ALKS 8700

IGISIS assessed the intensity of five individual GI symptoms: nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea. Participants rated the intensity of each individual symptom via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme). IGISIS was completed by the participants using e-diaries.

An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal assessment such as an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAE is any AE that start or worsen on or after the date of first dose of study treatment. An SAE is any untoward medical occurrence that at any dose, results in death; in the view of the investigator places the participant at immediate risk of death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; is a medically important event.

Vital sign measurements included heart rate (low: \<=50 beats per minute \[bpm\] and decrease \>=15 bpm; High: \>=120 bpm and increase \>=15 bpm), systolic blood pressure (BP) (low: \<=90 millimeters of mercury \[mmHg\] and decrease \>=20 mmHg; High: \>=180 mmHg and increase \>=20 mmHg) and diastolic BP (low: \<=50 mmHg and decrease \>=15 mmHg; High: \>=105 mmHg and increase \>=15 mmHg).

Potentially clinically significant QTcF values (\>450 to \<=480 millisecond \[msec\], \>480 to \<=500 msec) at any post-baseline visit during treatment period were reported.

The C-SSRS is a clinician-administered instrument that systematically assess suicidal ideation and behavior rating scale. It rates an individual's degree of suicidal ideation (SI) on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent." The scale identifies SI severity and intensity, which may be indicative of an individual's intent to commit suicide. C-SSRS SI severity subscale ranges from 0 (no SI) to 5 (active SI with plan and intent). The scale identifies specific behaviors ranging from "preparatory acts or behavior" to "suicide" which may be indicative of an individual's intent to complete suicide.

Laboratory assessments included hematology, biochemistry, and urinalysis. Abnormality criteria: \>=3xupper limit of normal (ULN) in alanine aminotransferase, aspartate aminotransferase; In millimoles per liter (mmol/L) \[bicarbonate\<15/\>31, chloride\<=90, potassium\<3/\>5.5, sodium\<130/\>150\]; In mg per decilitre(mg/dL) {total bilirubin\>=2.0, calcium\<8.2/\>12, total cholesterol\>300, creatinine\>=2.0, glucose\<50/\>200, cholesterol: High density lipoprotein (HDL)\<=30, low density lipoprotein (LDL)\>=160, triglycerides\>=120 \[female(F)\]/\>=160 \[male(M)\], urate\>9/\>8(F), blood urea nitrogen\>30}; \>3xULN in creatine kinase, lactate dehydrogenase; Hematocrit \<=32(F)/\<=37(M) percentage(%),3 point decrease from baseline; Hemoglobin\<=9.5(F)/\<=11.5(M)g/dL; Lymphocytes\<0.5x10\^9/L; In 10\^3/microliter(uL) \[Eosinophils\>1; Absolute neutrophils\<1.5; Platelets\<75.1/\>=700; Leukocytes\<=2.8/\>=16\]; Albumin/creatinine\>200g/kilograms(kg); Beta-2 microglobulin \>0.3milligrams/liter(mg/L); Glucose/protein at least 2+.