Phase
Condition
N/ATreatment
Fingerprint sweat laboratory analysis
Fingerprint sweat drug screen
Clinical Study ID
Ages 18-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Informed of the nature of the study, agreed to, and able to read, review, and signthe informed consent document prior to dosing. The informed consent document will bewritten in English; therefore, the subject must have the ability to read andcommunicate in English.
*Completed the screening process within 30 days prior to dosing. Subjects screenedas a part of an IRB-approved General Screening Protocol at the clinical researchsite may be included in this study without additional screening procedures, providedall the required screening procedures have been performed within 30 days prior todosing.
Healthy male and non-pregnant female subjects from ages 18 to 65, inclusive, at thetime of dosing.
*Body mass index (BMI) from 18 kg/m2 to 30 kg/m2, inclusive, and weigh at least 60kg.
*Females of childbearing potential must be willing to practice an acceptable form ofcontraception (see Section 9.3.3), and have a negative urine pregnancy test onadmission to the treatment phase of the study.
*Males must agree to practice an acceptable form of contraception.
*Judged by the Investigator and/or designee to be in good health as documented bythe medical history, and vital sign assessments. Any abnormalities or deviationsoutside the normal range for vital signs can be repeated by clinical staff andjudged to be not clinically significant for study participation.
Exclusion
Exclusion Criteria:
Unwilling or unable to provide informed consent.
*More than three digits absent from the hands due to congenital or accidentalcause(s).
*Reports receiving any investigational drug within 30 days prior to dosing.
*Reports a clinically significant illness during the 30 days prior to the in-clinicportion of the study (as determined by the Investigator).
*Reports any personal history of substance abuse (including drug/alcohol abuse oraddiction) or mental illness (e.g. major depression) within one year prior toscreening visit.
*Is pregnant (females only).
*Presence of any clinically significant results from laboratory tests and vitalsigns assessments, as judged by the Investigator.
*Reports history of respiratory depression (e.g., sleep apnea).
*Current severe hypotension (i.e., systolic blood pressure <90 mmHg).
*Reports known or suspected gastrointestinal obstruction including, paralytic ileus.
*Reports current presence of acute bronchial asthma/ upper airway obstruction.
*Reports a history of clinically significant allergies, including food or drugallergies, as judged by the Investigator.
*Reports history or current condition of adrenal insufficiency.
*Reports history or current condition of renal disease.
If, in the opinion of the Investigator, the subject is not suitable for the study.
- Required only for "donors." Not required for "operators."
Study Design
Study Description
Connect with a study center
CenExel iResearch
Decatur, Georgia 30030
United StatesActive - Recruiting
CenExel HRI
Berlin, New Jersey 08009
United StatesActive - Recruiting
CenExel HRI
Marlton, New Jersey 08053
United StatesActive - Recruiting
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