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

Sponsored by Lexicon Pharmaceuticals

About this trial

Last updated 9 years ago

Study ID

LX1606.1-109-NRM

Status

Completed

Type

Interventional

Phase

Phase 1

Placebo

No

Accepting

18-75 Years
18 to 55 Years
All
All

Trial Timing

Started 11 years ago

What is this trial about?

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

What are the participation requirements?

Yes

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

No

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

Locations

Location

Status