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 males or females ≥18 to ≤55 years of age
Body mass index 18.0 to 32.0 kg/m2, inclusive, at Screening
Vital signs (after at least 5 minutes resting in a supine position) at Screening that are within the following ranges: Systolic blood pressure, 90 to 140 mm Hg; Diastolic blood pressure, 50 to 90 mm Hg; Heart rate 40 to 100 beats per minute (bpm)
Willing to adhere to the prohibitions and restrictions specified in this protocol
Able to comprehend and willing to sign an Informed Consent Form
You may not be if
Presence of clinically significant physical, laboratory, or electrocardiogram (ECG) findings at Screening or Check-in (Day 1) that, in the opinion of the Investigator and/or the Sponsor or Sponsor's representative, may interfere with any aspect of study conduct or interpretation of results
Use of any medications (prescription or over-the-counter), herbal tea, energy drinks, herbal products (eg, St. John's Wort, garlic, milk thistle, etc.), or supplements/supratherapeutic doses of vitamins within 14 days prior to the first dose administration and throughout the duration of the study, with the exception of those approved by the Investigator and/or the Sponsor or Sponsor's representative
Prior exposure to telotristat etiprate
Use of tobacco, smoking cessation products, or products containing nicotine within 3 months prior to Screening and for the duration of the study
History of any major surgery within 6 months prior to Screening
History of renal disease
History of hepatic disease, or significantly abnormal liver function tests (\>1.5 x upper limit of normal \[ULN\])
History of gall bladder abnormalities
History of any endocrine disorder
History of alcohol or substance abuse within 2 years prior to Screening
Positive urine screen for drugs of abuse and cotinine
Consumption of caffeine- and/or xanthine containing products (eg, cola, coffee, tea, chocolate) within 72 hours prior to Check-in
Consumption of alcohol within 48 hours prior to Check in
Consumption of grapefruit, Seville oranges, and grapefruit- or Seville orange containing products within 72 hours prior to Check in
