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 @ 3:47 AM
Ignite Modification Date:
2025-12-25 @ 3:47 AM
NCT ID:
NCT05070702
Eligibility Criteria:
Inclusion Criteria:
* Generally healthy with the exception of those medical conditions allowed per the study criteria
* Able to provide voluntary, written informed consent with comprehension of all aspects of the protocol, prior to any study procedures
* Body Mass Index (BMI) of 18.5 to 32 kg/m2 and weight \>48 kg
* Systolic Blood Pressure (BP) of 90-140 mmHg, Diastolic BP of 40-90 mmHg and Heart Rate between 40 and 100 bpm
* Forced Expiratory Volume in one second (FEV1) \> 85% predicted
* Clinical laboratory results at screening and Day -1 to be within normal limits unless deemed as not clinically significant by the investigator
* Willing to consume bovine containing products (investigational product capsules are bovine gelatin in origin);
* Agree not to donate blood or plasma products for at least 30 days after the end of study (EOS) visit
* Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at Day -1, must not be breastfeeding, lactating or planning a pregnancy and must use an acceptable form of contraception during the treatment period and for 32 days after the last dose
* Male participants with a female partner of childbearing potential must agree to use an acceptable form of contraception during the treatment period and for 92 days after the last dose
Exclusion Criteria:
* Significant current or historical disease, including intercurrent illness in the 4 weeks prior to screening
* Current or historical diagnosis of sleep disorders
* Hepatic disorders other than benign unconjugated hyperbilirubinaemia
* History of moderate or severe psychiatric illness
* History of severe allergy or anaphylaxis to any drug, food, toxin or other exposure
* Heavy caffeine drinker in the last 3 months. If subjects are willing to reduce their caffeine intake for 14 days prior to first dose and for the duration of the study, they can participate
* Hypersensitivity to CT-1500 or any of the inert excipients in the capsule formulation
* Positive hepatitis B surface antigen (HBsAg), positive hepatitis C antibody (HCV) or positive human immunodeficiency virus (HIV) test
* Treatment with an investigational drug within 30 days or less than 5 half-lives (whichever is longer) prior to screening
* Use of prescription medication within 14 days prior to investigational product administration until the end of study visit, with the exception of oral contraceptives.
* Use of over-the-counter medication and supplements for 7 days prior to investigation product administration until the end of study visit. Exceptions at the discretion of the investigator.
* Receipt of a Coronavirus disease 2019 (COVID-19) vaccine within 14 days prior to investigational product administration or a planned second dose of a COVID-19 vaccine during study participation
* Use of tobacco or nicotine-containing products in excess of 2 cigarettes per day within 1 month prior to screening
* Major surgery in the 6 months preceeding screening or planned surgery during the study
* Donated blood or blood products or had a substantial loss of blood with 3 months prior to screening
* A history of drug abuse or addiction
* A history of alcoholism or consumption of more than 3 alcoholic drinks per day or consumption of alcohol within 48 hours prior to first dose
* Unable to abstain from grapefruit-containing foods or beverages or Seville orange-containing foods or beverages from 48 hours prior to investigational product administration until completion of the confinement period;
* Unable to avoid heavy exercise (eg, marathon runners, weight-lifters) from 48 hours prior to investigational product administration until completion of the confinement period
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT05070702
Study Brief:
Protocol Section:
NCT05070702