A comparative assessment of two lumefantrine formulations compared to the standard reference formulation in healthy male and female volunteers of non-childbearing potential.
- Conditions
- MalariaInfection - Other infectious diseases
- Registration Number
- ACTRN12618000968279
- Lead Sponsor
- ovartis Pharmaceuticals Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 42
Written informed consent must be obtained prior to participation in the study.
Healthy male and female subjects of non-childbearing potential aged 18 to 55 years included, and in good health as determined by past medical history, physical examination, vital signs, ECG, and laboratory tests at Screening.
At Screening, vital signs (systolic and diastolic blood pressure and
pulse rate) will be assessed in the sitting position after the subject has rested for at least 5 minutes, and again after 3 minutes in the standing position at Screening only. Sitting vital signs will be captured for the duration of the study and should be within the normal range:
-oral body temperature between 35.0°C to 37.5°C
-systolic blood pressure, 90 to 139 mmHg
-diastolic blood pressure, 40 to 89 mmHg
-pulse rate, 40 to 90 bpm
Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 to 30 kg/m2. BMI = body weight (kg)/(height [m])2.
Able to communicate well with the Investigator, to understand and
comply with the requirements of the study.
Women of childbearing potential, defined as all women physiologically capable of becoming pregnant. Women are considered postmenopausal and not of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least 6 weeks ago. In the case of oophorectomy alone, a woman will only be considered not of childbearing potential if her reproductive status has been confirmed by follow-up hormone level assessment.
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin laboratory test.
Sexually active males unwilling to use a condom during intercourse or unwilling to refrain from sperm donation for greater than or equal to 4 weeks (28 days) after last dosing. A condom is required for all sexually active male participants to prevent them from either fathering a child OR donating sperms.
Use of any prescription drugs or over-the-counter medication (vitamins, herbal supplements, and dietary supplements) within 4 weeks or 5 times the terminal half-life of each drug prior to dosing.
Use of other investigational drugs at the time of enrollment, or within
30 days, whichever is longer; or longer if required by local regulations.
History of hypersensitivity to the study drug or any of its excipients or to drugs of similar chemical classes.
A past medical history of clinically significant cardiac or ECG
abnormalities (including arrhythmias) or a family history (grandparents, parents and siblings) of a prolonged QT interval syndrome, defined as a corrected QT interval, by Fridericia formula of > 450 msec of males and > 460 msec for females at Screening or first Baseline.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method