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:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2025-12-24 @ 3:56 PM
NCT ID:
NCT01529892
Eligibility Criteria:
Inclusion Criteria:
1. The subject is healthy, as judged by a responsible physician, with no clinically significant abnormality identified on the laboratory or medical evaluation, including 12-lead ECG, at screening. A subject with a clinical laboratory or laboratory parameter outside the reference range (adjusted for age, if appropriate), may be included only if the Investigator considers that the abnormal finding does not pose additional risk and will not interfere with the study procedures.
2. Male or female, aged 18-55 years inclusive
3. Body weight over 50kg (110 lbs) and body mass index (BMI) of 18.5 to 30 kg/m2 inclusive.
4. Have normal cardiac function including normal blood pressure and heart rate.
5. Have normal renal function as evident by a creatinine clearance \>70 ml/min and normal serum creatinine levels
6. The subject is capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Exclusion Criteria:
1. A positive urine test for drugs of abuse or alcohol at screening or prior to the start of dosing.
2. Subjects with a clinical history of current alcohol or illicit drug use which, in the opinion of the investigator, would interfere with the subject's ability to comply with the dosing schedule and protocol-specified evaluations.
3. Active Psychiatric disease: DSM-IV diagnosis of a current alcohol, opiate, or sedative hypnotic dependence disorder requiring medical detoxification, history of decompensated schizophrenia, schizophreniform, or schizoaffective disorder; Severe mania, hypomania, agitated behaviour, bipolar disorder or post-traumatic stress disorder within the past 90 days; presence of suicidal behavior two years prior to enrolment or suicidal intent within the past 30 days.
4. The subject has received an investigational drug or participated in any other research trial within 30 days, 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of current study medication.
5. Use of any prescription or non-prescription drugs, vitamins, herbal and dietary supplements within seven days (or 14 days if the drug is a potential CYP2D6 enzyme inhibitor) or 5 half-lives (whichever is longer) prior to the first dose of study mediation, unless, in the opinion of the Investigator and sponsor, the medication will not interfere with the study procedures or compromise subject safety.
6. Subjects with a pre-existing condition interfering with normal gastrointestinal anatomy or motility, hepatic and/or renal function, that could interfere with the absorption, metabolism, and/or excretion of the study drugs. Examples of conditions that could interfere with normal gastrointestinal anatomy or motility include gastrointestinal bypass surgery, partial or total gastrectomy, small bowel resection, vagotomy, malabsorption, Crohn's disease, ulcerative colitis, intestinal or urinary obstruction, or celiac sprue.
7. History of hypersensitivity to amphetamine-type drugs, or history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation.
8. Pregnancy or fertile women without adequate means of contraception.
9. Any other medical or psychosocial condition that would preclude useful, safe or consistent participation.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01529892
Study Brief:
Protocol Section:
NCT01529892