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ICON Early Phase Service Clinical Trial for for healthy non-smoking Adults ages 18-55 (BR 4585-0013 MAD) in San Antonio, TX

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ICON Early Phase Services is conducting a research study for healthy non-smoking Adults ages 18-55. The purpose of this study is to evaluate the safety and effect of an investigational drug to treat HIV. Different doses of the study drug in oral liquid form are being evaluated in this study. You will be given the study drug orally 3 times.

 

Phase: I

Health Conditions: Healthy Volunteers Studies

Reference #: BR 4585-0013 MAD

Sponsored by: ICON Early Phase Services
Stipend: $15,015
Length of Study: 6 Weeks

Additional Qualifying Information / Important Inclusions or Exclusions: 

Gender: Both
Age: 18 – 55
In-patient or stay overnight at the research centre? Yes

 

Vital signs, ECGs, physical examinations, drug, alcohol and tobacco testing will be performed. Blood, nasopharyngeal and urine samples will also be obtained during this study.

Participants will complete:

  • Screening visit
  • 28 Consecutive overnights
  • 2 Outpatient visits (Day 35 and 42)

The length of the study from the first admit to end of study is approximately 42 days.

To determine if you fully qualify, it will be necessary to obtain blood samples after an 8- hour fast. You have the option of fasting for the screening appointment, or, you may return later. For more information, see below.

Qualified participants may be compensated up to $15,015 for study completion.

If you are able to answer “YES” to the following statements, you may qualify for this study.

  • I am a healthy non-smoking male or female, meaning no significant medical conditions
  • I am between 18 and 55 years old
  • My BMI is between 18.5 and 32.0 kg/m2 and my weight is equal to or greater than 110 pounds (for men) and is equal to or greater than 99 pounds (for females).
  • My GFR is greater than 80 mL/min
  • I have not participated in a clinical trial and received an investigational drug within 30 days (or 5 half-lives) prior to dosing

 

If Female, I meet one of the following:

  • Postmenopausal (no menses for 12 months)
  • Surgically sterile (hysterectomy, documented tubal ligation, documented tubal occlusion or documented bilateral oophorectomy)
  • Abstinence- who have established, long-term lifestyle of sexual abstinence, or only same sex partners, require no other means of birth control.
  • Vasectomy for male partners (of female subjects who are able to get pregnant). Confirmed with documentation of azoospermia (absence of sperm in semen)
  • Child bearing and currently use one of the following (and agree to comply from the 1st dose of study medication until 30 days after last dose of study medication ) with a male condom–
  • Contraceptive subdermal implant that meets the effectiveness criteria including a <1% rate of failure per year, as stated in the product label.
  • Oral contraceptive, either combined or progestogen alone or injectable progestogen.
  • Contraceptive vaginal ring
  • Contraceptive patches.
  • Intrauterine device or intrauterine system that meets the effectiveness criteria including a <1% rate of failure per year, as stated in the product label

 

If Male, I agree to refrain from sperm donation and use one of the following and agree to comply from the 1st dose of study medication until 30 days after last dose of study medication :

  • Vasectomy with documentation
  • Male condom plus
  • Contraceptive subdermal implant that meets the effectiveness criteria including a <1% rate of failure per year, as stated in the product label.
  • Oral contraceptive, either combined or progestogen alone or Injectable progestogen.
  • Contraceptive vaginal ring
  • Contraceptive patches.
  • I have suitable veins for multiple blood samples
  • I am able to communicate effectively in English with the study personnel

 

Screening Reminders –

  • 8 hours fasting is required for lab work (only water is allowed)
  • If taking medications, bring them to your screening appointment.
  • Bring a valid, non-expired photo ID with you when you attend your screening visit. We accept a government issued identification card such as a driver’s license, state issued ID card, military ID or passport. You will be required to show this same photo ID at all study visits.
  • Arrive 30 minutes before your appointment to complete paper work.

ICON Early Phase Services

8307 Gault Ln, San Antonio, TX 78209, USA

Click to call Clinic

ICON Early Phase Service

Study Scavenger Provides the Below Helpful Information

In-Patient/Out-Patient Explained

There are two main reasons clinical research trials are done in an isolated inpatient setting where the patient stays overnight at a research clinic: 1) To protect the study participant:   Some study agents, usually challenge products, can make some people quite sick.  Study participants stay on the inpatient unit to receive 24 hour nursing care during these types of studies. Participants stay on the isolation unit until their laboratory test show they are no longer shedding the infectious agent.  2) To protect the public:  An infectious study agent that is given to a study participant may be harmful to the general public’s health.  Therefore, study participants stay on the inpatient unit until the possibility of giving the infection to someone else has passed.

An outpatient vaccine trial is a study that does not require an overnight stay in the hospital or research clinic.  Participants are given an investigational agent and have scheduled clinic visits to monitor how well they tolerate the investigational agent. Most studies require the clinic staff to follow up with subjects on a daily, weekly or monthly schedule.  Clinic visits can range from 2 to 4 hours, depending on the study and the type of visit.  –  National Institute of Health

Screening Visit

Screening Visit:  Potential candidates for a Study will participate in an initial screening visit to determine if they are appropriate for the Study.  When you first attend the screening visit for phases I-III, the study is explained in detail and you can ask any questions. If you decide to participate, the study nurse will review the informed consent form with you and ask for your signature and permission to proceed with the screening evaluations. –  –  National Institute of Health

Washout Period Explained

A period during a clinical trial when the trial subjects receive no active medication. The wash-out period is typically used to generate patient baseline data.   Every clinic has a washout period during which you are not allowed to do a study at the same clinic or any other clinic.

The minimum period is 30 days since last dose, however some washouts go based on last study procedure (such as out patient visits or how much blood you gave during the study).   The washout period may vary from study to study depending on the half-life of the drug. Certain studies like radio-labeled drugs will have a 1 year washout before you can do another radio-labeled drug.   In addition to the clinic’s washout policy, the sponsor may impose a longer washout period.  Some studies will have a longer washout before you can sign up.

In general, you can sign up and screen for another study during the washout period as long as the check in date is at least 30 days after your last dose in the previous study.  However, depending on how fast your body recovers from a study, you may want to wait the full period to avoid problems with screening.

People who screen too soon after a study typically have lower red blood cell, hemoglobin, hematocritand iron.  If these levels are too low, you could get banned from participating in studies because having low levels is unhealthy and unsafe for participating in a study.

Be forewarned that many clinic participate in the VCT (Verified Clinical Trials) program which tracks when you do a study to ensure the next study meets washout periods.  I do not mention these clinics because it shouldn’t matter.  You know the rules and if you break them, the consequences can be dire like being banned from a clinic.  Sometimes the only way to drive this message home is to allow people to find out the hard way. –  –  National Institute of Health

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