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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Drug Interactions

Intervention / Treatment
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* Drug: Telotristat etiprate
* Drug: Octreotide acetate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Period 1<br>Single oral dose of 500 mg telotristat etiprate on Day 1 | Drug: Telotristat etiprate<br>* 500 mg telotristat etiprate<br>|
| Other: Period 2<br>Subcutaneous injections of 200 µg octreotide acetate three times daily with a single oral dose of 500 mg telotristat etiprate on Day 6 | Drug: Telotristat etiprate<br>* 500 mg telotristat etiprate<br>Drug: Octreotide acetate<br>* 200 µg octreotide acetate three times daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentrations of telotristat ethyl |  | Days 1, 2, 3, 6, 7, 8 | 
| Plasma concentrations of metabolite LP-778902 |  | Days 1, 2, 3, 6, 7, 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of treatment-emergent adverse events |  | Up to 39 days |