Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2025-12-25 @ 1:03 AM
NCT ID:
NCT01841593
Eligibility Criteria:
Inclusion Criteria:
Subjects must meet all of the following inclusion criteria within 28 days prior to the baseline visit:
* 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
* Male or non-pregnant, non-lactating females
* Between 18 to 65 years, inclusive
* Body Mass Index (BMI) of 18 to 35 kg/m2, inclusive.
* Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 12 weeks after the study
* Willing to consent to their personal details being entered onto The Over-volunteering Prevention Scheme (TOPS) database
* Willing to provide photographic identification at each visit.
* Registered with a GP in the UK
Exclusion Criteria:
Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.
* Any significant acute or chronic medical illness including hypertension (BP persistently \>140/90 mmHg) or hypotension (BP persistently \<90/60 mmHg)
* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations
* Positive blood screen for hepatitis B surface antigen and/or C antibodies
* Positive blood screen for HIV-1 and/or 2 antibodies
* Current or recent (within 3 months) gastrointestinal disease
* Clinically relevant alcohol or drug use (positive urine drug screen) or history of alcohol or drug use considered by the Investigator to be sufficient to hinder compliance with treatment, follow-up procedures or evaluation of adverse events. Smoking is permitted, but tobacco intake should remain consistent throughout the study
* Exposure to any investigational drug or placebo within 3 months of first dose of study drug
* Use of any other drugs (unless approved by the Investigator), including over-the-counter medications and herbal preparations, within two weeks prior to first dose of study drug, unless approved/prescribed by the Principal Investigator as known not to interact with study drugs.
* Females of childbearing potential without the use of effective non-hormonal birth control methods, or not willing to continue practising these birth control methods for at least 12 weeks after the end of the treatment period
* Previous allergy to any of the constituents of the pharmaceuticals administered in this trial
* Lactose intolerance
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01841593
Study Brief:
Protocol Section:
NCT01841593