About this trial
Last updated 9 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Trial Timing
Ended 9 years ago
What is this trial about?
What are the participation requirements?
Inclusion Criteria
- The ability to understand and sign a written informed consent form, prior to participation in any screening procedures and must be willing to comply with all study requirements.
- ≥ 18 years
- Male or female subjects
- A female may be eligible to enter and participate in the study if she:
- Is of non-child-bearing potential defined as ether post-menopausal (12 months of spontaneous amenorrhea and ≥ 45 years of age)or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or
- Is of child-bearing potential with a negative pregnancy test at screening and agrees to use one of the following methods of contraception to avoid pregnancy
- Complete abstinence from intercourse from 2 weeks prior to administration of IP, throughout the study and for at least 4 weeks after discontinuation of all study medication
- Double barrier method (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide)
- Any intrauterine device (IUD) with published data showing that the expected failure rate is < 1 % per year
- Any other method with published data showing that the expected failure rate is < 1 % per year
- Hormonal contraception plus a barrier method. Hormonal contraception alone will not be considered adequate for inclusion into or participation in this study
- Male subjects with a female partner of childbearing potential must agree to use effective contraception as above unless vasectomized
- All subjects participating in the study will be counseled on safer sexual practices including the use of effective barrier methods (e.g. male condom)
Exclusion Criteria
- Any significant acute or chronic medical condition
- Pregnant or lactating women
- Women of childbearing age unless using non hormonal contraception
- Evidence of organ dysfunction or any clinically significant deviation from normal during screening including laboratory determinations
- Abnormal LFTs (ALT > 2.5 x ULN, bilirubin > 1.5 x ULN)
- Positive blood screen for HIV-1 and 2 antibodies
- Positive blood screen for hepatitis B or C antibodies
- Current or recent (within 3 months) gastrointestinal disease
- Clinically relevant alcohol or drug use or history of alcohol or drug use that will hinder compliance with treatment, follow up procedures or evaluation of adverse effects
- Use of proton pump inhibitors
- Exposure to any investigational drug or placebo within 4 weeks of first dose of study drug
- Consumption of grapefruit and oranges or products containing grapefruit or oranges within 1 week of first study drug and for the duration of the study
- Use of any other drugs including over-the-counter medications and herbal preparations, within 2 weeks prior to first dose of study drug
- Previous allergy to any of the constituents of the pharmaceuticals in this trial