A Randomized SAD and MAD Study Evaluating the Safety and Tolerability of RPh201 in Healthy Subjec… (NCT01513967) | Clinical Trial Compass
CompletedPhase 1/2
A Randomized SAD and MAD Study Evaluating the Safety and Tolerability of RPh201 in Healthy Subjects and in Adults With Alzheimer's Disease
Canada39 participantsStarted 2012-01
Plain-language summary
This is a dual-centre, Phase I/IIa study, in healthy subjects and subjects with AD to investigate the safety, tolerability, cognitive, and behavioural effects of RPh201. The study will be divided into three parts: A, B, and C (NOT Performed)
Who can participate
Age range18 Years
SexALL
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For PART A AND PART B (healthy volunteers, SAD and MAD)
Inclusion Criteria:
* healthy male or female subjects 18 to 65 years of age, inclusive
* body mass index (BMI) within the range of 18.0 to 33.0 kg/m2, inclusive, and a minimum weight of at least 50.0 kg at Screening
* female subjects of childbearing potential must be practicing abstinence or using and willing to continue using two medically acceptable form of birth control for at least 1 month prior to Screening (at least 3 months for oral and transdermal contraceptives) and for at least 1 month after the last study drug administration. Medically acceptable forms of contraception include oral or patch hormonal contraceptives, intrauterine device, progestin implant or injection, bilateral tubal ligation, or double-barrier (i.e., male condom in addition to a diaphragm or a contraceptive sponge).
* female subjects of non-childbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy/salpingo-oophorectomy (as determined by subject medical history)
* male subjects of reproductive potential with a partner(s) of childbearing potential, must be using and willing to continue to using two medically acceptable contraceptive precautions from Screening and for at least 1 month after the last study drug administration. Medically acceptable forms of contraception include abstinence, vasectomy, or male condom for subjects
* female subjects must have a negative pregnancy test
* able …
What they're measuring
1
The Primary Objective: to Evaluate the Safety and Tolerability of RPh201 After Single and Multiple Rising Doses.