Healthy MY 3853-0007

  • STATUS
    Recruiting
Updated on 9 June 2020

Summary

ICON Early Phase Services is conducting a research study for healthy adults ages 18-45. This study is being done to test a potential anti-fungal drug.

Medical history, vital signs, ECGs, physical examinations and pregnancy, drug, alcohol and tobacco screens will be performed. Blood and urine samples will also be obtained during this study.

Description

Participants will complete:

  • 1 screening visit
  • 4 consecutive overnights
  • 3 outpatient visits

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 at a later date. If ICON does not have your medical records on file, you will need to provide medical records at screening.

Details
Condition *Healthy Volunteers
Clinical Study IdentifierTX245631
Last Modified on9 June 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

If you are able to answer “YES” to the following statements, you may qualify for this study
I am a healthy adult, meaning no significant medical conditions
I am between 18 and 45 (inclusive) years old
My BMI is between 18.0 and 35.0 kg/m2 (inclusive) and I weigh at least 110 lbs
I have not received any study product in a clinical trial within 30 days prior to Screening
If Female, I am not pregnant or breastfeeding and I do not plan to become pregnant during the study or for 3 months after last dose
If Female and capable of becoming pregnant, I agree to use a highly effective method of birth control from 30 days before enrollment through the 3 months after dosing. Methods of birth control include
successful tubal obliteration (e.g., Essure®)
long-acting reversible contraception (prgestin-resleasing subdermal implants, copper intrauterine devices (IUDs)
levonorgesterel-releasing IUDs
If Female and not capable of becoming pregnant, I have been postmenopausal for at least 2 years or I am permanently surgically sterile (tubes tied, ovaries removed, tubes removed, uterus removed)
If Male and I have a partner capable of becoming pregnant, I agree to consistently use a condom from first dose through 3 months after last dose. (NOTE: This includes vasectomized males.)
I have not recently used tobacco (e.g., vaping, smoking, snuff, chewing tobacco or other nicotine or nicotine-containing products)
I agree not to use any tobacco or nicotine-containing products for the duration of the study and to abide by the rules of the clinic, which is a non-smoking facility
I am able to communicate effectively in English with the study personel
I do not have a chronic disease and I have not been recently treated for a chronic disease
I do not have a history of a psychiatric condition that required hospitalization
I do not have a recent history of illicit drug use or alcohol abuse
I have not recently used prescription drugs. (NOTE: Hormonal contraceptives are permitted.)
I have not recently used non-prescription medications, vitamins, or dietary supplements. (NOTE: Acetaminophen dosage of 2 g/day is allowed. Herbal supplements must be discontinued prior to first dose.)
I have not recently donated blood or experienced significant blood loss
I am able to avoid consumption of beverages and foods containing caffeine as required by the study
I am able to avoid consumption of grapefruit, juices that contain grapefruit, and Seville oranges as required by the study
I do not have any dietary restrictions that would conflict with participation in a fed or fasted cohort
I do not have a sensitivity or allergy to aspirin
I am able to swallow whole capsules or tablets and/or multiple capsules or tablets
I have not had problems having blood drawn in either arm
It is important to understand that even if you feel that you meet all the above criteria, you are still required to complete the protocol screening procedures
Scheduling a screening appointment does not guarantee that you will qualify for that study. Additionally, subjects are screened on a first come-first served basis and studies may complete enrollment prior to your visit
No guarantees can be made regarding group assignments for any particular study. ICON will not assume any liability for losttime, travel or failure to qualify
To determine if you fully qualify, it will be necessary to obtain blood and urine samples after an 8-hour fast. You have the option of fasting for a blood or urine sample at the screening appointment, or, you may return at a later date for us to obtain these samples
If you fast, you should refrain from eating or drinking anything (with the exception of water) for 8 hours before your appointment. We will be testing for tobacco, alcohol and drug abuse. Please refrain from consuming alcohol at least 24 hours prior to your screening appointment
Be sure to bring all of your medications with you to your screening appointment
Please note, you need to 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
You will be filling out paperwork for the study. Please arrive at least 30 minutes in advance of your screening appointment. If you are late for your appointment you may not be seen or may need to reschedule
Be advised that you may need to provide medical records as part of the screening process for this study. If possible, please bring your full medical records with you to your screening appointment. If you cannot bring your records with you, you must provide them before you can admit to the study. Note that full medical records include surgical reports
Other Details: Qualified participants may be compensated up to $2,000 for time and travel
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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