Overview
The Effect of Antacids and Multivitamins on Raltegravir
Status:
Completed
Completed
Trial end date:
2016-02-01
2016-02-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
This study seeks to address the question of whether antacids or multivitamins influence the pharmacokinetics of raltegravir when co-administered. The aim of this study is to optimise the dosing of raltegravir when co-administered with antacids or multivitamins.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Helen ReynoldsTreatments:
Aluminum hydroxide, magnesium hydroxide, drug combination
Aluminum hydroxide, magnesium hydroxide, simethicone drug combination
Antacids
Raltegravir Potassium
TEMPO
Criteria
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