Phase 1 ALKS 1140 in Healthy Adults

Phase 1TerminatedNCT05019105

Alkermes, Inc.20 enrolled

Overview

To evaluate the safety and tolerability of ALKS 1140 in healthy adult subjects

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Central Nervous System Diseases

Interventions

PlaceboDRUG

Oral matching placebo

ALKS 1140DRUG

Active oral dose of ALKS 1140

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Body mass index (BMI) ≥18 and \<30 kg/m2 Exclusion Criteria: * Clinically significant illness or disease including significant cardiac, gastrointestinal (stomach) * Subjects who have known allergic reactions to food or medications * Women of childbearing potential * Any clinically significant lifetime history of suicidal behavior or ideation (thoughts) * Subject had lymphoma, leukemia, or any malignancy within the past 5 years

Locations (1)

Alkermes Clinical Investigative Site

Brisbane, Australia

Outcomes

Primary Outcomes

Incidence of treatment-emergent adverse events

Time frame: Up to 28 days

Change in Columbia-Suicide Severity Rating Scale (C-SSRS)

Change in C-SSRS measured in Multiple-Ascending Dose subjects only

Time frame: Up to 28 days

12-lead safety ECG results

ECG parameters (Heart Rate, RR, PR, QRS, QT, QTcF, T wave) will be analysed using descriptive summary statistics (mean, standard deviation, median, minimum, and maximum for continuous variables) and as a change from baseline by dose level and treatment group. For the QT interval assessment, clinically abnormal ECG results for QTcF will be tabulated by protocol-specified millisecond range categories by dose and treatment group. Potentially clinically significant findings will be summarized by dose and treatment group.

Time frame: Up to 28 days

Secondary Outcomes

Maximum plasma concentration (Cmax) for ALKS 1140

Time frame: Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours and Day 29

Time to Cmax (Tmax)

Time frame: Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours and Day 29

Half-life (t1/2) of ALKS 1140

Time frame: Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours

Time until first quantifiable concentration (tlag)

Time frame: Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours and Day 29

Area under the concentration-time curve (AUC)

Time frame: Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours and Day 29

Data from ClinicalTrials.gov

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