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 |
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
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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