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 @ 2:16 PM
Ignite Modification Date:
2025-12-24 @ 2:16 PM
NCT ID:
NCT03220295
Eligibility Criteria:
Inclusion Criteria:
* Men and women aged 18 through 55 years, inclusive.
* Body mass index 18 through 32 kg/m2
* Determined as healthy based on screening medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG (QTc interval with Fridericia's correction method recorded on screening and predose must be less than 450 msec for male and less than 470 in females).
* Clinical laboratory test result without clinically significant abnormalities at screening and at admission.
* Negative tests for Hepatitis B surface antigen, hepatitis C virus antibodies and human immunodeficiency virus (HIV-1 or HIV-2) antibody at screening.
* Nonsmokers (use of any nicotine containing product) or ex-smokers (have ceased smoking for at least 6 months and do not use any drug for smoking cessation).
* Negative screen for alcohol and drugs of abuse at screening and admission.
* For Women: Must have no child-bearing potential by reason of surgery or at least 1 year post-menopausal (i.e. 12 months without menstrual period), or menopause confirmed with an estradiol level of \< 30 pg/mL and follicle-stimulating hormone level of \> 40 IU/L at screening.
* For Men: Must be infertile (at least 3-months post-vasectomy), or truly abstinent of heterosexual intercourse, or heterosexual partner is not of child-bearing potential, or must agree to use an effective method of contraception (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository) through the study and for 28 days after last dose of study drug.
* Able and willing to be available for the duration of the study.
* Willing and able to give written informed consent to participate.
* Able to understand and comply with protocol instructions.
* Agrees not to receive any vaccination within 21 days prior to admission and through Day 7 after final discharge.
* Agrees not to use nonprescription drugs, including vitamins, antacids, and herbal and dietary supplements within 7 days prior to admission and through 7 days after final discharge. Acetaminophen may be used at doses of ≤ 1 g/day, and ibuprofen may be used at doses of ≤ 1.2 g/day starting no earlier than 48 hours after discharge.
* Agrees not to use nicotine-containing products from screening through 48 hours after discharge.
* Agrees not to consume alcohol for the 72 hours prior to admission and through 48 hours after discharge.
* Agrees not to eat grapefruit or drink grapefruit juice within 7 days prior to admission and through 24 hours after discharge.
* Agrees to not drink caffeinated drinks from 72 hours prior to admission to discharge.
* Agrees not to eat or drink (except water) for 8 hours before and 4 hour after dosing for all SAD cohort participants (applicable to the Food Effect Cohort participants only for the fasted dose).
* Agrees to eat the high-fat standard breakfast 30 minutes pre-dose for participants in Food Effect Cohort.
Exclusion Criteria:
* Individuals with significant previous or ongoing disease or disorder, on the basis of history, physical exam, ECG, and laboratory tests, including for example: Cardiovascular diseases; hypertension; cancer or neoplasia; diabetes; hepatic, endocrine, metabolic, respiratory, renal, gastrointestinal (except appendectomy), dermatological or hematological disorders, Axis I or II psychiatric, substance use, or cognitive disorders.
* Clinically significant infection or inflammation at time of screening or admission.
* Clinically significant abnormalities upon physical/neurological exam at screening.
* Acute gastrointestinal symptoms (e.g. nausea, vomiting, diarrhea) at time of screening or admission
* History of seeking advice from a physician or counselor for abuse or misuse of alcohol, non-medical drugs, medicinal drugs or other substance abuse, for example, solvents.
* Any current or previous use of Class A drugs such as illicit opiate use, cocaine, ecstasy, LSD, and amphetamines (Class B). Volunteers that admit to occasional past use of cannabis will not be excluded as long as they have a negative drugs-of-abuse test at screening and admission and have been abstinent for at least 3 months.
* An alcoholic intake greater than 21 units per week or unwillingness to stop alcohol consumption for the duration of the study. Note: 1 unit = 8 g ethanol (250 mL of beer, 1 glass wine \[100 mL\], 1 measure spirits \[30 mL\]).
* Use of medication (including OTC and oral contraceptive agents) within 14 days of admission that may affect the safety of the subject or any study assessment, in the opinion of the investigator.
* Use of prescribed centrally active or psychoactive agents within 28 days from admission.
* Requirement for any medication that would need to be continued during the study.
* Use of any investigational medication within 3 months prior to the start of this study or scheduled to receive an investigational drug during the course of this study.
* Have participated in more than 2 clinical trials within the 12 months prior to screening
* History of blood donation in the last 3 months.
* History of severe allergies or multiple adverse drug reactions.
* Any condition, which compromises ability to give informed consent or to communicate with the investigator as required for the completion of this study.
* The subject has been previously enrolled in the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT03220295
Study Brief:
Protocol Section:
NCT03220295