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Phase 1 Completed N=59 Randomized Quadruple-blind Basic Science

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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