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 @ 12:08 AM
Ignite Modification Date:
2025-12-25 @ 12:08 AM
NCT ID:
NCT02157558
Eligibility Criteria:
Inclusion Criteria:
* Healthy adult subjects aged ≥18 to ≤55 years of age at screening
* Body mass index ≥18.0 to ≤32.0 kg/m\^2
* Acceptable vital signs at Screening: Systolic blood pressure = 90-140 mm Hg, Diastolic blood pressure = 50-90 mm Hg, Heart rate = 40-100 beats per minute
* Willingness to adhere to the restrictions outlined in the protocol
* Able to comprehend and sign the Informed Consent Form
Exclusion Criteria:
* Presence of any clinically significant physical, laboratory, or ECG finding that may interfere with the study in the opinion of the Investigator
* Use of any medications, herbal tea, energy drink, herbal products, or supplements within 14 days of Day 1
* Receipt of any investigational agent or study drug within 30 days or 5 half-lives prior to Screening
* Receipt of any protein- or antibody-based therapeutic agent within 3 months of Screening
* Prior exposure to telotristat etiprate
* Use of tobacco, smoking cessation products, or nicotine products within 3 months prior to Screening
* History of major surgery within 6 months prior to Screening
* History of any GI surgery that may induce malabsorption
* History of any serious adverse reaction or hypersensitivity to any component of fexofenadine
* History of renal disease, or significantly abnormal glomerular filtration rate (\<90 mL/min as calculated using the Cockcroft-Gault equation) at Screening
* History of hepatic disease, or significantly abnormal liver function tests at Screening
* History of any clinically significant psychiatric, renal, hepatic, pancreatic, cardiovascular, neurological, endocrinologic, hematological, or GI abnormality
* History of any active infection within 14 days prior to first dosing
* History of alcohol or substance abuse within 2 years prior to Screening
* Positive hepatitis panel (including hepatitis B surface antigen and hepatitis C virus antibody) or positive human immunodeficiency virus antibody screens
* Concurrent conditions that could interfere with safety and/or tolerability measurements
* Donation or loss of \>500 mL of blood or blood product within 3 months prior to Screening
* Women who are breastfeeding or are planning to become pregnant during the study
* Positive serum pregnancy test (females only)
* Positive urine screen for selected drugs of abuse and cotinine
* Consumption of alcohol within 48 hours prior to study start
* Consumption of caffeine- and/or xanthine-containing products within 72 hours of study start
* Consumption of grapefruit, Seville oranges, and grapefruit- or Seville orange-containing products within 72 hours prior to study start
* Unable or unwilling to communicate or cooperate with the Investigator for any reason
* Use of any drugs or substances that are known to be substrates, inducers, or inhibitors of CYP3A4 within 30 days prior to the first dose
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02157558
Study Brief:
Protocol Section:
NCT02157558