Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Lexicon Pharmaceuticals
Age
18–55
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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
You may not be if
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
Clareo Health | An Open-Label Drug-Drug Interaction Study of Telotristat Etiprate and Fexofenadine in Healthy Subjects
