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 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT01757860
Eligibility Criteria:
Inclusion Criteria:
1. Healthy males and females between the ages of 18 and 55, inclusive, with body mass index (BMI) between 18-32 kg/m2.
2. Females must be surgically sterile or at least 2 years post-menopausal. Menopausal status will be verified by a follicular stimulating hormone (FSH) test. Those with bilateral tubal ligation must also use a barrier method of birth control. In addition, all females must have a negative pregnancy test at Screening.
3. No clinically significant findings on physical examination, including BP, pulse rate and 12-lead ECG. No clinically significant medical history.
4. No clinically significant safety laboratory results at Screening. Cardiavent, Inc. - CONFIDENTIAL
5. Nonsmoker or light smoker (≤5 cigarettes per day or similar use of other tobacco products) and are willing to refrain from smoking while in the clinic.
6. Willing and able to sign an informed consent document indicating understanding the purpose of and procedures required for the study and willingness to participate in the study.
7. Willing and able to stay in the clinic for the inpatient activities required by the protocol for all visits.
Exclusion Criteria:
1. Evidence of clinically relevant pathology that could interfere with the study results or put the subject's safety at risk.
2. Current or recurrent disease that may affect the action, absorption, or disposition of the study treatment, or clinical or laboratory assessments.
3. Current or relevant previous history of serious, severe, or unstable (acute or progressive) physical or psychiatric illness, any medical disorder requiring treatment or that may make the subject unlikely to fully complete the study, or any condition that presents undue risk from the study treatment or procedures.
4. History of febrile illness within the 5 days prior to the first dose.
5. Positive Hepatitis B surface antigen (HbsAg), Hepatitis C antibody or Human Immunodeficiency Virus (HIV) test result at Screening visit.
6. Use of any prescription medication or over-the-counter (OTC) medication within 7 days or 5 half-lives (whichever is longer) prior to the first dose of trial medication or during the study. As an exception, acetaminophen may be used at doses up to 1 g/day.
7. Use of any herbal supplements (including herbal weight-loss or "metabolism booster" therapies) within 30 days prior to the first dose of trial medication.
8. Known or suspected intolerance or hypersensitivity to similar study drugs or excipients, closely related compounds or any of their stated ingredients.
9. Positive screen for alcohol or drugs of abuse during Screening visit or at study check-in for Day 1 dosing.
10. Participated in a clinical study involving an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to study drug administration.
11. Blood donation of 1 pint or more within 56 days of the start of the study.
12. Plasmapheresis or plasma donation within 30 days of the start of the study.
13. Single 12-lead ECG demonstrating QTc \>450 msec at Screening, and or history or evidence of long QT syndrome. A single repeat ECG may be done at the Principal Investigator's discretion.
14. Any condition that in the opinion of the Principal Investigator would complicate or compromise the study or the well-being of the subject.
15. Unwilling or unable to comply with the clinic house rules.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01757860
Study Brief:
Protocol Section:
NCT01757860