ439 and Piperaquine to healthy subjects.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY OZ439 Cmax |
142; 139; 146; 198; 127; 199 | — |
| PRIMARY Piperaquine Cmax |
8.59; 46.6; 393; 271; 356 | — |
| PRIMARY OZ439 AUC(0-168) |
862; 920; 1130; 1390; 909; 1520 | — |
| PRIMARY OZ439 t1/2 |
NA; NA; NA; NA; NA; NA | — |
| PRIMARY Piperaquine AUC(0-168) |
1340; 3420; 17500; 17200; 13200 | — |
| PRIMARY Piperaquine t1/2 |
294; 283; 515; 632; 509 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01660022). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.