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

Drug Interactions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02195635
• Other study ID #: LX1606.1-109-NRM
• Secondary ID: LX1606.109
• Status: Completed
• Phase: Phase 1
• First received: July 17, 2014
• Last updated: September 6, 2016
• Start date: July 2014

Study information

• Verified date: September 2016
• Source: Lexicon Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Drug Interactions

Intervention

Drug:
• Telotristat etiprate
500 mg telotristat etiprate
• Octreotide acetate
200 µg octreotide acetate three times daily

Locations

Country	Name	City	State
United States	Lexicon Investigational Site	Daytona Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Lexicon Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentrations of telotristat ethyl		Days 1, 2, 3, 6, 7, 8	No
Primary	Plasma concentrations of metabolite LP-778902		Days 1, 2, 3, 6, 7, 8	No
Secondary	Number of treatment-emergent adverse events		Up to 39 days	Yes