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 @ 9:22 PM
Ignite Modification Date:
2025-12-24 @ 9:22 PM
NCT ID:
NCT00063804
Eligibility Criteria:
Inclusion Criteria for all participants:
* HIV uninfected males in good general health
* Normal electrocardiogram (EKG) and lab values
* Body weight within 33% of ideal weight for height within 28 days of study entry
* Willing to refrain from exercise for 24 hours prior to study entry
* Willing to use acceptable forms of contraception
Inclusion Criteria for Group 3's Additional Study:
* Willing to refrain from consumption of alcohol and grapefruit juice for the duration of the study
Exclusion Criteria for all participants:
* Prescription medications, herbal supplements, or aspirin within 7 days of study entry
* Nonsteroidal anti-inflammatory drugs, over-the-counter medications, and other supplements (including multivitamins) within 1 day of study entry
* Active infection or acute illness within 14 days of study entry
* Drug or alcohol abuse or dependence
* Known sensitivity to AMD070
* History of gastrointestinal bleeding or ulcer
* Any medical or psychological condition that, in the opinion of the investigator, would interfere with study participation
Exclusion Criteria for Group 3:
* Immunizations within 30 days of study entry
* Radiation therapy, cytotoxic chemotherapeutic agents, or immunomodulating agents within 30 days of study entry
* Chronic diarrhea for more than 4 weeks prior to study entry
* Heart conduction abnormalities, heart arrhythmias, cardiomyopathy, any repolarization delay, or other risk factors for heart failure and hypokalemia
Exclusion Criteria for Group 3's Additional Study:
* Grade 3 or 4 adverse event while participating in Group 3
* Consumption of alcohol within 48 hours of study entry
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT00063804
Study Brief:
Protocol Section:
NCT00063804