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:
2025-12-24 @ 10:39 PM
Ignite Modification Date:
2025-12-24 @ 10:39 PM
NCT ID:
NCT02195635
Eligibility Criteria:
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02195635
Study Brief:
Protocol Section:
NCT02195635