Phase 1, Open-label, Drug-drug Interaction Study With Octreotide Acetate Injection and Telotristat Etiprate in Healthy Subjects



Status:Recruiting
Healthy:No
Age Range:18 - 55
Updated:11/8/2014
Start Date:July 2014
Contact:Mike Kelly, Clinical Trial Manager
Phone:281-863-3026

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A Phase 1, Open-label, Single-center, 2-period, Single Sequence Drug-drug Interaction Study to Evaluate the Effects of Octreotide Acetate Injection (Sandostatin®) on the Pharmacokinetics of Single-dose Telotristat Etiprate in Healthy Male and Female Subjects

To evaluate the effect of octreotide acetate injections (200 µg 3 times daily [tid]) on the
pharmacokinetics (PK) of telotristat ethyl and its metabolite LP-778902 relative to
administration of single-dose telotristat etiprate in healthy male and female subjects


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
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Daytona Beach, Florida 32117
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Daytona Beach, FL
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